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TranscriptFY2026 Q22026-08-06FY2026 Q2 earnings call transcript
Earnings source - 80 paragraphs
FY2026 Q2 earnings call transcript
Welcome, everyone. Thank you for joining HUTCHMED 2026 interim results announcement and presentation. Before we start, I would just like to go over the safe harbors statement and disclaimer on page two. The performance and results of operation of HUTCHMED Group contained within this presentation are historical in nature, and past performance is no guarantee of future results. Next, I would like to invite our Acting CEO and CFO, Johnny Cheng, to start the opening. Johnny?
Thank you, David, and welcome everyone again joining our interim results webcast tonight. Together with me, we have our Deputy CFO, Lorenso Chiu, also our George Yuan, Head of Commercial, and also our Dr. Dai, Head of Discovery and Global Portfolio Management. All of us will be sharing with you our first half results and outlook. On page four, as you can all see, we have achieved a lot in the first half. China product sales have very strong results, especially ELUNATE and SULANDA, which grew by over 40%. FRUZAQLA global in-market sales were strong. Ex-U.S. markets were up 70% after rapid geographic expansion. On the bottom left, we have received two approved label expansions, fruquintinib for RCC and savolitinib for GC. In addition, we have three NDAs in China under priority review. On the top right, our next wave of innovation focuses on ATTCs.
We have two first-in-class assets which have entered the phase I clinical trials. A third asset, HMPL-A830, has cleared its IND and will be entering the clinic in the second half. At the same time, the global SAFFRON study and the China SANOVO study will have their data readouts in the second half. I will now hand it over to Lorenso Chiu, our Deputy CFO, to discuss our financial results.
Thank you, Johnny. On slide number six, I'd like to give more details of our financials for the first half of 2026. First of all, our oncology revenue was $162 million, including $121 million products revenue. This represent an about 23% growth over the first half of 2025. Johnny already mentioned our China product sales have shown a very good performance in the first half. I'd like to highlight that ex-China demand for FRUZAQLA continues to grow as well, achieving an overall 40% growth in in-market sales. With this first half result, our full year guidance remains in the range of $330 million-$415 million. Altogether with other ventures revenue, the total group revenue amounted to $278 million. Next, please. On R&D expenses, which amounted to $79 million for the first half, compared to $72 million for the first half of 2025.
The increase reflects on one thing, we initiate the global phase I trials of our ATTC assets, including 251 and 580. In addition, we increase our investments in our discovery capabilities, including our talents and AI. On the bottom line, we continue to be profitable with net income of $16 million. It is important to note in last years, we have included a $460 million SHPL divestment gain, and also the share of the post divestments, about $21 million. With this strong operating results and cash flows, we continue to have a very good cash reserve of $1.4 billion. Now I'd like to hand over to Mr. George, our Head of Commercial, to give an update of our China commercial.
Thanks, Lorenso. As Johnny mentioned, global geographic expansion continue to drive our FRUZAQLA growth. If we look at the first half, we see a 70% growth in the geography outside the U.S., which is very strong. If you look at the Q2, the growth rate actually accelerate to 27%. We still believe that there still has opportunity to get more country get launched and also go into the reimbursement. Takeda already confirmed the fiscal year guidance of a 25% growth. Next slides. If we look at China, we have a very robust growth for ELUNATE. We are in a highly competitive market. If we look at the first half, we are growth at 41%, and the current NRDL renewal bring us a continuous growth opportunity with the second-line mCRC included. We synchronize our mCRC reimbursement scope with our label.
The NRDL renewal actually provide us a unique opportunity for future growth, we keep our price flat. Second-line RCC get approval in May 26, this provides us another opportunity to apply for NRDL this year. Based on IQVIA hospital audit and our ATU study, ELUNATE continue to be a market leader in third-line mCRC. Next slides. Beyond FRUZAQLA and ELUNATE, we also have a strong performance on ORPATHYS and SULANDA. ORPATHYS, we are target to include such indication in this year NRDL, renew by end of this year, we get approval third-line MET-amplified GC. In the coming months, we are looking at SAFFRON and SANOVO readout. For SULANDA, we have strong growth in first half based on the highly recommend by CSCO guideline for the NET. The CSCO guideline change the recommendation about the SSA.
The SSA, dose escalation will not be recommend after the disease progression. This growth is a result our focus strategy focus on top-tier city and the top hospitals. Next slides. Looking to the future, sovleplenib, our Syk inhibitor, will bring us into the hematology immunology fields. This is the first-in-class medicine, and it can help patients to transform their treatment in both ITP and wAIHA. If we look at the ITP in China, we have 360,000 patients, and the current treatment, TPO, steroids, still cannot meet the medical needs of those patients. With this product, we provide a very unique value for those patients for long-term, stable, predictable disease control. Also for wAIHA, which is a relatively small indication, but it's under critical needs for new medicine. We will be the first target therapy after 30 years in the field.
We will significantly reduce blood infusion for those patients. Now, I will hand over to our R&D, Dr. Dai.
Thank you, George. Now, let's transition into our R&D updates. Over the next few slides, I'll share how our late-stage clinical programs are progressing toward key commercial approvals and how our innovative platform is unlocking brand-new opportunities to address major unmet medical needs. Next slide, please. Looking at our recent achievements, we've hit several critical milestones across both solid tumors and hematology. Our novel ATTC platforms represent a huge strategic growth driver for us globally. The early biological profiles of ATTCs gives us high confidence in their ability to target major solid tumors and differentiate from other ATTC products. We've officially taken the first two ATTCs into the clinic, A251 and A580, initiating global phase I trials. The third ATTC, A830, recently cleared the IND in both the U.S. and in China. We secured approval for fruquintinib in renal cell carcinoma in June 2026.
This is another important approval for fruquintinib after CRC and in mCRC. With surufatinib, we have kept momentum strong with our phase III trial in first-line PDAC fully on track, addressing an aggressive cancer type with very few viable options. Savolitinib, our second inhibitor, is making rapid progress on lung cancer autoimmune indications. The NDAs for ITP and wAIHA are currently under priority review. These mark huge steps towards establishing a new, highly effective standard of care in these conditions. The pivotal phase III data of ESLIM-02 was recently presented at EHA this year. Savolitinib expanded its commercial footprint with the third-line gastric cancer approval. This is the fourth regulatory approval for savolitinib after previous lung cancer approvals. 760, our potent PI3K/BTK inhibitor, successfully initiated its phase III trial in second-line DLBCL. Fanregratinib reached a pivotal moment with its NDA acceptance for FGFR positive intrahepatic cholangiocarcinoma.
The data was featured at ESMO GI this year. Together, these achievements reflect a highly efficient R&D engine, strengthening our commercial presence today while laying the foundation for our global ATTC platform tomorrow. Next slide. Let's dive a bit deeper into our individual core assets, starting with savolitinib, our second potential global commercial product. Savolitinib targets lung cancer driven by MET alterations, which remains an area of significant unmet medical need. We are fast approaching several important milestones. In the second half of this year, we expect data readouts from two key studies, SAFFRON on a global scale and SANOVO in China. SAFFRON is our global registration phase III trial. It targets second-line patients with EGFR mutant non-small cell lung cancer who developed MET amplification or overexpression after progressing on TAGRISSO. Currently, these patients are on heavy chemotherapy.
SAFFRON directly compares our oral combination of savolitinib plus TAGRISSO against double chemotherapy. When approved, this trial will replace chemotherapy with an oral target option and opening access to major markets like the U.S. and Europe. SANOVO targets the first line setting. We know that a significant subset of lung cancer patients present with coexisting EGFR mutations and MET overexpression right at initial diagnosis. SANOVO evaluates combining savolitinib with TAGRISSO directly upfront versus TAGRISSO alone. By attacking both targets from day one, our goal is to deliver deeper response and prevent resistance from emerging. Together with our proven phase III SACHI data, which showed a dramatic hazard ratio of 0.32 in PFS over chemotherapy, these upcoming readouts from SAFFRON and SANOVO position savolitinib to capture leadership across the entire treatment paradigm in MET-driven lung cancer. Next slide.
This slide highlights sovleplenib, which is spearheading our next wave of hematology and autoimmune products. wAIHA is a deliberating disease where red blood cells are destroyed prematurely, leaving patients severely anemic and often they rely on high-dose steroids and frequent blood transfusions. In our phase III ESLIM-02 study presented at EHA, sovleplenib achieved a 66% durable response rate compared to 15% in the placebo group. Patients on sovleplenib reached target hemoglobin levels in a median of 3.1 weeks, twice as fast as the placebo. Substantial drop in rescue therapy and transfusion. Only 16% of sovleplenib patients require rescue therapy, compared to 54% on the placebo. Red blood cells transfusions were significantly reduced to just 11% versus 43% in the control group, allowing the patients to taper or completely discontinue their baseline steroids.
When you compare this to the emerging peer options like nipocalimab, sovleplenib shows a clear competitive efficacy advantage, delivering a much higher durable response rate, without forcing patients to stay on a chronic high risk immunosuppressants. We are eager to bring sovleplenib to a patient population that hasn't seen a new target therapy option in 30 years, and currently, the NDA is under priority review. In ITP, what sets sovleplenib apart from standard care agents like TPOs and TPO-RAs is exceptional efficacy without associated thrombotic complication warnings found on their peer labels. In ITP, sovleplenib achieved a striking durable response rate compared to placebo, even though 75% of the enrolled patients had failed prior TPO therapies. ESLIM-01 study is also under priority review in China. Next slide.
Turning to slide 17, let's look at 760, our highly potent selective and reversible BTK inhibitor characterized by long target engagement. Currently, this is the only BTK inhibitor in late-stage clinical development targeting the second line DLBCL all comers. Our phase II study showed encouraging response rate, PFS, and safety profile. Our phase III registration study in China is actively ongoing, comparing 760 in combination with R-GemOx against the placebo plus R-GemOx, with primary endpoints of PFS and OS. We expect to complete enrollment by the end of 2027. Next slide, please. Here, I want to highlight our novel ATTC platform, starting with A251. ADCs, like in HER2, have transformed HER2-positive cancer treatment, generating billions in revenue. However, acquired resistance to DXd, the cytotoxic payload used in HER2, remains a major clinical hurdle as patients inevitably progress.
The DXd induced in resistant model on the bottom show that in HER2 loses potency almost completely, shifting the curve far to the right. In the same resistant cell model, because A251 utilizes completely distinct mechanisms targeting the PI3K and PI3K signaling pathways rather than DNA-damaging toxins. Its killing activity in DXd-resistant cells, shown in the green curve, remains identical to DXd-sensitive parent cells, shown in the blue curve. Next slide. Beyond treating drug-resistant tumors, A251 has strong potential as a frontline treatment, as shown in this gynecological cancer and GI cancer xenograft models. Combining A251 with the first-line standard of care yields significant tumor volume reduction compared to either therapy alone.
Crucially, this synergistic effect does not come at the cost of added toxicity, proving A251 can safely be combined, which is what we aim to achieve with ATTCs in the first place, which is better efficacy and better safety. Our clinical strategy is twofold. A monotherapy track for a fast-to-market approach in late-line setting, and a combination track targeting frontline indications. Our extensive pre-clinical data support the A251 development strategy. The clinical trial is on track at dose escalation stage. Next slide. Our second ATTC asset is 580, which pairs the same payload with an EGFR targeting antibody. Blockbuster drugs like Tagrisso treat EGFR mutant non-small cell lung cancer, but resistance eventually develops.
In a non-small cell lung cancer model carrying the challenging EGFR exon 19 deletion and the resistant mutation, third generation TKIs like Tagrisso completely lose control of tumor growth, as shown by the red curve. 580, represented by the blue curve, achieved profound and sustained tumor regression as a single agent. This highlights its enormous potential for lung cancer patients. Next slide. By combining 580 with an EGFR inhibitor, we can simultaneously shut down primary receptor signaling and the downstream escape pathways. The pre-clinical data reflects a highly significant synergistic anti-tumor efficacy, supporting our long-term plan to move this asset into frontline cancer regimens. This global asset entered phase I trial earlier this year. The trial is going very well, recruiting patients from China sites and the U.S. sites in parallel. Next slide. What makes our ATTC platform so unique is the payload itself.
Historically, the industry has struggled with pan-pathways, pan-PI3K or dual PI3K inhibitors. Small molecules were simply too toxic to be delivered systemically, resulting in severe side effects like hyperglycemia or mucositis. Single node inhibitors were safer, but their efficacy was limited. Our innovation was to design a highly selective payload that harvests multiple key nodes along both the PI3K and PIKK pathways with very high affinity, and then tether it to an antibody. This ensures the payload is delivered inside the tumor cells, maximizing intracellular kinase inhibition while sparing healthy tissues from systemic toxicities. The kinase tree on the right illustrates this high selectivity of the payload. Next slide. The ATTC approach opens up massive opportunities. The pan-pathway is the single most frequently altered pathway across all solid tumors. It plays a dominant role in breast cancer, lung cancer, gastric and ovarian cancers.
By effectively targeting this pathway with our ATTC technology, we can potentially reach millions of patients across a wide range of cancer types. Next slide. With A251 and 580 currently in global trials, A30 entering the clinic soon, and more candidates behind them, our pipeline is well-positioned to deliver a sustained growth for years to come. Thank you. I'll give it back to Johnny.
Thank you, Dr. Dai. A quick highlight on our outlook. On the innovation side, as mentioned by Dr. Dai, multiple ATTC programs are progressing well, and we believe around this time next year, there should be a total of five programs already in clinics. More importantly, our efforts in AI will be transforming and accelerating further discovery and development in our innovation platform. On the commercial side, we expect FRUZAQLA's sales growth to continue. We anticipate it will reach its next sales milestone in the near term. Regarding our hematology portfolio, our commercial team is preparing for the launch of our immunology asset, which is anticipated to commence next year. Finally, we are continuing to engage many multinational companies on collaboration discussion regarding our ATTC program. I will now pass it back to David to begin our Q&A session.
Thank you, Johnny. We will now start our Q&A session. Before we start, I would like to repeat the instructions to ask question. On the bottom of your screen, you can see the Raise Hand button. Just press on that button. We will call out your name and unmute your line. When you start, please do mention the name of your company as well as your name. The first question comes from Matthew of CLSA.
Matthew, you can now go ahead and talk. Thanks.
Hi, thank you for taking my question. This is Matthew from CLSA. I have three questions. First is regarding the collaboration opportunities for the ATTC programs, two in clinic and one about to be in clinic. Could you elaborate more on the kind of progress, because I think that there's been some expectation of the maybe early-stage collaboration before. Yeah, can you comment on that? Second one is regarding your HMPL-760, the BTK inhibitor. Yeah, as you mentioned, you have got initiate the phase III trial for DLBCL in China. May I understand how is this drug different from other BTK inhibitors, and why would you choose the DLBCL to proceed for phase III, as there are no other BTK inhibitors approved for these indications, including the covalent ones and also the non-covalent ones are non-approved.
The third question is regarding on the financial side. I know that the Other Ventures is a low-margin distribution business, but may I still have some color on why in the first half is on a constant exchange rate basis declined by almost 20%? Okay, that's my questions. Thank you.
Thank you, Matthew. I will invite Dr. Dai to answer the second question, and Lorenzo to answer the last question. The first question regarding the collaboration opportunity, basically, we are continuing, and we have active multinational companies engaging in discussion with us on not just one program, but multiple ATTC program. As you know that our programs are still at the very early stage, so different expectation in terms of timeline and information to be provided from our side to the collaborate potential partners. They have kind of different requirements. All I can say right now it is we are in active discussions with multiple parties, and the discussions are progressing well. When I think the discussions is coming to a close to mature and is disclosable items, then we will be making an announcement to the public.
Maybe Dr. Dai, you can answer the question number 2 regarding the 760 BTK.
Sure. Johnny. Yes, we have actually started phase III study, with HMPL-760. It is a combination of HMPL-760 plus R-GemOx versus R-GemOx. We pick DLBCL, obviously, because it is the largest lymphoma subtype, accounting for about 40% of lymphoma. No other BTK inhibitors has been approved for this particular subtype of lymphoma. It represents a huge unmet medical need and good market potential. With our HMPL-760, it is reversible BTK inhibitor, and in earlier clinical study, it demonstrated a very good selectivity and safety profile. We actually had a phase II study validating its efficacy in the second-line setting. It is the same study design, and we achieved a very impressive overall response rate and the CR rate, and a very favorable safety profile to encourage us to go into the phase III study.
It is a very exciting opportunity for HMPL-760, and we hope to achieve the enrollment completion as fast as we can. Thank you.
Yep. Johnny, I will answer question three. As for the Other Ventures, I think you are right to point out that our Other Ventures is a low-margin business, which is not our focus. We are putting our focus on our major oncology revenues. As you can see, the growth is there. That is the reason that there was some decline in the Other Ventures business. I do not think we need to look into too much about behind this, because, as you said, it is low margin and it is not our core. Maybe I just supplement that. I think as highlighted by Lorenzo, this is not our core business. It is basically, it is a logistic distribution business. The reason there has been some decline is because of the volume-based procurement list has actually in China have been expanded.
Some of the previously our customers in the logistic distribution side have actually affected by the volume-based procurement, in terms of their selling price and so forth. That services business is not what we focus, basically because of the high working capital requirement for this business. As a way to manage this business, we try to just maintain this line of business to help to gain insights into the commercial channel in Shanghai. I think that the drop, it does not actually affect the bottom line. It does not affect in terms of the entire business operation of HUTCHMED.
Okay, that's very clear. Thank you very much.
Thank you, Matthew. Thank you, Johnny. The next question is from Chen Chen of UBS. Chen Chen, we will now open up your line. Your line is now unmute.
Sure. Thank you for taking my questions. My first question is on sovleplenib. This candidate is expected to receive approval next year. Could you please elaborate on your commercial preparation strategy in China, including pricing, marketing access, and NRDL, and your sales force? In addition, what are your overseas R&D plans and priorities for this asset? My second question is on ATTC. What is the expected timeline for clinical data readout from your candidate one and two? Thank you.
Thank you. May I ask George to answer the first question and Dr. Dai do a second question?
Thanks, Chen Chen. For sovleplenib launch preparation, we are focused on few area. First thing is market access, value proposition. We need to make sure this product's going to the NRDL, and we expect this product to get approval maybe in the first half next year and qualify for the NRDL negotiation. One of the challenges is how can we position us very well to achieve affordable and realistic price in this disease. One of the understanding is we will do a kind of HE data based on our clinical trial.
On the other side, we also would like to work with a patient group, with opinion leaders, to understand the pain points of the current treatment and try to make sure we really leverage those patient insights to make sure the government understand there's a main needs and there's a quality of life, a kind of compromising for those patients who receive other treatments. This will help us to leverage the future. On the other side, we definitely will do the guideline, we do the KOL, as well as a physician education program, also a patient advocacy group as well. If you look at the current setup for the launch, we have already built up a dedicated hematology team with a lot of experienced people in the hematology side.
We are starting to work with our partners to understand the market potential, try to figure out what's our first wave target hospitals, territories, and the resource deployment.
I'll get the second question. The first and second ATTC assets are both in the middle of phase I dose escalation. The trials are moving very fast. Enrollment has been going strong in the U.S. and in China sites. Investigators are very excited about the novel mechanisms and the differentiation. They understand the rationale, and they are enthusiastic about the new mechanism of the ATTCs. We will find the right time to disclose the clinical data sometime in 2027. Thank you.
Got it. Thanks, George and Dr. Dai.
Thank you.
Thank you, Chen Chen. The next question comes from Paul Choi of Goldman Sachs. Go ahead.
Hi, can you hear me?
Yes, we can. Thanks.
Hi. Thank you. Good morning, good evening. I want to talk a little bit about first ask on sovleplenib as you sort of look at the warm autoimmune hemolytic anemia landscape, just sort of the other products or candidates that are in that category, how do you think about potential developments and planning for a global trial outside of China? Just sort of any additional thoughts on what aspects or differentiation are needed there? I had a follow-up question.
Dr. Dai? Yeah.
Of course.
George, yeah.
HMPL-523, now both studies in ITP and wAIHA were completed in China. We are waiting for CDE's feedback on our NDA data. In ex-China, our strategy is to develop this asset through partnership.
Thank you. Any thoughts on, again, sort of what clinical differentiation might be needed versus development strategy?
Right now, the treatment paradigm, for example, for wAIHA, the first-line is mainly the steroids, like George mentioned earlier. We are targeting the second-line patients, which doesn't have a lot of choices other than the steroids. The unmet medical need is very high in China as well as in the U.S. As you can tell from our phase III data, the overall durable response rate looks very promising compared to the other competitors, which is FcRn antibody product. We think this asset has great potential, so we are actively looking for partnership to co-develop this asset outside the China.
Yeah, maybe I can add because this wAIHA is regarded as a rare disease, and we also have a plan to apply U.S. orphan drug status.
Okay, great. Thanks for that clarification. My second question is on HMPL-453 fanregratinib. You advanced it through the second line ICC population on the oncology side. I want to ask what your thoughts are on potential endocrinology applications such as achondroplasia and other bone growth disorders, and if you think this might be a potentially appropriate candidate there. Thank you.
With HMPL-453, our main focus right now is intrahepatic cholangiocarcinoma, second line. We have started the confirmatory trial to get this indication confirmed in the same setting. Thank you.
Thank you.
Thank you, Paul. The next question comes from Adam McCarter of Cavendish. Adam, your line is now unmuted.
Hi there. Yeah, thanks for taking the questions. A couple of questions from me just on the commercial portfolio. Obviously it was encouraging to see the recovery across ELUNATE and SULANDA. Just on ORPATHYS, you did highlight the opportunity for NRDL inclusion following the SACHI based approval. I am just wondering how significant do you think that could be commercially? Do you expect that to be a key driver of a recovery in China sales, or is the more meaningful inflection point still this de novo readout and the opportunity to further broaden adoption? That is my first question.
George, you would like to answer that one?
Yeah. I think the SACHI inclusion in the NRDL will significantly improve the growth potential for the brand. Because if we look at the data, if you look at the EGFR-resistant patients, there are quite significant amount of patients with MET amplification. So far, there is no other choice. The bispecific monoclonal antibody in China is not included in the NRDL from Johnson & Johnson. We still have a growth potential. Also, this combination will extend the TAGRISSO treatment duration as well, and as well as kind of levers for AstraZeneca to compete with other TKIs. That is why we believe that this is a strong growth potential. Having said that, also one of the hurdle is that we still need a secondary biopsy, so there is a kind of adoption at practice in the medical side.
That's great. Thanks very much for clarifying. My second question, again, on the commercial side of things is for FRUZAQLA. Just wondering how we should think about the growth trajectory for U.S. sales going forward. Should we now be thinking about a period of steadier growth with ex-U.S. markets becoming an increasingly more important contributor to incremental growth for the brand?
Okay, maybe I'll just comment on this one. I think for FRUZAQLA, for the last year almost, I think there was some Medicare impact in terms of the gross to net. As you can see, the growth momentum is through the geographic expansion of the ex-U.S. markets in the first half especially. We have looked at 70% growth there. Also, I think one point to note is although the geographic has expanded, the NRDL in those market is only 50% so far. We believe there will still be a lot of opportunity for ex-U.S. Earlier, we have also shared with all of you that from our information from Takeda, that they expect U.S. side, basically, the size of U.S. peak sales versus the rest of the world will be kind of a 50/50 ratio.
We believe there's still a lot of growth momentum behind this global sales of FRUZAQLA.
Great. Thank you. If I could chance maybe a final question, just on, obviously, reiterate the guidance. Could you just help us try and understand the key drivers that determine whether the business lands towards the lower or the upper end of the range? In other words, should we primarily be thinking about the contribution from milestones, continued recovery of the China portfolio, or ongoing growth in ex-China for FRUZAQLA revenues? Thank you.
Well, I think, as you can note that in the first half, the guidance for this year is actually RMB 330 million-RMB 450 million. With our base line achievement, it is without any business development contribution in there. We will be at least beating the lower end of the guidance. With certain potential partnering, which we recognize some upfront income, that we can reach higher or even exceeding the high end of the guidance. That is the range. Also other factor that can affect the second half is, as we mentioned, FRUZAQLA, that we do anticipate that it will reach another level of sales milestone that would contribute, again, some one-time commercial milestone income that would also help us to meeting or even exceeding our target that we have given out to the market.
We are quite confident that we will be able to achieve this guidance that we have given out to the market earlier.
Great, thank you very much for answering my questions.
Thank you, Adam. Just to repeat the instruction, if you have any question, do press the raise hand button at the bottom of your screen. The next question comes from Julie Simmonds of Panmure. Julie.
Thank you for taking the question. Thank you.
Thank you.
Julie Simmonds from Panmure Liberum. Just again, on the milestones. There was a milestone in the first half from Takeda. I was just wondering what that related to. Then beyond the sales milestones to which you just referred, are there any other milestones anticipated? I was wondering if there was anything due from Astra on the SAFFRON trial readout.
No. Actually, in the first half, just to clarify, it was from the approval of the RCC renal cell carcinoma, so it was from Eli Lilly. Yeah. In terms of our second half, besides the sales milestone, so far we do not expect any other milestones from our partners yet. In terms of if we achieve good results for our sovleplenib, we will be receiving milestones more likely next year, not this year.
Lovely, thank you very much. Just as far as sort of the overall margins are concerned, you've done slightly better, I think, probably in terms of sort of balance between sales and spending than maybe I'd thought you might do. Is the aim to continue to remain, to try to continue to be broadly breakeven to slightly profitable going forwards in your sort of thinking of how the business is going and using the cash in potential business development activities?
Yes, definitely. I think it is a strong commitment, requirement by our board that we will continue to be breakeven. That's a commitment that we made a couple of years back.
This is a strong commitment from all our management team. This is not going to be changing. Of course, we will balance with investment in area definitely that would drive growth and creating value for the shareholders. That's why we're accelerating ATTC program. At the same time, of course, we are exploring business development opportunity with our partners so that we can basically creating, accelerating our ATTC innovation opportunity.
Lovely. Thank you.
Thank you, Julie. Again, if there's any question, please do press the raise hand button. At this moment, I don't see any further question online. Johnny, would you like to make a concluding remark?
Yes. I thank you everyone for joining this interim results. We look forward to meeting again, I think, in later on. We will be planning for a R&D day sometime later this year. We will make relevant announcement in due course. Thank you.
Thank you, everyone. This conclude our interim result presentation. Thank you. Bye-bye.
Bye-bye.
Investor releaseQuarter not tagged2026-07-30HUTCHMED (China) Ltd (HCM) (H1 2026) Earnings Call Highlights: Strong Product Sales Growth and ...
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HUTCHMED (China) Ltd (HCM) (H1 2026) Earnings Call Highlights: Strong Product Sales Growth and ...
This article first appeared on GuruFocus. Release Date: July 30, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Strong China product sales growth, with Elunate and Zolenta growing over 40%. Fruquintinib global in-market sales grew 70% in ex-US markets due to rapid geographic expansion. Two new drug approvals received: fruquintinib for RCC and savolitinib for GC. Novel ATTC platform advancing with two first-in-class assets in Phase 1 trials and a third cleared for IND. Company remains profitable with net income of $60 million and a strong cash reserve of $1.4 billion. R&D expenses increased to $79 million from $72 million due to investments in ATTC trials and discovery capabilities. Other ventures revenue declined by nearly 20% due to expanded volume-based procurement in China. Full-year guidance range of $330 million to $450 million is wide, with lower end dependent on no business development contributions. No additional milestones expected from partners in the second half beyond a sales milestone for fruquintinib. ATTC clinical data readouts not expected until 2027, leaving near-term pipeline catalysts limited. Warning! GuruFocus has detected 8 Warning Signs with HCM. Is HCM fairly valued? Test your thesis with our free DCF calculator. Q: Regarding collaboration opportunities for the ATTC programs, could you elaborate on the progress? A: (Acting CEO & CFO Johnny Chen) We are continuing active discussions with multiple multinational companies on not just one program but multiple ATTC programs. The discussions are progressing well, but as our programs are still at a very early stage, different partners have different expectations regarding timelines and information. We will make an announcement when discussions mature to a disclosable stage. Q: Could you elaborate on your commercial preparation strategy in China for SovLapnib, including pricing, market access, NRDL, and sales force? What are your overseas R&D plans for this asset? A: (Head of Commercial George Yuan) For the launch, we are focused on market access and value proposition, aiming for NRDL negotiation. We will use clinical data, work with patient groups and opinion leaders to highlight unmet needs and quality-of-life issues. We have already built a dedicated hematology team with experienced people and are working with partners to understan…Read full documentShow less
This article first appeared on GuruFocus. Release Date: July 30, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Strong China product sales growth, with Elunate and Zolenta growing over 40%. Fruquintinib global in-market sales grew 70% in ex-US markets due to rapid geographic expansion. Two new drug approvals received: fruquintinib for RCC and savolitinib for GC. Novel ATTC platform advancing with two first-in-class assets in Phase 1 trials and a third cleared for IND. Company remains profitable with net income of $60 million and a strong cash reserve of $1.4 billion. R&D expenses increased to $79 million from $72 million due to investments in ATTC trials and discovery capabilities. Other ventures revenue declined by nearly 20% due to expanded volume-based procurement in China. Full-year guidance range of $330 million to $450 million is wide, with lower end dependent on no business development contributions. No additional milestones expected from partners in the second half beyond a sales milestone for fruquintinib. ATTC clinical data readouts not expected until 2027, leaving near-term pipeline catalysts limited. Warning! GuruFocus has detected 8 Warning Signs with HCM. Is HCM fairly valued? Test your thesis with our free DCF calculator. Q: Regarding collaboration opportunities for the ATTC programs, could you elaborate on the progress? A: (Acting CEO & CFO Johnny Chen) We are continuing active discussions with multiple multinational companies on not just one program but multiple ATTC programs. The discussions are progressing well, but as our programs are still at a very early stage, different partners have different expectations regarding timelines and information. We will make an announcement when discussions mature to a disclosable stage. Q: Could you elaborate on your commercial preparation strategy in China for SovLapnib, including pricing, market access, NRDL, and sales force? What are your overseas R&D plans for this asset? A: (Head of Commercial George Yuan) For the launch, we are focused on market access and value proposition, aiming for NRDL negotiation. We will use clinical data, work with patient groups and opinion leaders to highlight unmet needs and quality-of-life issues. We have already built a dedicated hematology team with experienced people and are working with partners to understand market potential and plan resource deployment. (Dr. Dai, Head of Discovery and Global Portfolio Management) For ex-China, our strategy is to develop this asset through partnership. Q: What is the expected timeline for clinical data results from your ATTC candidates one and two? A: (Dr. Dai) The first and second ATTC assets are both in the middle of Phase 1 dose escalation. The trials are moving very fast with strong enrollment in the US and China. Investigators are very excited about the novel mechanism. We will find the right time to disclose the clinical data sometime in 2027. Q: On the commercial portfolio, how significant do you think the NRDL inclusion for Sablitinib following the SACHI-based approval could be? Is it a key driver or is the Synovo readout a more meaningful inflection point? A: (George Yuan) The NRDL inclusion will significantly improve the growth potential for the brand. There is a significant amount of patients with MET amplification and no other choice. This combination will also extend Tagrisso treatment duration. However, we still need adoption in medical practice. Q: How should we think about the growth trajectory for US sales of Fruquintinib going forward? Should we think of a period of steadier growth with ex-US markets becoming more important? A: (Johnny Chen) The growth momentum is through geographic expansion of the US market, with 70% growth in the first half. Although geographic expansion has occurred, NRDL in those markets is only 50% so far, so there is still a lot of opportunity for ex-US. Takeda expects US peak sales versus the rest of the world to be a 50/50 ratio, so there is still strong growth momentum. Q: Could you help us understand the key drivers that determine whether the business trends towards the lower or upper end of the guidance range? A: (Johnny Chen) The guidance for this year is $330 million to $450 million. Without any business development contribution, we will at least meet the lower end. With potential partnering income, we can reach the higher end or exceed it. Also, we anticipate Fruquintinib will reach another sales milestone in the second half, contributing one-time commercial milestone income. We are confident in achieving this guidance. Q: There was a milestone in the first half from Takeda. What did that relate to? Are there any other milestones anticipated, such as from Astra on the Saffron trial readout? A: (Johnny Chen) The milestone in the first half was from the approval of the RCC renal cell carcinoma from Eli Lilly. In the second half, besides the sales milestone, we do not expect any other milestones from partners. If we achieve good results for Sablitinib, we will receive milestones more likely next year, not this year. Q: Is the aim to continue to remain broadly break-even to slightly profitable going forward, balancing with potential business development activities? A: (Johnny Chen) Yes, it is a strong commitment from our board and management team to continue to be break-even. This is not going to change. We will balance this with investments in areas that drive growth and create value for shareholders, such as accelerating the ATTC program and exploring business development opportunities with partners. Q: Regarding HMPL-760, the BTK inhibitor, how is this drug different from other BTK inhibitors and why did you choose DLBCL for the Phase 3 trial? A: (Dr. Dai) We chose DLBCL because it is the largest lymphoma subtype, accounting for about 40% of lymphoma, and no other BTK inhibitors have been approved for this subtype. It represents a huge unmet medical need and good market potential. Our 760 is a reversible BTK inhibitor with good selectivity and safety. Our Phase 2 study validated its efficacy in the second-line setting with impressive overall response rate, CR rate, and favorable safety profile, encouraging us to proceed to Phase 3. Q: Why did the "other ventures" revenue decline by almost 20% on a constant exchange rate basis in the first half? A: (Deputy CFO Lorenzo Jiu) The other ventures business is a low-margin distribution business, which is not our focus. The decline is due to the volume-based procurement list expanding in China, affecting some of our customers in the logistic distribution side. (Johnny Chen) This is not our core business. We try to maintain this line to gain insights into the commercial channel in Shanghai, but it doesn't affect the bottom line or entire business operation. For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Investor releaseQuarter not tagged2026-07-30HUTCHMED H1 Earnings Call Highlights
MarketBeat
HUTCHMED H1 Earnings Call Highlights
Interested in HUTCHMED (China) Limited Sponsored ADR? Here are five stocks we like better. HUTCHMED remained profitable in H1 2026, reporting $162 million in oncology revenue, up 23% year over year, and $16 million in net income. The company ended the period with $1.4 billion in cash and maintained full-year oncology revenue guidance of $330 million to $415 million. Commercial growth was led by China sales of ELUNATE and SULANDA, both up more than 40%, while global FRUZAQLA in-market sales rose 40% and sales outside the U.S. increased 70%. Management said FRUZAQLA’s international growth runway remains significant because reimbursement coverage is about 50%. The company advanced its pipeline with upcoming savolitinib data readouts, positive Phase III results for sovleplenib in warm autoimmune hemolytic anemia, and the launch of a Phase III trial for HMPL-760 in diffuse large B-cell lymphoma. HUTCHMED is also holding discussions with multinational companies about potential collaborations for its ATTC programs. HUTCHMED (NASDAQ:HCM) reported first-half 2026 oncology revenue of $162 million, including $121 million in product revenue, as growth in China and expanding international sales of FRUZAQLA supported results. The company maintained its full-year oncology revenue guidance of $330 million to $415 million and said it remained profitable during the period. Acting CEO and CFO Johnny Cheng said the company recorded strong China product sales, particularly for ELUNATE and SULANDA, both of which grew by more than 40%. He also cited strong global in-market sales for FRUZAQLA, with markets outside the U.S. increasing 70% following geographic expansion. → Why SK hynix Could Be the Best AI Chip Stock to Buy Now Deputy CFO Lorenso Chiu said oncology revenue increased about 23% from the first half of 2025. FRUZAQLA demand outside China contributed to the performance, with overall in-market sales growth of 40%, according to Chiu. Total group revenue, including Other Ventures revenue, was $278 million. Research and development expenses rose to $79 million from $72 million a year earlier, reflecting the initiation of global Phase I trials for the company’s ATTC assets, including A251 and A580, as well as increased investment in discovery capabilities, talent and artificial intelligence. → 3 Value ETFs to Consider as Growth Stocks Lag Behind HUTCHMED reported net income of…Read full documentShow less
Interested in HUTCHMED (China) Limited Sponsored ADR? Here are five stocks we like better. HUTCHMED remained profitable in H1 2026, reporting $162 million in oncology revenue, up 23% year over year, and $16 million in net income. The company ended the period with $1.4 billion in cash and maintained full-year oncology revenue guidance of $330 million to $415 million. Commercial growth was led by China sales of ELUNATE and SULANDA, both up more than 40%, while global FRUZAQLA in-market sales rose 40% and sales outside the U.S. increased 70%. Management said FRUZAQLA’s international growth runway remains significant because reimbursement coverage is about 50%. The company advanced its pipeline with upcoming savolitinib data readouts, positive Phase III results for sovleplenib in warm autoimmune hemolytic anemia, and the launch of a Phase III trial for HMPL-760 in diffuse large B-cell lymphoma. HUTCHMED is also holding discussions with multinational companies about potential collaborations for its ATTC programs. HUTCHMED (NASDAQ:HCM) reported first-half 2026 oncology revenue of $162 million, including $121 million in product revenue, as growth in China and expanding international sales of FRUZAQLA supported results. The company maintained its full-year oncology revenue guidance of $330 million to $415 million and said it remained profitable during the period. Acting CEO and CFO Johnny Cheng said the company recorded strong China product sales, particularly for ELUNATE and SULANDA, both of which grew by more than 40%. He also cited strong global in-market sales for FRUZAQLA, with markets outside the U.S. increasing 70% following geographic expansion. → Why SK hynix Could Be the Best AI Chip Stock to Buy Now Deputy CFO Lorenso Chiu said oncology revenue increased about 23% from the first half of 2025. FRUZAQLA demand outside China contributed to the performance, with overall in-market sales growth of 40%, according to Chiu. Total group revenue, including Other Ventures revenue, was $278 million. Research and development expenses rose to $79 million from $72 million a year earlier, reflecting the initiation of global Phase I trials for the company’s ATTC assets, including A251 and A580, as well as increased investment in discovery capabilities, talent and artificial intelligence. → 3 Value ETFs to Consider as Growth Stocks Lag Behind HUTCHMED reported net income of $16 million and ended the first half with $1.4 billion in cash reserves. Chiu noted that prior-year figures had included a $460 million gain from the divestment of SHPL and approximately $21 million from the post-divestment share. Management said the Other Ventures business, a logistics and distribution operation, declined in the first half as China’s volume-based procurement list expanded. Cheng said the operation is not a core business and that the decline did not affect HUTCHMED’s overall bottom line or operations. → 5 AI Stocks Are Pulling Back—Which Growth Catalysts Still Look Strongest? George Yuan, executive vice president and head of commercial in China, said ELUNATE grew 41% in the first half despite a competitive market. The company said China’s National Reimbursement Drug List renewal included second-line metastatic colorectal cancer, aligning the reimbursement scope with the product’s label while keeping pricing flat. ELUNATE also received approval in May 2026 for second-line renal cell carcinoma, which Yuan said creates an opportunity for an NRDL application this year. Based on IQVIA hospital audit data and an ATU study, the company said ELUNATE remains a market leader in third-line metastatic colorectal cancer. For ORPATHYS, HUTCHMED is targeting NRDL inclusion for third-line MET-amplified gastric cancer by the end of the year. Yuan said inclusion based on the SACHI study approval could improve the product’s growth potential, though secondary biopsy requirements remain an adoption hurdle. SULANDA’s first-half growth was supported by CSCO guideline recommendations for neuroendocrine tumors and the company’s focus on top-tier cities and leading hospitals, Yuan said. Management also highlighted FRUZAQLA’s opportunity outside the U.S. Cheng said reimbursement coverage in those markets is currently about 50%, leaving room for further growth. He added that, based on information from Takeda, the company expects U.S. peak sales and rest-of-world peak sales to represent an approximately 50/50 split. HUTCHMED said it received two label expansions during the first half: fruquintinib for renal cell carcinoma and savolitinib for gastric cancer. The company also has three new drug applications in China under priority review. The company expects second-half data readouts from the global SAFFRON study and China’s SANOVO study of savolitinib. SAFFRON is a global registration Phase III trial evaluating savolitinib plus TAGRISSO against double chemotherapy in previously treated patients with EGFR-mutant non-small cell lung cancer with MET amplification or overexpression. SANOVO is evaluating savolitinib plus TAGRISSO in the first-line setting against TAGRISSO alone in patients with EGFR mutations and MET overexpression. HUTCHMED also discussed sovleplenib, which is under priority review in China for immune thrombocytopenia, or ITP, and warm autoimmune hemolytic anemia, or wAIHA. Dr. Guangxiu Dai, head of discovery and global portfolio management, said the Phase III ESLIM-02 trial in wAIHA showed a 66% durable response rate for sovleplenib versus 15% for placebo. The company said 16% of sovleplenib-treated patients required rescue therapy compared with 54% in the placebo group, while red blood cell transfusions occurred in 11% of patients versus 43% of controls. Yuan said the company is preparing for an anticipated launch of sovleplenib in China next year, including work on pricing, health economics data, physician education, patient advocacy and market access. HUTCHMED has established a dedicated hematology commercial team, he said. Outside China, Dai said the company intends to develop the asset through partnerships and Yuan said it plans to apply for U.S. orphan drug status in wAIHA. Separately, HUTCHMED initiated a Phase III study of HMPL-760, a reversible BTK inhibitor, in second-line diffuse large B-cell lymphoma. The trial compares HMPL-760 plus R-GemOx with placebo plus R-GemOx, with progression-free survival and overall survival as primary endpoints. The company expects enrollment to be completed by the end of 2027. HUTCHMED’s A251 and A580 ATTC candidates have entered global Phase I trials, while HMPL-A830 has cleared investigational new drug applications in the U.S. and China and is expected to enter the clinic in the second half. Dai said the first two programs are in dose escalation, with patient recruitment progressing in both China and the U.S. The company expects to disclose clinical data sometime in 2027. Cheng said HUTCHMED is in active discussions with multiple multinational companies regarding potential collaborations involving more than one ATTC program. He said the company would disclose agreements when discussions become sufficiently mature. Looking ahead, Cheng said HUTCHMED expects FRUZAQLA sales growth to continue and anticipates reaching its next sales milestone in the near term. He said the company’s revenue guidance excludes potential business-development contributions, while future upfront partnership payments or a commercial milestone could help results reach or exceed the upper end of the range. Management also reiterated its commitment to remain broadly breakeven while investing in programs intended to drive future growth. HUTCHMED (NASDAQ: HCM) is a fully integrated biopharmaceutical company focused on discovering, developing, manufacturing and commercializing targeted therapies and immunotherapies for the treatment of cancer and other diseases. The company leverages in-house capabilities in small-molecule chemistry, biologics engineering and translational medicine to advance candidates through all stages of development. HUTCHMED's integrated model encompasses early discovery research, clinical development, regulatory filings and commercial launches, enabling seamless progression from laboratory to market. HUTCHMED's commercial portfolio includes several in-market oncology therapies approved in China, including fruquintinib for metastatic colorectal cancer, surufatinib for neuroendocrine tumors and savolitinib for non-small cell lung cancer. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "HUTCHMED H1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for July 2026.
Investor releaseQuarter not tagged2026-07-30HUTCHMED Reports 2026 Interim Results
GlobeNewswire
HUTCHMED Reports 2026 Interim Results
— China product sales recovery continues led by ELUNATE® and SULANDA® with over 40% growth each — — FRUZAQLA® ex-US sales driving growth – now approved or launched in 41 countries — — Strong progress in ATTCs, a source of novel drug candidates with broad therapeutic potential — HONG KONG and SHANGHAI and FLORHAM PARK, N.J., July 30, 2026 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”, the “Company” or “we”) (Nasdaq/AIM:HCM; HKEX:13) today reports its financial results for the six months ended June 30, 2026 and provides updates on key clinical and commercial developments. All amounts are expressed in US dollars unless otherwise stated. A glossary of abbreviations is on page 25. Global sales growth driven by China rebound and FRUZAQLA® geographical expansion In-market sales from key China commercial products up over 40% compared to the first half of 2025. ELUNATE® (fruquintinib in China) up 41% to $60.8 million as it expanded reimbursement coverage for endometrial cancer and was approved for kidney cancer. SULANDA® up 45% to $18.4 million, boosted by upgraded recommendation in Chinese Society of Clinical Oncology guidelines for neuroendocrine tumors. In-market sales of FRUZAQLA® (fruquintinib ex-China) ex-US up ~70% to $68.9 million during first half of 2026, alongside steady US sales, driven by the need for novel non-chemo treatment options in mCRC and ongoing positive experiences of oncologists in third line setting. Profitability maintained amid higher R&D investment, with net income attributable to HUTCHMED at $15.9 million (H1-25: $455.0m including $416.3m gain on divestment of 45% of Shanghai Hutchison Pharmaceuticals Limited (SHPL)), which allowed the Company to maintain a strong cash balance of $1.37 billion. Multiple first-in-class Antibody-Targeted Therapy Conjugate (ATTC) candidates in clinical trials Initiated clinical trial of HMPL-A251 (PI3K/PIKK-HER2) in December 2025 and of HMPL-A580 (PI3K/PIKK-EGFR) in March 2026 and presented preclinical data at American Association for Cancer Research Annual Meeting. Both ATTCs are progressing through dose escalation as planned. HMPL-A830 clinical trial application approved in July 2026, based on a different ATTC payload platform. Regulatory and clinical achievements across late-stage clinical portfolio New Drug Application (NDA) approval of ELUNATE® with sintilimab for second-line kidney cancer…Read full documentShow less
— China product sales recovery continues led by ELUNATE® and SULANDA® with over 40% growth each — — FRUZAQLA® ex-US sales driving growth – now approved or launched in 41 countries — — Strong progress in ATTCs, a source of novel drug candidates with broad therapeutic potential — HONG KONG and SHANGHAI and FLORHAM PARK, N.J., July 30, 2026 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”, the “Company” or “we”) (Nasdaq/AIM:HCM; HKEX:13) today reports its financial results for the six months ended June 30, 2026 and provides updates on key clinical and commercial developments. All amounts are expressed in US dollars unless otherwise stated. A glossary of abbreviations is on page 25. Global sales growth driven by China rebound and FRUZAQLA® geographical expansion In-market sales from key China commercial products up over 40% compared to the first half of 2025. ELUNATE® (fruquintinib in China) up 41% to $60.8 million as it expanded reimbursement coverage for endometrial cancer and was approved for kidney cancer. SULANDA® up 45% to $18.4 million, boosted by upgraded recommendation in Chinese Society of Clinical Oncology guidelines for neuroendocrine tumors. In-market sales of FRUZAQLA® (fruquintinib ex-China) ex-US up ~70% to $68.9 million during first half of 2026, alongside steady US sales, driven by the need for novel non-chemo treatment options in mCRC and ongoing positive experiences of oncologists in third line setting. Profitability maintained amid higher R&D investment, with net income attributable to HUTCHMED at $15.9 million (H1-25: $455.0m including $416.3m gain on divestment of 45% of Shanghai Hutchison Pharmaceuticals Limited (SHPL)), which allowed the Company to maintain a strong cash balance of $1.37 billion. Multiple first-in-class Antibody-Targeted Therapy Conjugate (ATTC) candidates in clinical trials Initiated clinical trial of HMPL-A251 (PI3K/PIKK-HER2) in December 2025 and of HMPL-A580 (PI3K/PIKK-EGFR) in March 2026 and presented preclinical data at American Association for Cancer Research Annual Meeting. Both ATTCs are progressing through dose escalation as planned. HMPL-A830 clinical trial application approved in July 2026, based on a different ATTC payload platform. Regulatory and clinical achievements across late-stage clinical portfolio New Drug Application (NDA) approval of ELUNATE® with sintilimab for second-line kidney cancer in China in May 2026, supported by FRUSICA-2 Phase III data showing median progression-free survival (PFS) of 22.2 months vs. 6.9 months in control group. NDA acceptance of sovleplenib for warm autoimmune hemolytic anemia (wAIHA) in China in April 2026, supported by ESLIM-02 Phase III data presented at European Hematology Association Congress with durable response rate of 66.0%, along with NDA acceptance for immune thrombocytopenia (ITP) in China in February 2026; both wAIHA and ITP indications received priority review status. Positive SACHI Phase III data of ORPATHYS® in combination with TAGRISSO® (osimertinib) sub-group analysis published in The Lancet in January 2026 with median overall survival (OS) of 22.9 months vs. 7.9 months with chemotherapy. NDA approval for third-line MET-amplified gastric cancer in China in June 2026, supported by Phase II data presented at American Society of Clinical Oncology Annual Meeting with objective response rate of 32.3%. Positive pivotal Phase II data of fanregratinib (FGFR inhibitor) in intrahepatic cholangiocarcinoma presented at European Society for Medical Oncology Gastrointestinal Cancers Congress. Initiated Phase III trial of HMPL-760 (BTK inhibitor) in combination with rituximab and chemotherapy for second-line diffuse large B-cell lymphoma in March 2026. HUTCHMED to host results webcasts today at 8:00 a.m. EDT / 1:00 p.m. BST / 8:00 p.m. HKT in English on Thursday, July 30, 2026, and tomorrow at 8:30 a.m. HKT in Chinese (Putonghua) on Friday, July 31, 2026. After registration, investors may access the live webcast at www.hutch-med.com/event. Dr Dan Eldar, Non-executive Chairman of HUTCHMED, said, “HUTCHMED has a clear strategic focus: to build a globally competitive oncology portfolio anchored by differentiated innovation. This future is shaped by our global first-in-class Antibody-Targeted Therapy Conjugate (ATTC) novel payload platforms and other emerging large-molecule modalities. These give us multiple opportunities to pursue first-in-class or best-in-class assets, with potential to be used in combination with standard-of-care or newer medicines, in turn conferring front-line treatment prospects. As these programs advance, multinational partnerships – some presently under discussion – can provide important external validation, broaden development reach and accelerate access to major international markets. We will continue to invest in our world-class R&D organization and deploy our resources in areas where HUTCHMED can create significant impact on the lives of patients globally, harnessing the most advanced scientific modalities, while creating commercial and shareholder value.” Mr Johnny Cheng, Acting Chief Executive Officer and Chief Financial Officer of HUTCHMED, said, “Strong in-market sales growth from ELUNATE® and SULANDA® in the first half reflects the impact of last year’s streamlining of our salesforce, enhancing productivity with more focused marketing strategies, as we structured our commercial organization to meet the changing China market regulatory guidelines for a sustainable future. We are accelerating ATTC development and strengthening discovery operations through expanding talent and AI capabilities. We are also pursuing business development discussions with multinational partners to expedite global development and commercialization of our most promising programs.” Dr Weiguo Su, Chief Executive Officer (currently on leave of absence) and Chief Scientific Officer of HUTCHMED, said, “The acceptance by the NMPA of the NDA filings for sovleplenib in ITP and wAIHA during the first half of 2026 reflects the strength of the clinical data package, supporting its potential for regulatory and commercial success. Sovleplenib once again attests to the importance of target selectivity, differentiating efficacy and toxicity profiles of our assets. Our ATTC drug candidates are guided by the same principles, designed to navigate our proprietary potent small-molecule targeted therapy payloads to tumor cells while sparing healthy tissues and decreasing side-effects. Pre-clinical data has shown encouraging tumor shrinkage as compared to standard-of-care treatments and emerging therapies recently launched or in development. With three highly novel molecules from two ATTC payload platforms progressing through or about to start first-in-human clinical development, and additional candidates advancing behind them, we are building a science-driven pipeline designed to translate differentiated biology into meaningful clinical benefit.” 2026 INTERIM RESULTS & BUSINESS UPDATES I. COMMERCIAL OPERATIONS There was a strong rebound in China in-market sales, achieving $94.4 million in H1 2026, up 32% vs H1 2025 ($71.6 million) as our sales team continues to improve productivity. This contributed to total in-market sales for oncology products of $279.8 million in H1 2026 (H1-25: $234.4 million). ELUNATE® in-market sales were up 41% to $60.8 million, successfully expanded NRDL coverage to include 2L EMC with pMMR in combination with sintilimab. It also renewed coverage in metastatic CRC for patients who have been previously treated with chemotherapy, and those who have previously received or are not suitable for receiving anti-VEGF or anti-EGFR (RAS wild-type). SULANDA® in-market sales were up 45% to $18.4 million, driven by an update to Chinese Society of Clinical Oncology guidelines upgrading the usage for SULANDA® in neuroendocrine tumors to the highest Level I recommendation standard over competing SSA products. It also benefited from shifting marketing strategies to focus on key hospitals. FRUZAQLA® in-market sales growth was primarily driven by sales outside the US, which had growth of ~70%, contributed by approvals or launches in 41 countries to date, including securing reimbursement in France in Q1 2026 and late 2025 launches in Portugal, Belgium, South Korea and Mexico. This helped boost global in-market sales to $185.4 million. Total consolidated revenue for oncology products increased 23% to $121.4 million as compared to H1 2025, primarily due to strong in-market sales growth in ELUNATE® and SULANDA®. Other Oncology/Immunology revenue, consisting of upfront, regulatory milestones, R&D services and licensing revenue was $40.9 million, including an $18.1 million milestone payment from Eli Lilly, triggered by China approval for 2L RCC. Other Ventures revenue, mainly from prescription drug distribution was $116.0 million, leading to total consolidated revenue of $278.3 million. * FRUZAQLA®, ELUNATE® and ORPATHYS® mainly represent total sales to third parties as provided by Takeda, Eli Lilly and AstraZeneca, respectively. ** FRUZAQLA® represents manufacturing revenue and royalties paid by Takeda to HUTCHMED; ELUNATE® represents manufacturing revenue, promotion and marketing services revenue and royalties paid by Eli Lilly to HUTCHMED, and sales to other third parties invoiced by HUTCHMED; ORPATHYS® represents manufacturing revenue and royalties paid by AstraZeneca to HUTCHMED and sales to other third parties invoiced by HUTCHMED; SULANDA® and TAZVERIK® represent HUTCHMED’s sales of the products to third parties.*** Ipsen is the Marketing Authorization Holder for TAZVERIK®, for which HUTCHMED acts as domestic agent/licensee. In March 2026 Ipsen voluntarily withdrew TAZVERIK® from all Ipsen markets, effective immediately, following emerging safety data from the ongoing SYMPHONY‑1 trial. II. 2026 REGULATORY UPDATES Savolitinib sNDA approved by NMPA in 3L MET-amplified GC in June 2026. Savolitinib MAA approved (temporary authorization) by Swissmedic in combination with TAGRISSO® for 2L EGFRm NSCLC with MET amplification and/or overexpression in February 2026. Fruquintinib sNDA approved by NMPA in combination with sintilimab for 2L RCC in May 2026. Sovleplenib NDA accepted by NMPA for 2L wAIHA in April 2026. Sovleplenib NDA resubmission accepted by NMPA for 2L ITP in February 2026. Tazemetostat voluntary withdrawal by Ipsen in China in March 2026. III. 2026 LATE-STAGE CLINICAL DEVELOPMENT ACTIVITIES Savolitinib (ORPATHYS® in China), a highly selective oral inhibitor of MET Expecting topline results in H2 2026 for SAFFRON and SANOVO, following full enrollment in H2 2025: Published sub-group analysis of SACHI China Phase III study for 2L EGFRm NSCLC patients with MET amplification in The Lancet in January 2026, showing mOS of 22.9 months vs 7.9 months with chemotherapy (HR 0.32) when excluding control group patients who received subsequent MET inhibitor. Presented and published positive China Phase II pivotal study data in 3L MET-amplified GC at ASCO 2026 and in Nature Medicine in June 2026, respectively, with IRC-assessed ORR of 32.3%, mPFS of 4.0 months and mOS of 6.9 months (NCT04923932). Sovleplenib (HMPL-523), an investigative and highly selective oral inhibitor of Syk Presented positive ESLIM-02 China Phase III study data in 2L wAIHA at EHA 2026 Congress in June 2026, having met its primary endpoint of durable response rate of 66.0%, showing median time to response of 3.1 weeks and median cumulative duration of response of 16.1 weeks. Fanregratinib (HMPL-453), a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3 Presented positive China Phase II pivotal study data in 2L FGFR2 fusion/rearrangement ICC at ESMO Gastrointestinal Cancers Congress in July 2026, having met its primary endpoint of IRC-assessed ORR of 42.5%, as well as showing mPFS of 6.9 months and mOS of 16.6 months. An NDA for 2L ICC was accepted by NMPA with priority review status in December 2025 (NCT04353375). HMPL-760, a non-covalent, third generation BTK inhibitor, targeting wild-type and C481S-mutated BTK Initiated China Phase III study in combination with R-GemOx (rituximab, gemcitabine and oxaliplatin) in patients with 2L relapsed/refractory DLBCL versus placebo in combination with R-GemOx in March 2026 (NCT07409428). Primary endpoints are investigator-assessed PFS and OS. IV. ANTIBODY-DRUG CONJUGATES RESEARCH & DEVELOPMENT HMPL-A251, a first-in-class PI3K/PIKK-HER2 ATTC comprising of a highly selective and potent PI3K/PIKK inhibitor payload linked to a humanized anti-HER2 IgG1 antibody, via a cleavable linker Progressing a dose-escalation and expansion trial for unresectable, advanced or metastatic HER2-expressing solid tumors with first patient dosed in December 2025 (NCT07228247). Preclinical data showed anti-tumor activity in DXd-resistant cell line and good efficacy and safety when in combination with chemotherapy via a differentiated mechanism of action. HMPL-A580, a first-in-class PI3K/PIKK-EGFR ATTC comprising of a highly selective and potent PI3K/PIKK inhibitor payload linked to an anti-EGFR IgG1 antibody, via a cleavable linker Progressing a dose-escalation and expansion trial for solid tumors, including NSCLC, CRC, HNSCC and ESCC with first patient dosed in March 2026 (NCT07396584). Preclinical data presented at AACR 2026 showing tumor shrinkage in osimertinib-resistant EGFRm NSCLC cell line and good efficacy and safety when used in combination with osimertinib in EGFRm PAM non-altered NSCLC cell line. HMPL-A830 China/US INDs cleared Plans for global clinical trial initiation in H2 2026. Preclinical data showed superior potency and safety profiles to antibodies or small molecules with the same target, with data to be presented at a scientific conference. V. COLLABORATION UPDATES ImageneBio is developing IMG-007, a non-T cell depleting, antibody-dependent cell-mediated cytotoxicity -silenced OX40 antagonist discovered by HUTCHMED Phase IIb trial (NCT07037901) in patients with moderate-to-severe atopic dermatitis progressing, with an amended protocol and topline data anticipated in the fourth quarter of 2027. Phase II trial initiation in patients with alopecia areata expected in 2026, with initial data expected in 2028. VI. OTHER VENTURES Other Ventures consolidated revenue decreased to $116.0 million for the six months ended June 30, 2026 (H1-25: $134.2 million) which has minimal impact on profitability as the segment is predominantly low-margin prescription drug distribution business in China and HUTCHMED continues to optimize working capital management. Consolidated net income attributable to HUTCHMED from Other Ventures decreased to $3.8 million (H1-25: $24.0m), primarily due to lower equity earnings from SHPL following our 45.0% equity interest disposal in 2025. VII. SUSTAINABILITY The 2025 Sustainability Report was published in April 2026 alongside the 2025 Annual Report. We have initiated a new target-setting cycle. A list of potential focus initiatives has been identified under our five sustainability pillars: Innovation, Climate Action, Human Capital, Access to Healthcare, and Ethics and Transparency. In 2026, we will develop this into a final list, including a roadmap for achievement and monitoring. In 2026, our sustainability initiatives have continued to receive strong recognition. Most recently, our commitment was reflected in an upgraded AA rating by MSCI, recognizing HUTCHMED as a Leader, and placing us among the top 19% of pharmaceutical companies. For its second consecutive year, HUTCHMED was recognized as Most Honored Company and ranked 1st place in ESG in its sector by Extel, formerly Institutional Investor Research, in its 16th Asia Executive Team Survey. It achieved top rankings across several areas – leading CEO, CFO, Investor Relations, ESG and Corporate Governance – earning the Most Honored Company designation. HUTCHMED was the only company to earn these designations in 2026 in All Asia (ex-Mainland China) Biopharmaceuticals. FINANCIAL HIGHLIGHTS Revenue for the six months ended June 30, 2026 was $278.3 million compared to $277.7 million for the six months ended June 30, 2025. Oncology/Immunology consolidated revenue amounted to $162.3 million (H1-25: $143.5m): Other Ventures consolidated revenue of $116.0 million (H1-25: $134.2m), primarily due to scaling down low-margin logistics distribution sales after considering working capital. Net Expenses for the six months ended June 30, 2026 were $262.4 million compared to $239.0 million for the six months ended June 30, 2025. Cost of Revenue was $152.2 million (H1-25: $167.6m), predominantly due to a lower cost of sales related to the prescription drug distribution business. Cost of revenue as a percentage of oncology product revenue improved to 33% (H1-25: 39%) driven by enhanced productivity and efficiency. R&D Expenses were $78.8 million (H1-25: $72.0m) as we initiated early-stage global clinical programs for our ATTC assets and we maintain ongoing investment in discovery to deliver sustained innovation. S&A Expenses were $46.5 million (H1-25: $41.6m), driven by strong performance of our Oncology/Immunology commercial operations and enhanced productivity. Other Items generated net income of $15.1 million (H1-25: $42.2m), which mainly includes interest income and expense, foreign exchange, equity in earnings of SHPL and taxes. The decrease was mainly due to lower equity earnings from SHPL following our 45.0% equity interest disposal in 2025. Net Income attributable to HUTCHMED for the six months ended June 30, 2026 was $15.9 million compared to $455.0 million for the six months ended June 30, 2025. $0.02 basic earnings per ordinary share / $0.09 basic earnings per ADS in the first half of 2026 (H1-25: $0.53 basic earnings per ordinary share / $2.65 basic earnings per ADS). Cash, Cash Equivalents and Short-Term Investments were $1,374.8 million as of June 30, 2026 compared to $1,367.3 million as of December 31, 2025. Adjusted Group (non-GAAP) net cash inflow excluding financing activities in the first half of 2026 was $10.5 million mainly due to net income of $16.2 million less $5.6 million in capital expenditures (H1-25: net cash inflow of $519.1m mainly due to the $549.0m net proceeds from the partial divestment of SHPL less a $10.0m regulatory approval milestone payment and $9.2m in capital expenditures). Net cash used in financing activities in the first half of 2026 totaled $2.9 million mainly due to net repayments of bank borrowings (H1-25: net cash inflow of $9.3m mainly due to proceeds from bank borrowings of $8.2m). Foreign exchange impact: The RMB appreciated against the US dollar on average by approximately 5% during the first half of 2026, which has impacted consolidated financial results as highlighted. Use of Non-GAAP Financial Measures and Reconciliation – References in this announcement to adjusted Group net cash flows excluding financing activities and financial measures reported at CER are based on non-GAAP financial measures. Please see the “Use of Non-GAAP Financial Measures and Reconciliation” for further information relevant to the interpretation of these financial measures and reconciliations of these financial measures to the most comparable GAAP measures, respectively. FINANCIAL GUIDANCE HUTCHMED reiterates full year 2026 guidance for Oncology/Immunology consolidated revenue in the range of $330 million to $450 million. HUTCHMED will leverage its strong cash resources to accelerate ATTC global development and explore investment opportunities. Shareholders and investors should note that: The Company does not provide any guarantee that the statements contained in the financial guidance will materialize or that the financial results contained therein will be achieved or are likely to be achieved; and The Company has in the past revised its financial guidance and reference should be made to announcements it publishes regarding any updates to the financial guidance after the publication of this announcement. FINANCIAL SUMMARY Condensed Consolidated Balance Sheets Data Condensed Consolidated Statements of Operations Data About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, and the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: www.hutch-med.com or follow us on LinkedIn. Contacts References Unless the context requires otherwise, references in this announcement to the “Group,” the “Company,” “HUTCHMED,” “HUTCHMED Group,” “we,” “us,” and “our,” mean HUTCHMED (China) Limited and its subsidiaries unless otherwise stated or indicated by context. Past Performance and Forward-Looking Statements The performance and results of operations of the Group contained within this announcement are historical in nature, and past performance is no guarantee of future results of the Group. This announcement contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by words like “will”, “expects”, “anticipates”, “future”, “intends”, “plans”, “believes”, “estimates”, “pipeline”, “could”, “potential”, “first-in-class”, “best-in-class”, “designed to”, “objective”, “guidance”, “pursue”, or similar terms, or by express or implied discussions regarding potential drug candidates, potential indications for drug candidates or by discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that any of our drug candidates will be approved for sale in any market, that any approvals which have been obtained will continue to remain valid and effective in the future, or that the sales of products marketed or otherwise commercialized by HUTCHMED and/or its collaboration partners (collectively, “HUTCHMED’s Products”) will achieve any particular revenue or net income levels. In particular, management’s expectations could be affected by, among other things: unexpected regulatory actions or delays or government regulation generally; the uncertainties inherent in research and development, including the inability to meet our key study assumptions regarding enrollment rates, timing and availability of subjects meeting a study’s inclusion and exclusion criteria and funding requirements, changes to clinical protocols, unexpected adverse events or safety, quality or manufacturing issues; the delay or inability of a drug candidate to meet the primary or secondary endpoint of a study; the delay or inability of a drug candidate to obtain regulatory approval in different jurisdictions or the utilization, market acceptance and commercial success of HUTCHMED’s Products after obtaining regulatory approval; discovery, development and/or commercialization of competing products and drug candidates that may be superior to, or more cost effective than, HUTCHMED’s Products and drug candidates; the impact of studies (whether conducted by HUTCHMED or others and whether mandated or voluntary) or recommendations and guidelines from governmental authorities and other third parties on the commercial success of HUTCHMED’s Products and drug candidates in development; the ability of HUTCHMED to manufacture and manage supply chains, including various third party services, for multiple products and drug candidates; the availability and extent of reimbursement of HUTCHMED’s Products from third-party payers, including private payer healthcare and insurance programs and government insurance programs; the costs of developing, producing and selling HUTCHMED’s Products; the ability to obtain additional funding when needed; the ability to obtain and maintain protection of intellectual property for HUTCHMED’s Products and drug candidates; the ability of HUTCHMED to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; global trends toward health care cost containment, including ongoing pricing pressures; uncertainties regarding actual or potential legal proceedings, including, among others, actual or potential product liability litigation, litigation and investigations regarding sales and marketing practices, intellectual property disputes, and government investigations generally; and general economic and industry conditions, including uncertainties regarding the effects of the persistently weak economic and financial environment in many countries, uncertainties regarding future global exchange rates, uncertainties in global interest rates, and geopolitical relations, sanctions and tariffs. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, on AIM and on HKEX. HUTCHMED is providing the information in this announcement as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise. In addition, this announcement contains statistical data and estimates that HUTCHMED obtained from industry publications and reports generated by third-party market research firms. Although HUTCHMED believes that the publications, reports and surveys are reliable, HUTCHMED has not independently verified the data and cannot guarantee the accuracy or completeness of such data. You are cautioned not to give undue weight to this data. Such data involves risks and uncertainties and are subject to change based on various factors, including those discussed above. Inside Information This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (as it forms part of retained EU law as defined in the European Union (Withdrawal) Act 2018). Medical Information This announcement contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. This announcement in its entirety is available at: http://ml.globenewswire.com/Resource/Download/031c06fc-010c-45d1-8c53-ed93a7275b6c
Investor releaseQuarter not tagged2026-06-30HUTCHMED to Announce 2026 Half-Year Financial Results
GlobeNewswire
HUTCHMED to Announce 2026 Half-Year Financial Results
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., June 30, 2026 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; HKEX:13) will announce its interim results for the six months ended June 30, 2026 on Thursday, July 30, 2026 at 7:00 am Eastern Daylight Time (EDT) / 12:00 noon British Summer Time (BST) / 7:00 pm Hong Kong Time (HKT). HUTCHMED management will host two webcast presentations for analysts and investors to discuss the interim results, followed by Q&A sessions. The English webcast will be held on Thursday, July 30, 2026, at 8:00 am EDT / 1:00 pm BST / 8:00 pm HKT. The Chinese (Putonghua) webcast will be held at 8:30 am HKT on Friday, July 31, 2026 (1:30 am BST / 8:30 pm EDT on Thursday, July 30, 2026). Both webcasts will be available live via the company website at www.hutch-med.com/event/. The presentation will be available to download shortly before the webcast begins. A replay will also be available on the website shortly after the event. About HUTCHMED HUTCHMED (Nasdaq/AIM: HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: www.hutch-med.com or follow us on LinkedIn. CONTACTS
Investor releaseQuarter not tagged2026-03-12HUTCHMED (China) Ltd (HCM) Full Year 2025 Earnings Call Highlights: Strong Global Expansion and ...
GuruFocus.com
HUTCHMED (China) Ltd (HCM) Full Year 2025 Earnings Call Highlights: Strong Global Expansion and ...
This article first appeared on GuruFocus. Ex-China FRUZAQLA Sales Growth: 26% growth, resulting in $366 million in in-market sales. China Sales Growth: 21% in-market sales growth in the second half of the year. Cash Position: Approximately $1.4 billion. Total Oncology Revenue: $286 million, including $71 million from R&D-related upfront and milestone revenues. Net Income: $457 million, primarily due to a $416 million gain from SHPL divestment. R&D Expenses: $148 million, lower than 2024. Oncology Revenue Guidance for 2026: $330 million to $450 million. FRUZAQLA Global Expansion: Rolled out to over 38 countries. ELUNATE China Sales Growth: 33% growth in the second half of the year. ORPATHYS and SULANDA Sales: 11% of total 2025 in-market sales, facing competition. Hematology Portfolio Launch: First-in-class treatment for EZH2 mutation and follicular lymphoma approved in China. Warning! GuruFocus has detected 7 Warning Signs with HCM. Is HCM fairly valued? Test your thesis with our free DCF calculator. Release Date: March 05, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. HUTCHMED (China) Ltd (NASDAQ:HCM) reported a 26% growth in ex-China FRUZAQLA sales, reaching $366 million in in-market sales. The company has a strong cash position of approximately $1.4 billion, enabling acceleration of global ATTC development and exploration of potential in-licensing and M&A opportunities. HUTCHMED advanced two ATTC programs into the clinic, indicating significant market potential. The company recorded a profit of $457 million for 2025, largely due to a divestment gain, with core operations remaining profitable. HUTCHMED's oncology revenue guidance for 2026 is set between $330 million to $450 million, reflecting anticipated growth from new indications and continued expansion of FRUZAQLA. China sales for the brand ELUNATE posted a 13% decline in the first half of 2025 due to sales force restructuring and productivity improvement programs. ORPATHYS and SULANDA, representing 11% of total 2025 in-market sales, faced challenges due to fierce competition and limited patient pools. The U.S. market experienced headwinds due to medical Part D redesign, impacting sales. R&D expenses for 2025 were $148 million, lower than 2024, as late-stage trials are completing, but future expenses are expected to increase with new trials. Th…Read full documentShow less
This article first appeared on GuruFocus. Ex-China FRUZAQLA Sales Growth: 26% growth, resulting in $366 million in in-market sales. China Sales Growth: 21% in-market sales growth in the second half of the year. Cash Position: Approximately $1.4 billion. Total Oncology Revenue: $286 million, including $71 million from R&D-related upfront and milestone revenues. Net Income: $457 million, primarily due to a $416 million gain from SHPL divestment. R&D Expenses: $148 million, lower than 2024. Oncology Revenue Guidance for 2026: $330 million to $450 million. FRUZAQLA Global Expansion: Rolled out to over 38 countries. ELUNATE China Sales Growth: 33% growth in the second half of the year. ORPATHYS and SULANDA Sales: 11% of total 2025 in-market sales, facing competition. Hematology Portfolio Launch: First-in-class treatment for EZH2 mutation and follicular lymphoma approved in China. Warning! GuruFocus has detected 7 Warning Signs with HCM. Is HCM fairly valued? Test your thesis with our free DCF calculator. Release Date: March 05, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. HUTCHMED (China) Ltd (NASDAQ:HCM) reported a 26% growth in ex-China FRUZAQLA sales, reaching $366 million in in-market sales. The company has a strong cash position of approximately $1.4 billion, enabling acceleration of global ATTC development and exploration of potential in-licensing and M&A opportunities. HUTCHMED advanced two ATTC programs into the clinic, indicating significant market potential. The company recorded a profit of $457 million for 2025, largely due to a divestment gain, with core operations remaining profitable. HUTCHMED's oncology revenue guidance for 2026 is set between $330 million to $450 million, reflecting anticipated growth from new indications and continued expansion of FRUZAQLA. China sales for the brand ELUNATE posted a 13% decline in the first half of 2025 due to sales force restructuring and productivity improvement programs. ORPATHYS and SULANDA, representing 11% of total 2025 in-market sales, faced challenges due to fierce competition and limited patient pools. The U.S. market experienced headwinds due to medical Part D redesign, impacting sales. R&D expenses for 2025 were $148 million, lower than 2024, as late-stage trials are completing, but future expenses are expected to increase with new trials. The SAFFRON readout has been delayed from the first half to mid-2026, potentially impacting timelines for regulatory approvals. Q: Can you elaborate on the 2026 oncology guidance, given the decline in 2025 sales? A: Lorenso Chiu, Deputy CFO, explained that despite the decline in 2025, there was strong recovery in the second half. The 2026 guidance reflects expected growth from new indications, such as RCC, and continued expansion of FRUZAQLA by Takeda. Q: Why was the SAFFRON readout delayed to the second half of 2026? A: Dr. Guangxiu Dai, Head of Discovery & Global Portfolio Management, stated that the SAFFRON readout is expected in mid-2026, with no specific reason for the delay provided. Q: What is the strategy for the ATTC platform, particularly regarding partnerships? A: Johnny Cheng, Acting CEO and CFO, mentioned that HUTCHMED is open to partnering opportunities to accelerate development and validate the ATTC platform. They are considering licensing out some programs while maintaining control over others. Q: How will the changes in Medicare Part D impact U.S. sales in 2026? A: Johnny Cheng noted that the impact has been factored into 2025 results. Despite this, they achieved 26% growth in the U.S. and expect continued expansion in ex-U.S. markets. Q: How does the company plan to balance the contribution of existing commercial products with emerging opportunities from the ATTC platform? A: Johnny Cheng explained that the expansion of commercial assets will generate more income to support R&D investments, particularly in the ATTC platform, which is expected to drive future value creation. For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Investor releaseQuarter not tagged2026-03-06HUTCHMED H2 Earnings Call Highlights
MarketBeat
HUTCHMED H2 Earnings Call Highlights
FRUZAQLA showed strong overseas growth, rising 26% year-over-year to $366 million with launches in more than 38 countries, while China sales rebounded in H2 (up 21% vs H1) driven mainly by endometrial cancer reimbursement expansion. The company reported consolidated profit of $457 million, largely from a $416 million gain on a partial SPL equity divestment, with oncology revenue of $286 million (including $71 million in R&D-related upfronts) and about $1.4 billion in cash; 2026 oncology revenue guidance is $330–$450 million. R&D strategy is shifting toward an expanding ATTC platform—R&D spend fell to $148 million in 2025 but may rise toward an indicative $200–$300 million as ATTC programs (251, 580 and 830) enter and progress through global clinical development. Interested in HUTCHMED (China) Limited Sponsored ADR? Here are five stocks we like better. HUTCHMED (NASDAQ:HCM) management used its 2025 annual results call to highlight growth in global sales for FRUZAQLA, a rebound in China market performance in the second half, and increasing investment behind its ATTC (antibody-targeted therapy conjugate) platform as it advances multiple assets into clinical development. Acting CEO and CFO Johnny Zheng said the company was “very satisfied” with FRUZAQLA’s performance in overseas markets, citing a 26% year-over-year increase and market sales of $366 million. He added that FRUZAQLA has now launched in more than 38 countries. → Uber and Joby Aviation Team Up: Game Changer or Hype? On the China side, management pointed to a sharp improvement in the back half of the year. Zheng said China market sales in the second half rebounded strongly, with market sales up 21% versus the first half. Deputy CFO Lorenzo Zhao reported total 2025 oncology business revenue of $286 million, which included $71 million of R&D-related upfront payments, milestones, and service income. He reiterated the second-half rebound in domestic oncology product performance and continued overseas expansion for FRUZAQLA. → BigBear.ai Stock Is Down Big, But Smart Money Is Quietly Buying Zhao said consolidated profit reached $457 million, which he attributed primarily to a $416 million gain from divesting part of the company’s SPL equity interest. He added that even without the transaction-related gain, the company’s core business remained profitable. R&D spending was $148 million in 2025, down from 2024…Read full documentShow less
FRUZAQLA showed strong overseas growth, rising 26% year-over-year to $366 million with launches in more than 38 countries, while China sales rebounded in H2 (up 21% vs H1) driven mainly by endometrial cancer reimbursement expansion. The company reported consolidated profit of $457 million, largely from a $416 million gain on a partial SPL equity divestment, with oncology revenue of $286 million (including $71 million in R&D-related upfronts) and about $1.4 billion in cash; 2026 oncology revenue guidance is $330–$450 million. R&D strategy is shifting toward an expanding ATTC platform—R&D spend fell to $148 million in 2025 but may rise toward an indicative $200–$300 million as ATTC programs (251, 580 and 830) enter and progress through global clinical development. Interested in HUTCHMED (China) Limited Sponsored ADR? Here are five stocks we like better. HUTCHMED (NASDAQ:HCM) management used its 2025 annual results call to highlight growth in global sales for FRUZAQLA, a rebound in China market performance in the second half, and increasing investment behind its ATTC (antibody-targeted therapy conjugate) platform as it advances multiple assets into clinical development. Acting CEO and CFO Johnny Zheng said the company was “very satisfied” with FRUZAQLA’s performance in overseas markets, citing a 26% year-over-year increase and market sales of $366 million. He added that FRUZAQLA has now launched in more than 38 countries. → Uber and Joby Aviation Team Up: Game Changer or Hype? On the China side, management pointed to a sharp improvement in the back half of the year. Zheng said China market sales in the second half rebounded strongly, with market sales up 21% versus the first half. Deputy CFO Lorenzo Zhao reported total 2025 oncology business revenue of $286 million, which included $71 million of R&D-related upfront payments, milestones, and service income. He reiterated the second-half rebound in domestic oncology product performance and continued overseas expansion for FRUZAQLA. → BigBear.ai Stock Is Down Big, But Smart Money Is Quietly Buying Zhao said consolidated profit reached $457 million, which he attributed primarily to a $416 million gain from divesting part of the company’s SPL equity interest. He added that even without the transaction-related gain, the company’s core business remained profitable. R&D spending was $148 million in 2025, down from 2024. Zhao attributed the decline to some high-cost registration clinical trials moving into later stages, several new drug approvals under review, and a shift of resources toward ATTC programs, including two new products that have entered clinical trials. → Archer Aviation Stock Tanks—The Real Story Is What Wall Street Overlooked Management also emphasized cash resources. Zheng said the company had about $1.4 billion in cash reserves, which he described as supporting accelerated global development of ATTC programs and providing capacity to pursue in-licensing and M&A opportunities. For 2026, Zhao provided oncology business revenue guidance of $330 million to $450 million, describing it as steady growth from 2025. Management said key drivers include stronger domestic oncology product growth under new administrative initiatives, continued overseas expansion for FRUZAQLA, and potential new partnering opportunities related to ATTC and other pipeline candidates. In the Q&A, Zhao said the company did not provide formal guidance for R&D expense. However, he indicated spending could rise as ATTC development progresses, potentially returning toward 2024 levels over time and ultimately reaching a range of about $200 million to $300 million, which he framed as an indicative range rather than official guidance. Commercial lead George Yuan discussed FRUZAQLA’s performance under partner Takeda internationally, again citing 26% growth and $366 million in sales in Takeda territories, driven by new market launches and accelerating second-half growth. Yuan highlighted strong performance in Japan and reimbursement expansion in some EU countries, while noting that changes in U.S. federal medical insurance created headwinds consistent with broader industry impacts. In China, Yuan said the business had faced a “-13” performance previously, which he attributed to the failure of a late-stage prostate cancer indication (referred to on the call as not being approved), which in turn required salesforce and structural adjustments. He said the company carried out reorganization and productivity initiatives, contributing to weaker first-half performance, but that the business “successfully reversed” the situation in the second half with strong growth. Yuan said the company successfully renewed national reimbursement and added a second-line endometrial cancer indication into reimbursement while maintaining price. He also noted an RCC second-line indication submission and said these steps create a platform for continued growth into 2026. He also addressed other products, stating that ORPATHYS and SUTENT represented about 11% of the company’s broader commercial portfolio and faced intensified competition during the year. Despite that, Yuan cited several items he said could support future growth for savolitinib, including reimbursement coverage for first-line MET exon 14 skipping and approval in China for the SACHI indication (EGFR-mutant resistant patients with MET amplification). For SUTENT, he said the company continues to see room for growth in neuroendocrine tumors, citing opportunity to improve disease awareness and diagnosis rates, and said reimbursement was successfully renewed through 2026. He added that a Phase 3 registration study in pancreatic cancer is progressing normally. In response to an analyst question on domestic FRUZAQLA growth, Yuan said the second-half increase was driven mainly by endometrial cancer rather than colorectal cancer, noting that endometrial cancer had not previously been included in reimbursement, limiting its earlier contribution. R&D head Dave (Guangshu) reviewed regulatory and clinical progress across oncology, hematology, and the ATTC platform. In oncology, he said savolitinib reached key registration and clinical milestones in China and globally. He said SACHI was approved in China for second-line EGFR-mutant MET-amplified NSCLC, and that the SONOVA (China Phase 3) and SAPHIR (global multicenter Phase 3) studies completed Phase 3 enrollment in 2025. He added that an NDA for third-line gastric cancer in China had been submitted and accepted with priority review. Dave also discussed published and presented data for SACHI, including results he said were published in The Lancet in 2026. He stated that in patients who had not received subsequent MET inhibitors, overall survival improved from 7.9 months to 22.9 months with the savolitinib and osimertinib combination versus chemotherapy. He also cited ASCO 2025 disclosures indicating improvements in ORR and DOR and a statistically and clinically meaningful improvement in PFS. In hematology, Dave said the company resubmitted an NDA in China for sovleplenib (HMPL-523) in ITP in February 2026 and received breakthrough therapy and priority review designations. He highlighted three-year follow-up data presented at ASH 2025, including an average drug exposure duration of more than 86 weeks, cumulative durable response time over 66 weeks, and 51.4% of patients achieving long-term sustained remission under the criteria described on the call. He emphasized safety differentiation versus TPO/TPO-R agonists, particularly around thrombotic risk. Dave also described the market opportunity in ITP, stating that in China about 250,000 ITP patients are actively receiving treatment and that the potential market value was estimated at $500 million to $700 million. On ATTC, Dave said the platform has entered clinical-stage development. He said two ATTC products—251 and 580—are in global clinical development: 251 began recruiting patients in China and the U.S. in December 2025, and 580 enrolled its first patient just days before the call. He also said a third ATTC product, 830, is expected to enter global Phase 1 in the second half of the year. He described 251 as a first-in-class ATTC that conjugates a high-potency PI3K/PIKK inhibitor payload to a HER2 antibody and outlined preclinical characteristics including HER2-dependent activity and a bystander effect. Looking ahead, management outlined several expected milestones over roughly the next 15 months, including Phase 3 results for the global SAFFRON study in mid-2026 and an NDA submission by year-end, top-line results from the CINOVA study in the second half of the year or early the following year, and the potential launch in 2026 for savolitinib in third-line gastric cancer. Dave also said the company expects three ATTC products to be in global clinical development during 2026. During Q&A, management said it is seeking overseas development partners for sovleplenib and may pursue opportunities such as orphan drug designation to extend exclusivity and maximize overseas commercial value. On commercialization preparation in China, Yuan said the company expects to cover roughly 400 to 500 core target hospitals for hematology products and aims to build a specialized hematology sales team of about 100 representatives in the second half of the year. Finally, management said it currently has no plans for share buybacks or dividends, and intends to prioritize cash deployment toward accelerating global ATTC R&D and evaluating in-licensing and M&A opportunities. HUTCHMED (NASDAQ: HCM) is a fully integrated biopharmaceutical company focused on discovering, developing, manufacturing and commercializing targeted therapies and immunotherapies for the treatment of cancer and other diseases. The company leverages in-house capabilities in small-molecule chemistry, biologics engineering and translational medicine to advance candidates through all stages of development. HUTCHMED's integrated model encompasses early discovery research, clinical development, regulatory filings and commercial launches, enabling seamless progression from laboratory to market. HUTCHMED's commercial portfolio includes several in-market oncology therapies approved in China, including fruquintinib for metastatic colorectal cancer, surufatinib for neuroendocrine tumors and savolitinib for non-small cell lung cancer. The article "HUTCHMED H2 Earnings Call Highlights" was originally published by MarketBeat.
Investor releaseQuarter not tagged2026-03-05HUTCHMED Reports 2025 Full Year Results and Business Updates
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HUTCHMED Reports 2025 Full Year Results and Business Updates
— Geographic expansion driving ex-China sales growth; indication expansions driving China sales growth — — $457 million net income, driven by profitable core operations and non-core disposal — — Rapidly progressing groundbreaking ATTC technology, a source of novel drug candidates with broad therapeutic potential — — Pursuing potential opportunities for partnering ATTC candidates with multinational pharmaceutical companies — HONG KONG and SHANGHAI and FLORHAM PARK, N.J. , March 05, 2026 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”, the “Company” or “we”) (Nasdaq/AIM:HCM; HKEX:13) today reports its financial results for the year ended December 31, 2025 and provides updates on key clinical and commercial developments. HUTCHMED to host results webcasts at 8:00 a.m. EST / 1:00 p.m. GMT / 9:00 p.m. HKT in English on Thursday, March 5, 2026, and tomorrow at 8:30 a.m. HKT in Chinese (Putonghua) on Friday, March 6, 2026. After registration, investors may access the live webcast at www.hutch-med.com/event. All amounts are expressed in US dollars unless otherwise stated. A glossary of abbreviations is on page 29. Global commercial progress, delivery of sustainable growth and robust balance sheet FRUZAQLA® (fruquintinib ex-China) in-market sales by Takeda were up 26% to $366.2 million (2024: $290.6m), propelled by successful launches, and additional reimbursement coverage, driven by need for novel non-chemotherapy treatments in CRC and ongoing positive experiences of oncologists in 3L+. ELUNATE® (fruquintinib in China) in-market sales were $100.1 million (2024: $115.0m), with strong growth in H2 (H2 up 33% vs. H1). ORPATHYS® (savolitinib) triggered an $11.0 million milestone payment from AstraZeneca for securing China approval for its third lung cancer indication. Net income attributable to HUTCHMED of $456.9 million (2024: $37.7m), with a cash balance of $1.4 billion at year end, boosted by a $415.8 million divestment gain net of tax. Antibody-Targeted Therapy Conjugate (“ATTC”) platform advances into clinical trials, paving the way for a rich pipeline of new drug candidates entering the clinic Initiated first clinical trial on first ATTC drug candidate HMPL-A251 in December 2025, quickly following its pre-clinical data presentation at AACR-NCI-EORTC Conference in October 2025. Next ATTC drug candidates entered clinical trials, with the HMPL-A580 trial init…Read full documentShow less
— Geographic expansion driving ex-China sales growth; indication expansions driving China sales growth — — $457 million net income, driven by profitable core operations and non-core disposal — — Rapidly progressing groundbreaking ATTC technology, a source of novel drug candidates with broad therapeutic potential — — Pursuing potential opportunities for partnering ATTC candidates with multinational pharmaceutical companies — HONG KONG and SHANGHAI and FLORHAM PARK, N.J. , March 05, 2026 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”, the “Company” or “we”) (Nasdaq/AIM:HCM; HKEX:13) today reports its financial results for the year ended December 31, 2025 and provides updates on key clinical and commercial developments. HUTCHMED to host results webcasts at 8:00 a.m. EST / 1:00 p.m. GMT / 9:00 p.m. HKT in English on Thursday, March 5, 2026, and tomorrow at 8:30 a.m. HKT in Chinese (Putonghua) on Friday, March 6, 2026. After registration, investors may access the live webcast at www.hutch-med.com/event. All amounts are expressed in US dollars unless otherwise stated. A glossary of abbreviations is on page 29. Global commercial progress, delivery of sustainable growth and robust balance sheet FRUZAQLA® (fruquintinib ex-China) in-market sales by Takeda were up 26% to $366.2 million (2024: $290.6m), propelled by successful launches, and additional reimbursement coverage, driven by need for novel non-chemotherapy treatments in CRC and ongoing positive experiences of oncologists in 3L+. ELUNATE® (fruquintinib in China) in-market sales were $100.1 million (2024: $115.0m), with strong growth in H2 (H2 up 33% vs. H1). ORPATHYS® (savolitinib) triggered an $11.0 million milestone payment from AstraZeneca for securing China approval for its third lung cancer indication. Net income attributable to HUTCHMED of $456.9 million (2024: $37.7m), with a cash balance of $1.4 billion at year end, boosted by a $415.8 million divestment gain net of tax. Antibody-Targeted Therapy Conjugate (“ATTC”) platform advances into clinical trials, paving the way for a rich pipeline of new drug candidates entering the clinic Initiated first clinical trial on first ATTC drug candidate HMPL-A251 in December 2025, quickly following its pre-clinical data presentation at AACR-NCI-EORTC Conference in October 2025. Next ATTC drug candidates entered clinical trials, with the HMPL-A580 trial initiated in March 2026, and the third candidate HMPL-A830 aiming to begin Phase I by year end. Pursuing potential opportunities for partnering ATTC drug candidates with multinational pharmaceutical companies in 2026. Pipeline progress as planned across late-stage clinical portfolio Positive FRUSICA-2 Phase III (leading to NMPA sNDA acceptance) and PDAC Phase II results presented at ESMO and ESMO Asia. ELUNATE® with sintilimab in 2L kidney cancer achieved mPFS of 22.2 vs. 6.9 months with axitinib/everolimus. SULANDA®-based combination in 1L metastatic PDAC also showed significant mPFS improvement and an OS benefit trend (data immature), leading to Phase III initiation. Positive ESLIM-02 Phase III wAIHA results for sovleplenib meeting primary endpoint of durable response rate within 24 weeks. ITP NDA was accepted by the NMPA in February 2026 and wAIHA filing is planned in H1 2026. ESLIM-01 updated results at ASH showed maximum duration of response of 25.9 weeks with median duration of exposure of around 20 months under a tolerable safety profile. According to IQVIA, ITP has 41,000 new patients every year, on top of another 430,000 existing patients, while wAIHA adds another 26,000 per year in China. SACHI China and SAVANNAH global lung cancer trials of ORPATHYS® combined with TAGRISSO® presented at ASCO and ELCC conferences, with the data supporting approvals in China and Switzerland, respectively. Enrollments completed for SAFFRON global and SANOVO China Phase III trials with readouts expected within next 12 months. Dr Dan Eldar, Non-executive Chairman of HUTCHMED, said, “Our team’s expertise in the science of creating novel medicines, enhanced by advanced AI tools, positions HUTCHMED as a leader in advancing new modalities. Leveraging this leadership, we actively continue to explore new technologies, assets and targets to complement our portfolio, ready to make good use of our strong balance sheet. Our Business Development team has encountered interest from multinational pharmaceutical companies to cooperate on the development and launch of novel drug candidates with potential to become global market leaders. Any such potential partnerships would further validate the scientific and commercial value of our new platforms, whilst allowing HUTCHMED to leverage the multinational partners’ advantages regarding global development and marketing expertise to accelerate its novel medicines to address large unmet needs around the world. This strategy has been successfully demonstrated with FRUZAQLA® and will be applied to our ATTC technology, which is expected to bear its first fruits this year. Our company is at a pivotal point. We have repositioned our commercial team to better meet challenges in our environment and to spur sales growth in China, delivering significant improvements from the second quarter of 2025. With late-stage programs, we have demonstrated impressive clinical results in Phase III trials leading to NDA filings, and we have proven experience in gaining approval with major regulatory authorities. Moreover, our large molecule technology platforms have graduated from novel drug discovery into clinical development, with two such drug candidates so far. We see this as a golden opportunity for HUTCHMED to not just work alongside with world leaders in the field, but also to increase our R&D investment and expedite the broad therapeutic potential of our platforms.” Mr Johnny Cheng, Acting Chief Executive Officer and Chief Financial Officer of HUTCHMED, said, “2025 has been challenging and we have implemented changes to adjust dynamically our commercial operations. Our sales team has been streamlined and is now well positioned to support growth of our key drugs, with improving sales during the second half of the year. This is all part of ensuring we have a sustainable operation that is ready for the future, where strong earnings from our commercial products drive the development of an exciting pipeline. Our next wave of products, such as sovleplenib and fanregratinib, are currently under regulatory review, strengthening sales and earnings visibility of next few years. Our strong balance sheet with $1.4 billion in cash helps support expeditious development of our ATTC technology platform and its novel drug candidates. 2025 was the third consecutive year of profits for HUTCHMED and we aim to remain financially self-sufficient in discovering and developing more innovative assets into clinical phase.” Dr Weiguo Su, Chief Executive Officer (currently on leave of absence) and Chief Scientific Officer of HUTCHMED, said, “We are in a new era of innovative drug development where both speed and quality are more crucial than ever. The HUTCHMED team has consistently risen to this challenge and the past year has been no exception. The late-stage clinical pipeline continues to progress and excite us, whilst our prolific drug discovery engine also continues at pace. We are particularly enthusiastic about the potential of our ATTC platform, originated by our scientists to combine the potency of small-molecule targeted therapy with the selectivity of antibodies. This approach leverages our over 20 years of hard work developing novel, efficacious medicines with better safety profiles, allowing optimum dosing and duration of treatment. We presented preclinical data on our first ATTC candidate at a major conference in October, obtained IND approval in China and the US in November, and dosed our first patient in December. Our team is well equipped with deep knowledge in drug development and experience in gaining approval for quality products around the world.” 2025 FULL YEAR RESULTS & BUSINESS UPDATES I. COMMERCIAL OPERATIONS Total in-market sales, including FRUZAQLA®, ELUNATE®, SULANDA® and ORPATHYS®, of $524.7 million achieved growth in 2025 of 5% despite regulatory and commercial headwinds in the first half of 2025. Our performance in the second half of 2025 represents a significant inflection point with 24% growth of in-market sales compared to first half of 2025 as we begin to see the benefits of repositioning our commercial team to support continued growth. FRUZAQLA® in-market sales by Takeda were up 26% in 2025 at $366.2 million, driven by strong growth following approvals in 38 countries to date, including over 15 in 2025. Recent growth was primarily due to continued launches across Europe, Asia and the Americas (late 2025 launches included Portugal, Belgium, South Korea and Mexico), as it addresses a need for new colorectal cancer treatments. Subsequent reimbursement is also progressing, with availability to date in almost 20 countries, which led to strong uptake, most recently seen following the UK NICE recommendation. The increase was partially offset by the sales impact of the US Medicare Part D Redesign that affected many prescription medicines in 2025. FRUZAQLA® stands out with its overall safety profile and low pill burden, alongside attractive efficacy data. Total consolidated revenue for oncology products decreased 21% to $214.4 million as compared to 2024, primarily due to a $20 million commercial milestone payment from Takeda recognized in 2024 and lower sales in China for ELUNATE®, SULANDA®, and ORPATHYS® due to the aforementioned headwinds. As with in-market sales, oncology product revenue in China have reached a similar inflection point with sales growth of 23% in the second half of 2025 compared to the first half. Other Oncology/Immunology revenue, consisting of upfront, regulatory milestones, R&D services and licensing revenue was $71.1 million. Other Ventures revenue, mainly from prescription drug distribution, remained flat at $263.0 million, leading to total consolidated revenue of $548.5 million. * FRUZAQLA®, ELUNATE® and ORPATHYS® mainly represent total sales to third parties as provided by Takeda, Eli Lilly and AstraZeneca, respectively. ** FRUZAQLA® represents manufacturing revenue, royalties and commercial milestone paid by Takeda to HUTCHMED; ELUNATE® represents manufacturing revenue, promotion and marketing services revenue and royalties paid by Eli Lilly to HUTCHMED, and sales to other third parties invoiced by HUTCHMED; ORPATHYS® represents manufacturing revenue and royalties paid by AstraZeneca to HUTCHMED and sales to other third parties invoiced by HUTCHMED; SULANDA® and TAZVERIK® represent HUTCHMED’s sales of the products to third parties. II. 2025 REGULATORY UPDATES Savolitinib MAA approved (temporary authorization) by Swissmedic combined with TAGRISSO® for 2L EGFRm NSCLC with MET amplification and/or overexpression in February 2026. Savolitinib sNDA accepted by NMPA with priority review for 3L GC with MET amplification in December. Savolitinib sNDA approved by NMPA combined with TAGRISSO® for 2L EGFRm NSCLC with MET amplification in June, triggering $11.0 million milestone from AstraZeneca. Savolitinib sNDA approved by NMPA for 1L and 2L (converted from conditional to full approval) METex14 NSCLC in January, and approved in Hong Kong for under the 1+ Mechanism in February. Fanregratinib NDA accepted by NMPA with priority review in 2L IHCC in December. Fruquintinib sNDA accepted by NMPA combined with sintilimab for 2L renal cell carcinoma in June. Tazemetostat NDA conditionally approved by NMPA for 3L R/R follicular lymphoma with EZH2 mutation in March. III. LATE-STAGE CLINICAL DEVELOPMENT ACTIVITIES Savolitinib (ORPATHYS® in China), a highly selective oral inhibitor of MET Published SACHI China Phase III results in The Lancet after presentation at ASCO 2025 for 2L EGFRm NSCLC patients with MET amplification, in combination with TAGRISSO®, showing mPFS of 8.2 months compared to 4.5 months with chemotherapy in ITT population (HR 0.34), and 6.9 months compared to 3.0 months in post third-generation EGFR TKI-treated subgroup (HR 0.32, both p<0.0001) (NCT05015608). Presented SAVANNAH global Phase II results at ELCC 2025 for 2L EGFRm NSCLC patients with MET amplification or overexpression, in combination with TAGRISSO®, showing ORR of 56%, mPFS of 7.4 months and mDoR of 7.1 months (NCT03778229). Completed enrollment of SAFFRON global Phase III study for 2L EGFRm NSCLC patients with MET amplification or overexpression (NCT05261399); and completed enrollment of SANOVO China Phase III study for 1L EGFRm NSCLC patients with MET overexpression (NCT05009836). SAFFRON topline results expected in H2 2026, which could support global filings. SANOVO topline results expected in late 2026 or early 2027. Achieved positive data in Phase ІІ 3L gastric cancer registration cohort for MET-amplified patients, supporting the China NDA (NCT04923932). Fruquintinib (ELUNATE® in China, FRUZAQLA® outside of China), a highly selective oral inhibitor of VEGFR Presented FRUSICA-2 registration Phase III results at ESMO 2025 for 2L RCC, in combination with TYVYT® achieving mPFS of 22.2 months versus 6.9 months with axitinib/everolimus (HR 0.373; p<0.0001), and ORR of 60.5% vs 24.3%, with mDoR of 23.7 vs 11.3 months (NCT05522231). Sovleplenib (HMPL-523), an investigative and highly selective oral inhibitor of Syk Achieved positive results in Phase III part of ESLIM-02 trial for warm AIHA in China in January 2026, having met its primary endpoint of durable response rate within 24 weeks of treatment. A sNDA submission to the NMPA is planned in the first half of 2026 (NCT05535933). Resubmitted NDA for ESLIM-01 ITP with additional stability studies in February 2026, to meet NMPA stipulation of a lower impurity limit. Rolling data planned to be submitted in the second half of 2026. The company is pursuing potential partnership to continue overseas development. Surufatinib (SULANDA® in China), an oral inhibitor of VEGFR, FGFR and CSF-1R Presented Phase II part results of a China Phase II/III for 1L metastatic PDAC patients at ESMO Asia, combined with camrelizumab, nab-paclitaxel and gemcitabine, achieving mPFS of 7.2 months vs 5.5 months with nab-paclitaxel and gemcitabine alone (HR 0.499; p=0.0407), and ORR of 67.7% vs 41.9%. Initiated Phase III part in December 2025 (NCT06361888). Tazemetostat (TAZVERIK® in China), a first-in-class, oral inhibitor of EZH2 Continued enrolling SYMPHONY-1 China portion of the Phase III portion of the global study, in combination with lenalidomide and rituximab, in 2L follicular lymphoma patients (NCT04224493). Fanregratinib (HMPL-453), a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3 Positive Phase II registration study data supporting NDA accepted by the NMPA with priority review for IHCC with FGFR2 fusion/rearrangement in December 2025 (NCT04353375). IV. ANTIBODY-DRUG CONJUGATES RESEARCH & DEVELOPMENT HUTCHMED has developed its comprehensive Antibody-targeted therapy conjugates (ATTCs) platform, next-generation solutions for small-molecule inhibitor payloads conjugated to monoclonal antibodies to deliver dual mechanisms of action, designed to meet critical medical needs. Each unique payload has broad potential to lead to a family of antibody conjugate drug candidates from this platform. HMPL-A251, a first-in-class PI3K/PIKK-HER2 ATTC comprising of a highly selective and potent PI3K/PIKK inhibitor payload linked to a humanized anti-HER2 IgG1 antibody, via a cleavable linker First ATTC drug candidate, based on our PI3K/PIKK inhibitor payload to address the significant challenges faced in targeting this pathway, including on-target toxicities that restrict dosing and feedback loops that enable pathway reactivation. PI3K/PIKK inhibitor payload ATTCs are designed to enhance targeted delivery directly to tumor cells, maximizing therapeutic benefit while minimizing systemic exposure. Presented preclinical data at AACR-NCI-EORTC in October 2025, showing robust antitumor activity with synergistic and bystander killing effects, including compared to co-administration of antibody and payload. Initiated global Phase I/IIa trial in December 2025, evaluating HMPL-A251 in adult patients with unresectable, advanced or metastatic HER2-expressing solid tumors, with sites in the US and China. HMPL-A580, a first-in-class PI3K/PIKK-EGFR ATTC comprising of a PI3K/PIKK inhibitor payload linked to a humanized anti-EGFR IgG1 antibody, via a cleavable linker Second ATTC based on the PI3K/PIKK inhibitor payload. EGFR is a well-recognized driver in tumor formation and disease progression. Modulation of the PI3K/AKT/mTOR pathway is required for EGFR-mediated tumorigenesis or resistance to EGFR-targeted therapy. Preclinical data have shown that PAM pathway inhibition synergizes with anti-EGFR therapy to enhance anti-tumor activity, and will be presented at an upcoming scientific conference. Initiated global trial in March 2026, evaluating in EGFR solid tumors, with US and China sites. Further preclinical progress with antibody drug conjugates Progressed ATTC drug candidate HMPL-A830, with plans for global IND filings and clinical trial initiations in 2026. V. COLLABORATION UPDATES Further progress with ImageneBio on drug candidate IMG-007, discovered by HUTCHMED HUTCHMED holds approximately 3.8% of ImageneBio, which has the rights to and is developing IMG-007. Initiated ADAPTIVE Phase IIb trial for moderate-to-severe atopic dermatitis, a randomized, placebo-controlled dose-finding study in approximately 220 patients (NCT07037901). Presented at ISDS positive results from the US/Canada Phase IIa study, showing rapid onset and durable clinical activity after four weeks, well tolerated safety profile without pyrexia or chills, and an extended half-life (NCT05984784). Presented positive results of a US/Canada Phase IIa trial for severe alopecia areata at ISDS, showing clinical signal of hair regrowth, progressive reduction in scalp hair loss without plateauing by week 36, partial restoration of hair keratins in the scalp, and a well-tolerated safety profile (NCT06060977). VI. OTHER VENTURES Other Ventures consolidated revenue, predominantly from the prescription drug distribution business in China, were steady at $263.0 million. HUTCHMED divested a 45.0% equity interest in SHPL for $608.5 million in cash in April 2025, retaining a 5.0% equity interest. As a result, HUTCHMED’s share of equity in earnings of SHPL in 2025 decreased to $24.6 million. Consolidated net income attributable to HUTCHMED from Other Ventures decreased to $25.5 million (2024: $47.7m), primarily due to the equity interest disposal in SHPL. VII. SUSTAINABILITY The 2025 Sustainability Report will be published in April 2026 alongside the 2025 Annual Report, showcasing our achievements across 11 goals and targets. We have initiated a new target-setting cycle, engaging with the various business units. A list of potential focus initiatives has been identified under our five sustainability pillars: Innovation, Climate Action, Human Capital, Access to Healthcare, and Ethics and Transparency. In 2026 we will develop this into a final list, including a detailed roadmap for achievement and monitoring. In 2024 and 2025, the Company conducted a thorough climate risks financial impact assessment, focusing on both physical risks, particularly flood risks and heat stress; and transition risks, such as policy changes. In response to the risks and opportunities identified, we developed targeted mitigation measures to address potential damage and business interruptions. Our transition planning is integrated with the new targets planning, ensuring effective management of risks while capitalizing on the opportunities outlined in the assessments. Throughout 2025, our sustainability initiatives garnered significant recognition, resulting in 10 prestigious awards from leading industry organizations and consistently strong performance in major ESG ratings. Notably, we were honored as an ESG Leading Enterprise for a third consecutive year and received accolades for Leading Environmental Initiatives and Leading Social Initiatives from Bloomberg Businessweek. Our commitment is reflected in our maintained A ratings from both MSCI and Wind, and A- rating from Hang Seng Corporate Sustainability; our upgrade to B- Prime (top decile rank) from ISS; and ESG Risk rating score further reduced to 21.9 (10th percentile, lower is better) by Sustainalytics. Additionally, we were included in the S&P Global Sustainability Yearbook 2025 as one of the top industry performers. Our efforts were further validated as we ranked third in ESG Excellence in Extel’s Asia Executive Team Survey, based on feedback from over 5,400 portfolio managers and analysts. FINANCIAL HIGHLIGHTS Revenue for the year ended December 31, 2025 was $548.5 million compared to $630.2 million for the year ended December 31, 2024. Oncology/Immunology consolidated revenue amounted to $285.5 million (2024: $363.4m): FRUZAQLA® revenue was $89.4 million (2024: $110.8m), impacted primarily due to $20 million commercial payment recognized from Takeda in 2024. In-market sales by Takeda were $366.2 million (up 26%) driven by strong growth following approvals in 38 countries to date, including over 15 in 2025. ELUNATE® revenue was $76.9 million (2024: $86.3m), which reflects our initiatives to enhance controls over commercial operations to align with the evolving regulatory landscape and uphold the highest compliance standards. We also streamlined our sales force to build a more efficient commercial organization and to enhance productivity. These initiatives only temporarily weighed on performance, with revenue growth of 29% in the second half of 2025 compared to the first half. This recovery was supported by refocusing on top-tier hospitals and high-potential provinces to maintain our leading market share position in 3L mCRC, and the contribution from the EMC indication that successfully broadened the addressable patient population for ELUNATE®. SULANDA® revenue was $27.0 million (2024: $49.0m), which reflects competition from new NRDL entries. In response, we have transformed our marketing strategies which allowed us to maintain the leading position of SULANDA® in the NET TKI market and stabilize sales in the second half of 2025 (H2 up 13% vs H1 2025). ORPATHYS® revenue was $18.6 million (2024: $24.5m), impacted by strong competition in the METex14 skipping NSCLC setting. However, sales stabilized in the second half of 2025 as AstraZeneca continues its efforts to increase MET testing as the standard-of-care for late-stage NSCLC. TAZVERIK® revenue was $2.5 million (2024: $0.9m) with increased sales in mainland China since July 2025 following its approval in March 2025. Takeda upfront, regulatory milestones and R&D services revenue were $51.6 million (2024: $67.0m), due to less R&D and regulatory support services since FRUZAQLA® is now fully launched. Other revenue of $19.5 million (2024: $24.9m), includes $8.5 million (2024: $13.9m) cost reimbursement from partners, which decreased as trials advanced into later stage of development, and a regulatory milestone of $11.0 million from AstraZeneca following China NDA approval for SACHI. Other Ventures consolidated revenue of $263.0 million (2024: $266.8m) remained flat. Net Expenses for the year ended December 31, 2025 were $507.4 million compared to $592.5 million for the year ended December 31, 2024, reflecting prioritization of R&D and disciplined cost management. Cost of Revenue was $336.3 million (2024: $348.9m), generally aligned with lower Oncology/Immunology revenue. Cost of revenue as a percentage of oncology product revenue remained stable at 39% (2024: 34%). R&D Expenses were $148.3 million (2024: $212.1m) as we complete higher costs late-stage trials for our assets which have led to NDA applications and approvals. As a result, China and US R&D spending reduced by $36.2 million and $27.6 million, respectively. Nevertheless, we maintain and are committed to ongoing investment in discovery to deliver sustained innovation and have plans to accelerate investment in the global clinical trials of our earlier-stage ATTC programs. S&A Expenses were $103.0 million (2024: $112.9m). The decrease was mainly due to a reduction in S&A expenses for oncology products which was $33.8 million or 15.8% of oncology product revenue (2024: $45.1m or 16.6%). This efficiency improvement highlights the successful streamlining of the sales force structure and the implementation of spending controls. Other Items generated net income of $80.2 million (2024: $81.4m), which mainly includes interest income and expense, foreign exchange, equity in earnings of SHPL and taxes. Gain on divestment of SHPL, net of tax was $415.8 million for the year ended December 31, 2025. Net Income attributable to HUTCHMED for the year ended December 31, 2025 was $456.9 million compared to $37.7 million for the year ended December 31, 2024. $0.53 basic earnings per ordinary share / $2.66 basic earnings per ADS in 2025 (2024: $0.04 basic earnings per ordinary share / $0.22 basic earnings per ADS). Cash, Cash Equivalents and Short-Term Investments were $1,367.3 million as of December 31, 2025 compared to $836.1 million as of December 31, 2024. Adjusted Group (non-GAAP) net cash inflows excluding financing activities in 2025 were $523.3 million mainly due to the receipt of $608.5 million gross proceeds from the partial divestment of SHPL offset by a related $59.5 million capital gain tax payment; $10.0 million regulatory approval milestone payment; and $14.1 million in capital expenditures (2024: net cash outflow of $19.5m mainly due to $17.9m of capital expenditures). Net cash generated from financing activities in 2025 totaled $7.8 million mainly due to $6.3 million net amount drawn from bank borrowings (2024: net cash outflow of $30.7m mainly due to purchases for equity awards of $36.1m). Foreign exchange impact: The RMB appreciated against the US dollar on average by approximately 0.4% during 2025, which has impacted consolidated financial results as highlighted. Use of Non-GAAP Financial Measures and Reconciliation – References in this announcement to adjusted Group net cash flows excluding financing activities and financial measures reported at CER are based on non-GAAP financial measures. Please see the “Use of Non-GAAP Financial Measures and Reconciliation” for further information relevant to the interpretation of these financial measures and reconciliations of these financial measures to the most comparable GAAP measures, respectively. Financial Statements – HUTCHMED will today file with the US Securities and Exchange Commission its Annual Report on Form 20-F. FINANCIAL GUIDANCE HUTCHMED provides full year 2026 guidance for Oncology/Immunology consolidated revenue in the range of $330 million to $450 million. This guidance reflects continued growth momentum of HUTCHMED’s China commercial operations, ongoing global commercial expansion of FRUZAQLA®, and new partnership opportunities for novel drug candidates. HUTCHMED will leverage its strong cash resources to accelerate ATTC global development and explore investment opportunities. Shareholders and investors should note that: The Company does not provide any guarantee that the statements contained in the financial guidance will materialize or that the financial results contained therein will be achieved or are likely to be achieved; and The Company has in the past revised its financial guidance and reference should be made to announcements it publishes regarding any updates to the financial guidance after the publication of this announcement. FINANCIAL SUMMARY Condensed Consolidated Balance Sheets Data Condensed Consolidated Statements of Operations Data About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, and the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: www.hutch-med.com or follow us on LinkedIn. Contacts References Unless the context requires otherwise, references in this announcement to the “Group,” the “Company,” “HUTCHMED,” “HUTCHMED Group,” “we,” “us,” and “our,” mean HUTCHMED (China) Limited and its subsidiaries unless otherwise stated or indicated by context. Past Performance and Forward-Looking Statements The performance and results of operations of the Group contained within this announcement are historical in nature, and past performance is no guarantee of future results of the Group. This announcement contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by words like “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “pipeline,” “could,” “potential,” “first-in-class,” “best-in-class,” “designed to,” “objective,” “guidance,” “pursue,” or similar terms, or by express or implied discussions regarding potential drug candidates, potential indications for drug candidates or by discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that any of our drug candidates will be approved for sale in any market, that any approvals which have been obtained will continue to remain valid and effective in the future, or that the sales of products marketed or otherwise commercialized by HUTCHMED and/or its collaboration partners (collectively, “HUTCHMED’s Products”) will achieve any particular revenue or net income levels. In particular, management’s expectations could be affected by, among other things: unexpected regulatory actions or delays or government regulation generally; the uncertainties inherent in research and development, including the inability to meet our key study assumptions regarding enrollment rates, timing and availability of subjects meeting a study’s inclusion and exclusion criteria and funding requirements, changes to clinical protocols, unexpected adverse events or safety, quality or manufacturing issues; the delay or inability of a drug candidate to meet the primary or secondary endpoint of a study; the delay or inability of a drug candidate to obtain regulatory approval in different jurisdictions or the utilization, market acceptance and commercial success of HUTCHMED’s Products after obtaining regulatory approval; discovery, development and/or commercialization of competing products and drug candidates that may be superior to, or more cost effective than, HUTCHMED’s Products and drug candidates; the impact of studies (whether conducted by HUTCHMED or others and whether mandated or voluntary) or recommendations and guidelines from governmental authorities and other third parties on the commercial success of HUTCHMED’s Products and drug candidates in development; the ability of HUTCHMED to manufacture and manage supply chains, including various third party services, for multiple products and drug candidates; the availability and extent of reimbursement of HUTCHMED’s Products from third-party payers, including private payer healthcare and insurance programs and government insurance programs; the costs of developing, producing and selling HUTCHMED’s Products; the ability to obtain additional funding when needed; the ability to obtain and maintain protection of intellectual property for HUTCHMED’s Products and drug candidates; the ability of HUTCHMED to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the successful disposition of its non-core business; global trends toward health care cost containment, including ongoing pricing pressures; uncertainties regarding actual or potential legal proceedings, including, among others, actual or potential product liability litigation, litigation and investigations regarding sales and marketing practices, intellectual property disputes, and government investigations generally; and general economic and industry conditions, including uncertainties regarding the effects of the persistently weak economic and financial environment in many countries, uncertainties regarding future global exchange rates, uncertainties in global interest rates, and geopolitical relations, sanctions and tariffs. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, on AIM and on HKEX. HUTCHMED is providing the information in this announcement as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise. In addition, this announcement contains statistical data and estimates that HUTCHMED obtained from industry publications and reports generated by third-party market research firms. Although HUTCHMED believes that the publications, reports and surveys are reliable, HUTCHMED has not independently verified the data and cannot guarantee the accuracy or completeness of such data. You are cautioned not to give undue weight to this data. Such data involves risks and uncertainties and are subject to change based on various factors, including those discussed above. Inside Information This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (as it forms part of retained EU law as defined in the European Union (Withdrawal) Act 2018). Medical Information This announcement contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. This announcement in its entirety is available at: http://ml.globenewswire.com/Resource/Download/17244442-5d9f-476b-b602-ea9b60a08cf7
TranscriptFY2025 Q42026-03-05FY2025 Q4 earnings call transcript
Earnings source - 99 paragraphs
FY2025 Q4 earnings call transcript
Hello everyone. Welcome to HUTCHMED 2025 full year result and business update. Today we're going to go through our results in a formal presentation by our senior management. It will be followed by Q&A. Before I start, let's turn to page two with our usual safe harbor statement. Basically, the performance and results of our operation contained within this presentation are historical in nature. The past performance is no guarantee of future results. The information in this presentation is subject to changes. HUTCHMED has no liability for any loss arising from the use of this content. My name is David Ng. I'm the head of IR of HUTCHMED. We are very happy that we're going to have our senior management to present the results.
Let me hand off the time to our Acting Chief Executive Officer and Chief Financial Officer, Johnny Cheng. Johnny?
Thank you, David, and thank you everyone for attending HUTCHMED's 2025 results webcast. Joining me today is our Deputy CFO, Lorenso Chiu, who will give us an overview of our financial performance. Our Head of Commercial, George Yuan, who will share with you our commercial performance, and our Head of Discovery, Dr. Guangxiu Dai, who will provide an update on our R&D pipeline progress. Next slide, please. A quick highlight of our 2025 achievements. We are pleased with our ex-China FRUZAQLA sales, which had 26% growth versus last year, resulting in $366 million in in-market sales. More importantly, FRUZAQLA has rolled out to over 38 countries already. As for our China sales, it has rebounded in the second half of the year, achieving 21% in-market sales growth versus our first half interim results.
In terms of our cash position, we have about $1.4 billion, which allows us to accelerate our global ATTC development and provide resources to explore potential in-licensing and M&A opportunities. On the right-hand side, we have now advanced two of our ATTC programs into the clinic, which we believe will have huge market potential. In addition, we are pursuing potential business development opportunities with multinational companies. In terms of the progress of our pipeline, I will leave it to Dr. Dai to share with you later on. I will now turn it over to Lorenso for the financial review and outlook. Lorenso?
Yeah. Thanks, Johnny. Let me give an overview of our key financial highlights for 2025. On total oncology revenue was $286 million. This includes $71 million R&D-related up front and milestone revenues. For oncology products revenue, as Johnny already mentioned, there was a rebound from our China oncology products, which recorded 21% growth in in-market sales in the second half, while FRUZAQLA continues its global expansions. On net income, we recorded a profits of $457 million for 2025, mainly due to the SHPL divestment gain of $160 million. Excluding this one-time gain, our core operations remain profitable. Next, please. Our R&D expenses for 2025 was $148 million. Expenses were lower versus 2024, as many of our late-stage trials are in the completion stage, with multiple NDAs now awaiting approvals.
We began shifting our investments into our early-stage ATTC assets, with two candidates already in the clinic. Our cash position has been further strengthened to about $1.4 billion. That positions us well to accelerate both investments and developments of our ATTC programs. Next. Looking forward to 2026, our oncology revenue guidance is in a range of $330 million-$450 million. This reflects a strong solid growth from 2025, driven by strong growth in our China commercial products, with contributions from new indications as well as the FRUZAQLA continuous global expansions. Let's consider the potential partnership opportunities for our new drug candidates, including ATTC. I'd like to hand over to George to give an overview of the China commercial.
Thanks, Lorenso. First, let's look at FRUZAQLA, our business partner, Takeda's performance. They deliver a very strong 2025 with 26% growth. If you look at the Q2 or the second half, the second half of the growth actually is accelerate mainly due to the market expansion. We launched some of the new market like Portugal, Belgium and South Korea. Also, the strong Japanese performance and some of the Europe performance uptake also contribute a second half strong growth. This reflect a market needs for safe and effective medicine in the later line mCRC treatment. Also, the physicians' experience enhancement and also the reimbursement progress contribute to those growth.
If you look at the U.S., we do see some of the headwind mainly due to the Medicare Part D redesign. Next slides. For China performance under the brand name of ELUNATE. In China, we post -13% growth mainly due to soft performance in the first half as we scale back some of the sales force after our GC second-line setback, and also some of the productivity improvement programs. We successfully turn around the business with more efficient approach to focus on the top-tier cities and hospitals, where in second half we deliver 33% growth and successfully renew our NRDL with no price cut and include our EMC second line. Also, we submit NDA for RCC with those, all contribute to our future growth. Next slide.
If look at the ORPATHYS and the SULANDA, which is 11% of our total 2025 in-market sales, they are relatively soft due to the fierce competition. For SULANDA, we also face multiple PRRT, those nuclear medicine moving to the clinical stage and fighting with us with limited patient pool. Although we have some kind of headwinds, we do see some progress. First is, for ORPATHYS, we have a first-line METex14 adding to the NRDL. We have a such approval to drive future growth. Our SAFFRON/SANOVO will read out what we are expecting in this year. For SULANDA, we maintain our market leader position in net performance in the TKI markets. We have renewed our own NRDL with no price cut. Our phase III PDAC study is on track. Next slides.
We are building on behalf of our in addition to our solid tumor, we are building our hematology portfolio. We get our first medicine, first-in-class treatment for EZH2 mutation and follicular lymphoma approved. This is our first hematology products launched in China. This also give us a beachhead in the hematology. On the TAZVERIK include our China's first commercial insurance drug list, where one of the 19 medicine included this drug list. This give us a kind of future growth opportunity to explore the commercial insurance. On the other side, those TAZVERIK provide us a beachhead in the hematology. To leverage these products, we can engage our hematology opinion leaders, establish our core team with expertise in the hematology to prepare the future hematology launch. Our sovleplenib is prepared to launch early 2027.
Our ITP is already resubmit. The wAIHA indication, we are potentially submit in the first half of 2026. Also, we have additional pipeline in the hematology, the IDH1 and 2 inhibit for the AML and also the BTK in the DLBCL also start our phase III study. In long run, we are aiming to build our very strong hematology portfolio. Now let's turn over to our Dr. Dai.
Thank you, George. I'll provide an update on our R&D pipeline progress. The 2025 proved to be a great year for our pipeline, featured by fast regulatory movement and high impact clinical data. We have achieved major progresses across our core areas, oncology, hematology, and our next generation technology platforms. In oncology, savolitinib has reached critical regulatory and clinical milestones in both China and global markets. SACHI was approved in China in a speed record for second line EGFR mutant MET amplified non-small cell lung cancer. SANOVO and SAFFRON completed phase III re-enrollment and third line gastric cancer filed NDA in China in late December 2025. In hematology, sovleplenib, our Syk inhibitor, has solidified its position with ITP NDA resubmission and robust post positive phase III data readout in wAIHA.
Perhaps most excitingly, our antibody therapy conjugate ATTC platform is now a clinical reality, with our lead assets A251 and A580 moving into global clinical development. A251 has started patient enrollment in China and in the U.S., closely followed by our second ATTC drug candidate, A580, which was first dosed in patients just yesterday. Beyond this, we are seeing broad success with fruquintinib EMC included in NRDL, fruquintinib RCC and fanregratinib IHCC gaining NDA acceptance, and surufatinib moving into phase III for first-line PDAC. Next, I'll dive deep into how these progresses define our growth trajectory. Next slide, please. With savolitinib, we have dual focuses here, maintaining leadership in China and expanding the global footprint.
In non-small cell lung cancer, savolitinib has been approved in China for first- and second-line METex14 alteration as a single agent. For second line, the combination of savolitinib and osimertinib represents a promising chemo-free oral treatment strategy to address mechanisms of resistance due to MET alteration following EGFR TKI treatment in this advancing setting. In this setting, SACHI has been approved in China and SAFFRON is expected to have a readout in May 2026. For first line, SANOVO, a phase III study of savolitinib and osimertinib will read out in the first half of in the second half of 2026 or early 2027. Savolitinib is more than just a lung cancer drug. We also reached an important milestone in gastric cancer with China NDA for third line MET-amplified gastric cancer being accepted and priority review granted.
Next, please. The data from SACHI is compelling. In 2026 The Lancet publication, SACHI study demonstrated a clinically meaningful OS benefit, 22.9 months versus 7.9 months in ITT patients who didn't receive subsequent MET inhibitor treatment. The hazard ratio of 0.32 is a clear indicator of OS benefit. Earlier, we have presented at ASCO that combination of savolitinib and osimertinib shows a clinically meaningful improvement in overall response rate and duration of response versus chemotherapy as second-line treatment. In particular, SACHI demonstrated clinically and statistically meaningful PFS improvement in ITT patients as well as in patients with failed third-generation EGFR TKI treatment. Next slide, please. Turning to sovleplenib, a second inhibitor, our focus is on addressing the large unmet medical needs in immune-mediated hematological disorders. In ITP, we have resubmitted our NDA in China.
NDA has been accepted and granted with a breakthrough therapy designation and priority review. The clinical profile of sovleplenib is highly competitive. In the three-year follow-up study, the median duration of exposure is over 86 weeks. The cumulative durable response reaches over 66 weeks. Over 51% of patients achieved durable response. This is highly consistent with 48.4% durable response rate in a double-blind phase of ESLIM-01 study. Sovleplenib shows a superior durable response rate compared to many existing ITP therapies, including second inhibitor fostamatinib and BTK inhibitor rilzabrutinib, as well as efgartigimod, an FcRn drug approved for ITP in Japan. Sovleplenib's durable response rate is comparable to or better than TPO/TPO-RA drugs. A key differentiation for sovleplenib is its safety, particularly regarding vascular risks.
It's well known that TPO/TPO-RA drugs have been associated with thromboembolic and thrombolic complications in ITP patients. Sovleplenib clearly demonstrates a highly competitive clinical profile in the safety and efficacy. Next slide, please. The ITP market potential is significant and growing. In China alone, there are over 250,000 actively treated ITP patients, representing addressable market of $500 million-$700 million. Next, please. Next is our innovation engine, the ATTC platform. This platform is designed to combine the precise delivery of antibodies with the potency of targeted inhibitors. A251 is the first-in-class ATTC consisting of a potent PI3K/PIKK inhibitor conjugated to an HER2 antibody with a DAR of 4 through a cleavable linker. Next slide.
A251 targets a massive global market across several HER2-expressing solid tumors, including breast cancer, gastric, gynecologic cancer, and many other HER2-expressing cancer types. Next, please. The scientific and strategic importance of this platform targeting the PAM pathway cannot be overstated. The PAM pathway is the most frequently altered pathway in solid tumors, appearing in 38%-50% of all tumor cases, much higher than the other major drivers like RAS, HER2, EGFR, and ALK. For instance, PAM alterations are often seen in breast cancer, gastric, ovarian, and prostate cancers. This gives A251 and other assets from this platform a massive total addressable market. Next slide. While small molecule inhibitors targeting PAM pathway and PIKK pathway have historically faced issues with high toxicities and poor DMPK properties. It is always challenging to balance clinical efficacy and safety.
The ATTC platform is designed to reduce these on-target off-tumor toxicities by delivering the payload directly to the tumors. The A251 payload is a potent inhibitor targeting multiple nodes in PAM pathway and PI3K pathway, with high affinities in PI3Kα, other PI3K isoforms, and in mTOR, ATR, and ATM. Its biochemical profile significantly differentiates from the profiles of the others targeting PAM and PI3K. We believe this is an advantage of the ATTC approach. The payload demonstrates high kinase specificity in a broad kinase panel, hitting targets in the two families only. Next slide. A251 demonstrates strong HER2-dependent inhibitory activities, meeting IC50s in the range of 0.2 nanomolar in HER2-positive cells, regardless of PAM status, in a single-digit nanomolar in HER2 low compared to 36 nanomolar in HER2 null cells.
The HER2 expression level really determines how much of the payload is delivered to the tumor cells, and how potent A251 can be. Crucially, A251 exhibits a bystander effect that allows it to overcome HER2 heterogeneity by killing neighboring HER2 null cells. The preclinical data has been published at the 2025 EORTC conference. Next slide, please. A251 has started the global phase I study in the U.S. and in China. The dose escalation and the building dose expansion and optimization is essentially one study in China and U.S. following the same protocol. We believe this is the fastest way to define a global dose. The trial targets HER2 expressing solid tumors with PAM status being tested virtual respectively. This will inform the biomarker strategy for future development.
The strategy includes utilizing A251 as a monotherapy for later-line treatment and exploring combination therapies in frontline setting. Next slide. We are accelerating discovery and development of ATTC and ADCs, this is the next-generation innovation timeline. Our second ATTC asset, A580, has started the phase I, opening sites and recruiting patients in China and in the U.S. The third ATTC asset, A830, is anticipated to enter global phase I this year. We are committed to maintain the momentum from the innovative platform in the coming years. Next slide. Looking ahead next 15 months, the upcoming milestones include for savolitinib, we expect readouts for both SAFFRON and SANOVO. We anticipate the label expansion with China NDA approval for the third line gastric cancer indication.
For savolitinib, our phase III trial in wAIHA successfully met its primary endpoint, clearing the path for the next regulatory filing, which will happen in the coming months. Our next major milestone will be the China NDA approval for ITP. For the innovation platform, three ATTCs will all be in the clinical development in 2026. Beyond these highlights today, we expect China NDA approvals for fruquintinib RCC and fanregratinib in IHCC, as well as surufatinib PDAC enrollment completion within the next 15 months. We look forward to another great year. With that, I'll turn back to our acting CEO, John.
Thank you, Dr. Dai. In summary, we are very excited about our outlook for 2026 and beyond. We have multiple potential NDA filings upcoming, including from SAFFRON and SANOVO readouts later this year. In addition, our new hematology products are expected to drive future sales growth in China. On the innovation side, our strategic efforts will be focused on accelerating global development of our ATTC programs. At the same time, exploring business development opportunities to further validate and add value to this platform. Finally, our oncology revenue guidance of $330 million-$450 million factors in our FRUZAQLA ex-China commercial growth and the positive impact of adding new indications for ELUNATE. With that, I will turn it over to David to start our Q&A session.
Thank you, Johnny. Thank you, everyone for the presentation. We will now do the Q&A session. First a little bit of the instructions. If you look at the bottom of your screen, you can see the Raise Hand button. If you have a question, please press the Raise Hand button, and I will call your name and unmute your line. Another way that you can ask question is in the chat box. Also, at the bottom of your screen, you can press that chat button, and then you can type in your questions, and then I can read out the questions. The first question come from CLSA, Matthew Yan. Matthew, your line is now unmuted. You can ask your question.
Hello. Thanks for taking my questions and the comprehensive elaboration of the results. Congratulate on the result then. Got a few questions. First is regarding the oncology, you know, guidance in 2026. Because in 2025 you see the multiple, you know, for example, sales team restructuring or kind of stuff. The growth is actually a decrease. The 2026 guidance, it seems to be imply something 15%-16% year-over-year oncology growth. Can you elaborate a bit more, little bit more about how I should be modeling the kind of the key drugs sales from this? Yes. This is my first question. I will aggregate, ask my question in one batch. Second thing is about the SAFFRON's kind of readout.
Do you have any color why the top line readout has been delayed from first half to second half? The third question is, the last question is about can you elaborate more on the indication of the ATTC platform, the first two candidates into the clinics, for example, the A251 uses. Am I understanding right that it's more like on the post in HER2, the refractory breast cancer setting or what kind of a setting we are looking at in the future? Thanks.
Thank you, Matthew. For the first question, I would refer to Lorenso, and the second and third questions to, Guang, Dr. Dai. Lorenso?
Yep. about the guidance as. Hi, Matthew. Thanks for your questions. about the guidance, as you pointed out, for 2025, there was a decline in the product sales. As you can see, in the second half, we saw a seed strong momentum of recovery. We expect that this will continue in the 2026. Together we'd like to highlight that we're expecting more growth coming from the new indications. As you can see, we have the NDA RCC, which is currently under reviewed. We believe that with that approval that will bring in more revenue under growth. Also, about the FRUZAQLA, there's a strong growth in 2026 expected due to the continued expansions, particularly.
Also, we can see that there are more and more countries now in the market. With that full year penetrations in 2026, they will continue the growth. Yes. Johnny, do you have anything to add?
Okay. second and third question, Guangxiu, Dr. Dai?
Yes. The SAFFRON readout is expected to happen in mid 2026. The third question, A251 now is enrolling HER2 expressing solid tumor patients, now restricted to post in HER2 patients.
Great. Thank you.
All right. David?
Okay. Thank you, Matthew. The next question comes from Matthew Guggenbiller. Matthew, your line is now unmuted. You can ask your question now. Go ahead, Matthew.
Hey, can you hear me okay?
Yes.
Great. This is Matthew on for Alec Stranahan from Bank of America. I guess two questions from us. On the SAFFRON readout, you said, expected May 2026. Could you maybe clarify, you know, expected location of that medical meeting versus company event? For ATTC readouts, can you just maybe clarify, you know, expected patient number, sort of follow-up we can expect from those? Thanks.
Dr. Dai?
Okay. The SAFFRON readout will be in, like I said, in the mid-2026. We'll share the data as soon as, you know, AZ informs us of the results. What's your second question? Sorry. Can you repeat your question?
Yeah. In terms of initial clinical data for the ATTC assets, sort of size and scope of those in terms of patient number follow-up.
The trial is still at early stage. We don't have a definitive timeline for the data readouts.
Gotcha. Maybe one on commercial dynamics as well. You know, I think first half had some headwinds from off-label sales, increased generic competition, and sort of sales force turnover. I guess, can you speak to, you know, how those trends are looking in the second half and whether you expect those to stabilize throughout 2026? Thanks.
Okay. Matthew, we'll invite our Head of Commercial, George, to answer this question.
Yeah. We, because we cannot, the, for the GC, last year, we faced some GC setback. The indication is not get approved. That's why if you look at our sales force, the original setting is we prepare for the GC, so the field force is a little bit over capacity when we lost the GC indication. That's why we rationalize the team and also when we try to focus more on the top hospitals. That's why we have some kind of reorg in the team, which lead to some kind of performance issue in the Q1 and the first half. Everything is moving into the right direction. The turnover rate is significantly reduced. Also, the vacancy is already filled.
That's why we have a very strong team now, and those kind of momentum will carry over to 2026.
Thank you, George.
Okay. No follow-up question, David.
Yeah. Thank you. Next question from Cavendish, Adam. Adam, your line is now unmuted. You can ask your question.
Thanks very much. Thanks, thanks for the presentation. A couple of questions. Just in today's announcement, I noticed that you mentioned that AstraZeneca continues its effort, its efforts to increase MET testing as a standard of care in late stage non-small cell lung cancer. Could you comment on how the pace of MET testing adoption might influence the potential uptake of savolitinib in the SACHI setting in China, and then globally if SAFFRON is successful?
Yeah. Dr. Dai, and yep.
Oh, we do not have additional information on this question.
Okay. No, no problem. Thanks very much. Just on a second question. On the ATTC platform, could you elaborate on your partnering strategy, you're pursuing with the multinational pharmaceutical companies? More specifically, are you considering out-licensing certain assets earlier in development to accelerate validation of the platform while potentially regaining greater control over other assets to maximize longer term value?
Well, I think I will answer these questions. In terms of our strategy for the partnering with the ATTC program. First of all, I think, as you can see, we have a strong pipeline already building up for this ATTC platform. We now have positive responses from potential partners, and many of which are multinational companies. We have ongoing discussion with all those potential partners. With our large portfolio that we anticipate that we will build on, I think, we want to advance and accelerate this development. Hence, we have considered to potentially license out some of these programs.
Also in addition, I think, we also have this AI capability, which we can further develop some more candidates into our platform as a result. I think this is why we also consider potential partnering opportunities. Furthermore, I think, as this platform is really one of our next wave, we would also like to validate this through this partnering strategy.
That's great. Thank you. I guess just if I could try my hand at a third, final question. It's just sort of maybe a broader one. As we think about the HUTCHMED story going forward, how should investors balance the contribution of the existing commercial portfolio against the emerging opportunity from the ATTC platform? In particular, do you see the next phase of value creation increasingly driven by the pipeline and the platform assets rather than the marketed product?
Well, we see as we have our second wave of as we mentioned hematology asset that will be going into the commercial side that would adding to our existing already commercialized portfolio. That would increasing our balance of our investment in R&D. We will continue to ramp up our R&D expenditure. Last year in 2025, in terms of our investment in R&D was probably the lowest in recent years, mainly due to a lot of programs were waiting for approval, pending for approval. We are also at the early stage of development of this ATTC program. Going forward, we do take this accelerate our global development strategy for ATTC.
At the same time, with the expanded commercial assets, we will be able to generate more income so we can balance out our ATTC investment.
That's excellent. Thank you very much, and thanks for taking my questions.
Thank you, Adam. The next question is coming from UBS, Chen Chen. Chen Bo, your line is now unmuted. You can ask your question.
Thank you for taking my question. Well, my first question is on surufatinib. We see that it has started this patient enrollment. I'm interested in is like partner strategy. Are you considering like a BD, like after data result? You are now in talks with any potential partners right now? The phase III will enroll like a few hundred people, so it would be very expensive. Thank you.
Okay. I will answer from a strategic side. Then I will invite Dr. Dai to comment further. We have no... at the moment, no intentions to partner this program out. Dr. Dai, in terms of the status of our development, perhaps you can comment a little bit.
Sure, Johnny. The phase III first patient in has was achieved in December 2025, we hope to finish the phase III enrollment in the next 15 months. We hope that surufatinib can provide another therapeutic option for the first time PDAC patients. Agree with Johnny that currently we don't have a licensing plan.
I see. That's very clear. Well, my second question is on your, like, R&D guidance in this year. We noticed that you have started, like, a few phase III trials such as, like, surufatinib, as we discussed just now. Also, like BTK, DLBCL, and also a few, like, early-stage trials such as ATTC candidates. I'm just wondering, like, what's your guidance for your R&D expense this year?
Okay, just to clarify, we do not give out any public guidance on R&D expenditure. But as we mentioned that 2025 was the lowest level. We do intend to ramp up, as you also mentioned a number of programs that we are actually advancing, as well as our strategy on accelerating our ATTC program. Going forward, in the next few years, we do want to ramp up to a very reasonable kind of a higher level of investment on R&D. In the range of, you know, in the range of $250 million-$300 million, I think that would be the ideal level of R&D investment. Of course, we will be stick to our commitment to the investors that we will be profitable in a sustainable situation.
Therefore, we will be investing as we will be able to generate sufficient commercial income to cover our R&D investment.
Okay, great. maybe, the last question from me. I saw that you have very strong cash position by the end of 2025, and you also mentioned that you are planning to do some, like, in-license and also some M&A. Can you please elaborate a bit more on that side? Thank you.
Yes. We have $1.4 billion of cash on hand. Our priority is of course, as we mentioned, accelerating our global development for ATTC program. We are open because with this cash resources, we are open if the opportunity arise for in-licensing late-stage commercial assets or potentially some assets that is complementary to our portfolio. I think, I think M&A and this in-license opportunity, we are open-minded because we are in a good financial position, but we have no fixed target at this stage.
Okay. That's very clear. Thank you so much.
Thank you, Chen Bo. The next question, come from, Panmure, Julie Simmonds. Julie, your line is now unmuted. You can ask your question.
Thank you very much. I was just wondering on the move into hematology products, whether this changes what you're investing in sales and marketing and what changes to the sales infrastructure it requires. Thank you.
Thank you, Julie. George.
Yeah.
Would you like to comment on this? Thank you.
Because hematology is a very specialized team, that's why we already start up a new business unit with dedicated sales, marketing, and medical capability to address this kind of market opportunity. With the future pipeline adding to the business, we will expand the team.
Lovely. Thank you. Secondly, just on the impact in the U.S. of the Medicare Part D changes, just wondering how much impact you expect that to have on sales in 2026, whether you can make any comment?
Sorry, I didn't hear your question. Could you repeat again?
Yes. Just questioning about the changes to Medicare Part D that went on in the States, that were obviously impacting your sales, there. If you've got any thoughts on what impact that might have into 2026.
We have received no new changes so far. The impact factors into 2025 has been reflected. Despite that impact for U.S., I mean, we still achieve a 26% growth for our FRUZAQLA through our partners. We do anticipate that in 2026, we will be expanding, rolling out of all the ex-U.S. countries. So far, already 38 countries have been commercialized in terms of this FRUZAQLA. We continue to see that the NRDL in those countries will be expanded.
Okay.
The total impact for ex-China sales, we see that, U.S. will continue to grow, but also outside of U.S., that is the key driver also.
Thank you.
Thank you, Julie. Next question coming from Daiwa, Wilfred Yuen. Wilfred, your line is now unmuted. You can ask your question.
Thanks. Thanks for taking my question. I want to follow up on the revenue guidance that range from $330 million-$450 million, which is a wider range, first to last year anyway. Maybe can you give us more color as to the breakdown between the oncology product sales and the R&D milestones payment? Are you expecting some additional milestone, you know, maybe to hit the high end of the guidance $450? Thanks.
Lorenso, would you like to tackle this question? I will add to it.
Yep. Further to what I explained earlier, I think you can look in this way, because we do not give any guidance of particular items within this revenue guidance. For your information, I think it would be worth to note that in 2025, our revenue has included some of the upfront and milestones, which, if you exclude those, the base would be lower. For the 2026, the guidance reflect a kind of a solid growth from 2025. In addition, I think some of the factors that I've mentioned, the growth from our China trial products with the new label expansions and also the new indications, will drive further growth. I hope that could address the questions.
Johnny, do you want to add some more comments on this?
Wilfred, I think, basically, you should take the guidance as the middle of this range, right? The low end potentially if some of the, you know, at this I think the low end of the guidance is where we are very confident, and we are also very confident that to achieve higher of this guidance. $330 has factored in, as Lorenso said, many of the organic growth. In addition, we also factor in for a base, kind of baseline growth for our ex China sales, which of course is run by our partner.
Conservative speaking, we are very conservative to give this low-end guidance. You can expect the mid-range of that is almost like a 36% growth between $330 million to $450 million is about $390 million. That is more like 36% growth versus this year's 2025's performance. I think this is guidance that basically can reflect the business growth as well as the potential. If we have licensing, of course we won't take all the upfront income. We will potentially apportion part of the upfront income and factoring into the upside.
Got it. Thanks for the color. Thanks.
Thank you, Wilfred. next question coming from Goldman Sachs, Paul Choi. Paul, your line is now unmuted. You can ask your question.
Hello. Thank you for taking our question. My question is on savolitinib assuming, you know, clinical success coming up here with SAFFRON. Can you maybe comment on how you think a TAGRISSO savolitinib combination would be sequenced in the treatment paradigm given the recent launch of J&J's RYBREVANT bispecific? Just, you know, how you think about guidelines involving directing oral options versus bispecific options. Thank you very much for taking our question.
Yeah, thank you. George, you have any color to share on this?
Yeah. I think this first thing is this provides an oral, two oral products for those EGF resistant MET amplification patients. This is, we provide very efficacy and as well as convenience. We do know the J&J bispecific monoclonal antibody do provides another options. All depends on doctor's perception regarding how the treatment paradigm shifts. Is still precision medicine winning the game or not? The testing, the second, third testing win the game or not? It depends on how AstraZeneca shaping the treatment.
Okay. Thank you.
Thank you, Paul. I see a couple of questions on in the chat box. Some of that actually has been kind of answered already. There's a question, this is Johnny. The question is, what is the thoughts about the need to decide appointment of a permanent CEO, or are we happy with the current situation?
Okay. I think we have the company have made an announcement in August. I think no status change as yet regarding the announcement. Dr. Su is focusing on his health right now and yep. We have this interim arrangement and as you can see, we have a lot of talents within our management team. Today, we have Dr. Dai and also we have Lorenso Chiu joining this webcast. The company have been running for 20 odd years, and we have a very loyal and also capable talents within our talent pool. Everything has been running very, very smoothly and also progressing in terms of our pipeline as well as our commercial strategy. Everything it is now working as per plan.
Thank you, Johnny. I don't see any outstanding questions right now. Just as a reminder, if anyone has any question, please press the raise hand button or type your question in the Q&A box. There's another question talking about SAFFRON read-out delay from first half to second half. As you know, Dr. Dai has mentioned the most likely scenario will be around mid-2026. If no further questions, Johnny, would you like to do a concluding remark?
I think thank you again, everyone for spending the time to attend this webcast. If you have further questions, please, by all means, to feed through our IR colleagues. Thank you.
Thank you, everyone. This concludes our results, presentation. Thank you very much.
Investor releaseQuarter not tagged2026-02-06HUTCHMED to Announce 2025 Final Results
GlobeNewswire
HUTCHMED to Announce 2025 Final Results
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Feb. 06, 2026 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; SEHK:13) will be announcing its final results for the year ended December 31, 2025 on Thursday, March 5, 2026 at 6:00 am Eastern Standard Time (EST) / 11:00 am Greenwich Mean Time (GMT) / 7:00 pm Hong Kong Time (HKT). HUTCHMED management will host two webcast presentations for analysts and investors to discuss the final results, followed by Q&A sessions. The English webcast will be held on Thursday, March 5, 2026, at 8:00 am EST (1:00 pm GMT / 9:00 pm HKT). The Chinese (Putonghua) webcast will be held at 8:30 am HKT / 12:30 am GMT on Friday, March 6, 2026 (7:30 pm EST on Thursday, March 5, 2026). Both webcasts will be available live via the website of the Company at www.hutch-med.com/event/. The presentation will be available to download shortly before the webcast begins. A replay will also be available on the website shortly after the event. About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: www.hutch-med.com or follow us on LinkedIn. CONTACTS
Investor releaseQuarter not tagged2026-01-14HUTCHMED Highlights Publication of Phase III SACHI Results in The Lancet
GlobeNewswire
HUTCHMED Highlights Publication of Phase III SACHI Results in The Lancet
— First randomized Phase III trial confirming the efficacy of MET inhibition in patients with advanced NSCLC and acquired MET amplification after progression on prior EGFR-TKI treatment — — Savolitinib and osimertinib combination approved in China in June 2025 — HONG KONG, SHANGHAI and FLORHAM PARK, N.J., Jan. 14, 2026 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today highlights that results from the SACHI Phase III trial were published in The Lancet. SACHI is a Phase III study of the savolitinib (ORPATHYS®) and osimertinib (TAGRISSO®) combination for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor (“EGFR”) mutation-positive non-small cell lung cancer (“NSCLC”) with MET amplification after disease progression on first-line EGFR tyrosine kinase inhibitor (“TKI”) therapy. Savolitinib is an oral, potent and highly selective MET TKI being jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca. Osimertinib is a third-generation, irreversible EGFR TKI. Based on interim data from SACHI, the savolitinib and osimertinib combination was granted regulatory approval in China in June 2025. “The SACHI trial, now published in The Lancet, provides compelling evidence that savolitinib combined with osimertinib can transform outcomes for patients with EGFR-mutated NSCLC with MET amplification. These findings highlight the combination’s ability to address MET amplification, a critical resistance mechanism, offering clinically meaningful improvements for this challenging patient population,” said Professor Shun Lu, Chief of the Shanghai Lung Cancer Center at Shanghai Chest Hospital, School of Medicine, Shanghai Jiaotong University, and co-leading Principal Investigator of the SACHI trial. “We are particularly encouraged by the consistent benefits observed in patients previously treated with third-generation EGFR-TKIs, where savolitinib plus osimertinib offers a continued all-oral regimen, providing a convenient and well-tolerated solution for this underserved population.” Professor Jie Wang of Cancer Hospital, Chinese Academy of Medical Sciences also served as co-leading Principal Investigator of the SACHI trial. About the SACHI Phase III Trial In January 2025, the Independent Data Monitoring Committee (IDMC) of SACHI considered that the study had met the pre-defined…Read full documentShow less
— First randomized Phase III trial confirming the efficacy of MET inhibition in patients with advanced NSCLC and acquired MET amplification after progression on prior EGFR-TKI treatment — — Savolitinib and osimertinib combination approved in China in June 2025 — HONG KONG, SHANGHAI and FLORHAM PARK, N.J., Jan. 14, 2026 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today highlights that results from the SACHI Phase III trial were published in The Lancet. SACHI is a Phase III study of the savolitinib (ORPATHYS®) and osimertinib (TAGRISSO®) combination for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor (“EGFR”) mutation-positive non-small cell lung cancer (“NSCLC”) with MET amplification after disease progression on first-line EGFR tyrosine kinase inhibitor (“TKI”) therapy. Savolitinib is an oral, potent and highly selective MET TKI being jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca. Osimertinib is a third-generation, irreversible EGFR TKI. Based on interim data from SACHI, the savolitinib and osimertinib combination was granted regulatory approval in China in June 2025. “The SACHI trial, now published in The Lancet, provides compelling evidence that savolitinib combined with osimertinib can transform outcomes for patients with EGFR-mutated NSCLC with MET amplification. These findings highlight the combination’s ability to address MET amplification, a critical resistance mechanism, offering clinically meaningful improvements for this challenging patient population,” said Professor Shun Lu, Chief of the Shanghai Lung Cancer Center at Shanghai Chest Hospital, School of Medicine, Shanghai Jiaotong University, and co-leading Principal Investigator of the SACHI trial. “We are particularly encouraged by the consistent benefits observed in patients previously treated with third-generation EGFR-TKIs, where savolitinib plus osimertinib offers a continued all-oral regimen, providing a convenient and well-tolerated solution for this underserved population.” Professor Jie Wang of Cancer Hospital, Chinese Academy of Medical Sciences also served as co-leading Principal Investigator of the SACHI trial. About the SACHI Phase III Trial In January 2025, the Independent Data Monitoring Committee (IDMC) of SACHI considered that the study had met the pre-defined primary endpoint of progression-free survival (“PFS”) in a planned interim analysis and, as a result, enrollment into the study has concluded. As of the interim analysis data cut-off of August 30, 2024, a total of 211 patients were randomized to receive the savolitinib and osimertinib combination (n=106) or chemotherapy (n=105). In the intention-to-treat (“ITT”) population, the median PFS assessed by investigator was 8.2 months (95% confidence interval [“CI”] 6.9–11.2) with savolitinib plus osimertinib, compared to 4.5 months (95% CI 3.0–5.4) with chemotherapy (hazard ratio [“HR”] 0.34; 95% CI 0.23–0.49; p<0.0001). The independent review committee (“IRC”) assessed median PFS was 7.2 vs 4.2 months, respectively (HR 0.40; 95% CI 0.28–0.59; p<0.0001). The investigator-assessed objective response rate (“ORR”) was 58% in the savolitinib plus osimertinib arm compared to 34% for patients in the chemotherapy arm. The disease control rate (DCR) was 89% vs 67%, and the median duration of response (DoR) was 8.4 vs 3.2 months, respectively. The median time to response (TTR) was similar between two arms (1.4 vs 1.5 months). Overall survival (“OS”) data were still evolving and not mature at the time of the interim analysis, with only 37% and 43% OS maturity. At median OS follow-up duration of 17.7 months in the ITT population, savolitinib plus osimertinib arm reported median OS of 22.9 months vs 17.7 months in the chemotherapy arm (HR 0.84). 55 (52%) patients in the chemotherapy arm received subsequent MET inhibitor therapy after disease progression, with 45 (43%) crossing over to savolitinib-osimertinib and ten (10%) subsequently received MET inhibitor. In sensitivity analyses of OS to adjust for this crossover, the OS benefits of the savolitinib plus osimertinib arm were more significant, with HRs ranging from 0.24 to 0.62. In the third-generation EGFR TKI–naïve subgroup population (i.e. patients previously treated with a first- or second-generation EGFR TKI), investigator-assessed median PFS was 9.8 vs 5.4 months (HR 0.34; 95% CI 0.21–0.56; p<0.0001). Efficacy outcomes in the third-generation EGFR-TKI–treated subgroup were comparable with those in the ITT population. In this subgroup, the investigator-assessed median PFS was 6.9 vs 3.0 months (HR 0.32; 95% CI 0.18–0.57; p<0.0001), and IRC-assessed median PFS was 6.9 vs 3.0 months (HR 0.32; 95% CI 0.18–0.58; p<0.0001). The safety profile of the savolitinib and osimertinib combination was tolerable and no new safety signals were observed. Treatment-emergent adverse events (“TEAEs”) of Grade 3 or above occurred in 57% of patients in the savolitinib plus osimertinib arm compared to 57% (55 of 96) for patients in the chemotherapy arm. Common Grade ≥3 TEAEs (≥10% in either arm) included decreased neutrophil count (14% vs 26%), decreased white blood cell count (7% vs 13%), and anemia (4% vs 23%). About NSCLC and MET aberrations Lung cancer is the leading cause of cancer death, accounting for about one-fifth of all cancer deaths.1 Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC.2 The majority of NSCLC patients (approximately 75%) are diagnosed with advanced disease, and approximately 10-15% of NSCLC patients in the US and Europe and up to 40-50% of patients in Asia have EGFR-mutated (“EGFRm”) NSCLC.3,4,5,6,7 MET is a tyrosine kinase receptor that has an essential role in normal cell development. MET overexpression and/or amplification can lead to tumor growth and the metastatic progression of cancer cells, and is one of the mechanisms of de novo or acquired resistance to EGFR TKI for metastatic EGFRm NSCLC.8,9 About ORPATHYS® ORPATHYS® (savolitinib) is an oral, potent and highly selective MET TKI that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression. ORPATHYS® is approved in China and is marketed by AstraZeneca for the treatment of adult patients with locally advanced or metastatic NSCLC with MET exon 14 skipping alteration, representing the first selective MET inhibitor approved in China. ORPATHYS® is also approved in China for the treatment of patients with locally advanced or metastatic EGFRm-positive non-squamous NSCLC with MET amplification after disease progression on EGFR TKI therapy, in combination with TAGRISSO®. It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers as a single treatment and in combination with other medicines. About TAGRISSO® TAGRISSO® (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system (CNS) metastases. TAGRISSO® (40mg and 80mg once-daily oral tablets) has been used to treat more than one million patients across its indications worldwide and AstraZeneca continues to explore TAGRISSO® as a treatment for patients across multiple stages of EGFRm NSCLC. There is an extensive body of evidence supporting the use of TAGRISSO® in EGFRm NSCLC, and it is the only targeted therapy shown to improve patient outcomes across all stages of the disease. In late-stage disease, TAGRISSO® demonstrated improved outcomes as monotherapy in the FLAURA Phase III trial and in combination with chemotherapy in the FLAURA2 Phase III trial. TAGRISSO® is also being investigated in this setting in combination with ORPATHYS® (savolitinib) in the SAFFRON Phase III trial and in combination with DATROWAY® (datopotamab deruxtecan or Dato-DXd) in the TROPION-Lung14 and TROPION-Lung15 Phase III trials. TAGRISSO® also showed improved outcomes in early-stage disease in the NeoADAURA and ADAURA Phase III trials and in locally advanced stages in the LAURA Phase III trial. As part of AstraZeneca’s ongoing commitment to treating patients as early as possible in lung cancer, TAGRISSO® is also being investigated in the early-stage adjuvant resectable setting in the ADAURA2 Phase III trial. About ORPATHYS® and TAGRISSO® Combination Development in EGFR-mutated NSCLC This combination represents a promising chemotherapy-free oral treatment strategy to address mechanisms of resistance in this setting. Among patients who experience disease progression following treatment with a third-generation EGFR TKI, approximately 15-50% present with MET aberration, depending on the sample type, detection method and assay cut-off used. TAGRISSO® is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system metastases. Treatment with ORPATHYS® in combination with TAGRISSO® has been studied extensively in these patients in the TATTON study (NCT02143466) and the SAVANNAH single-arm Phase II study (NCT03778229). Strong data from SAVANNAH presented at the 2025 European Lung Cancer Congress (ELCC) demonstrated high, clinically meaningful and durable ORR, with consistent safety results. The encouraging results led to the initiation of several randomized Phase III trials in this setting including the SACHI trial in China (NCT05015608) and the global SAFFRON trial (NCT05261399), as well as the SANOVO trial in China (NCT05009836). SACHI: This Phase III trial in China evaluated the combination of ORPATHYS® and TAGRISSO® compared to platinum-based doublet chemotherapy for the treatment of patients with EGFRm, MET-amplified locally advanced or metastatic NSCLC following progression on treatment with an EGFR TKI. Results were presented at the 2025 ASCO Annual Meeting. The treatment combination received approval in China in June 2025. SAFFRON: This ongoing global Phase III trial is to evaluate the combination of ORPATHYS® and TAGRISSO® compared to platinum-based doublet chemotherapy in patients with EGFRm, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC following progression on treatment with TAGRISSO®. This received Fast Track Designation from the US FDA and enrollment was completed in October 2025. We look forward to completing this trial to support potential US and other global registration filings. SANOVO: This ongoing Phase III trial in China is to evaluate the combination of ORPATHYS® and TAGRISSO® compared to TAGRISSO® monotherapy in previously untreated patients with locally advanced or metastatic NSCLC with EGFRm and MET overexpression. Enrollment was completed in August 2025. About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: www.hutch-med.com or follow us on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including its expectations regarding the therapeutic potential of ORPATHYS®, the further clinical development for ORPATHYS®, its expectations as to whether any studies on ORPATHYS® would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study’s inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of ORPATHYS®, including as a combination therapy, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in other jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential market of ORPATHYS® for a targeted indication; and HUTCHMED and/or its partner’s ability to fund, implement and complete its further clinical development and commercialization plans for ORPATHYS®, and the timing of these events. In addition, as certain studies rely on the use of other drug products such as TAGRISSO® as combination therapeutics with ORPATHYS®, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of these therapeutics. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. CONTACTS
Investor releaseQuarter not tagged2026-01-07HUTCHMED Announces Positive Topline Results of Phase III Part of ESLIM-02 Trial of Sovleplenib for Warm Antibody Autoimmune Hemolytic Anemia in China
GlobeNewswire
HUTCHMED Announces Positive Topline Results of Phase III Part of ESLIM-02 Trial of Sovleplenib for Warm Antibody Autoimmune Hemolytic Anemia in China
— Delivers rapid, durable responses in wAIHA, the more common form of this potentially life-threatening disease — HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Jan. 07, 2026 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the Phase III registration part of the ESLIM-02 clinical trial of sovleplenib, a novel spleen tyrosine kinase (“Syk”) inhibitor, in adult patients with warm antibody autoimmune hemolytic anemia (“wAIHA”) in China has met its primary endpoint of durable hemoglobin (Hb) response rate within weeks 5 to 24 of treatment. Autoimmune hemolytic anemia (“AIHA”) is an autoimmune disorder characterized by the destruction of red blood cells (“RBCs”) due to the production of antibodies against RBC. The incidence of AIHA is estimated to be 0.8-3.0/100,000 adults per year with an estimated prevalence of 17 per 100,000 adults and a death rate of 8-11%.1,2 wAIHA is the most common form of AIHA,3 accounting for about 75-80% of all adult AIHA cases.4 ESLIM-02 is a randomized, double blind, placebo-controlled China Phase II/III study in adult patients with primary or secondary wAIHA who had relapsed or were refractory to at least one prior line of standard treatment. Results from the Phase II part of the study published in The Lancet Haematology in January 2025 demonstrated encouraging hemoglobin benefit compared with placebo, with overall response rate of 43.8% vs 0% in the first 8 weeks, and overall response rate of 66.7% during the 24 weeks of sovleplenib treatment (including patients that crossed over from placebo) with a favorable safety profile.5 Additional details may be found at clinicaltrials.gov, using identifier NCT05535933. Professor Fengkui Zhang of the Chinese Academy of Medical Sciences Blood Diseases Hospital, and one of the leading principal investigators of the ESLIM-02 study, said: “Warm antibody autoimmune hemolytic anemia is a highly heterogeneous and often chronically relapsing disease. Patients often experience symptoms like fatigue significantly impacting patients’ quality of life. In severe cases, the disease can become life-threatening if not managed effectively. The positive topline results from ESLIM-02 highlight sovleplenib's potential to deliver rapid and durable hemoglobin responses in wAIHA patients who have limited options after failing standard therapies. This could rep…Read full documentShow less
— Delivers rapid, durable responses in wAIHA, the more common form of this potentially life-threatening disease — HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Jan. 07, 2026 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the Phase III registration part of the ESLIM-02 clinical trial of sovleplenib, a novel spleen tyrosine kinase (“Syk”) inhibitor, in adult patients with warm antibody autoimmune hemolytic anemia (“wAIHA”) in China has met its primary endpoint of durable hemoglobin (Hb) response rate within weeks 5 to 24 of treatment. Autoimmune hemolytic anemia (“AIHA”) is an autoimmune disorder characterized by the destruction of red blood cells (“RBCs”) due to the production of antibodies against RBC. The incidence of AIHA is estimated to be 0.8-3.0/100,000 adults per year with an estimated prevalence of 17 per 100,000 adults and a death rate of 8-11%.1,2 wAIHA is the most common form of AIHA,3 accounting for about 75-80% of all adult AIHA cases.4 ESLIM-02 is a randomized, double blind, placebo-controlled China Phase II/III study in adult patients with primary or secondary wAIHA who had relapsed or were refractory to at least one prior line of standard treatment. Results from the Phase II part of the study published in The Lancet Haematology in January 2025 demonstrated encouraging hemoglobin benefit compared with placebo, with overall response rate of 43.8% vs 0% in the first 8 weeks, and overall response rate of 66.7% during the 24 weeks of sovleplenib treatment (including patients that crossed over from placebo) with a favorable safety profile.5 Additional details may be found at clinicaltrials.gov, using identifier NCT05535933. Professor Fengkui Zhang of the Chinese Academy of Medical Sciences Blood Diseases Hospital, and one of the leading principal investigators of the ESLIM-02 study, said: “Warm antibody autoimmune hemolytic anemia is a highly heterogeneous and often chronically relapsing disease. Patients often experience symptoms like fatigue significantly impacting patients’ quality of life. In severe cases, the disease can become life-threatening if not managed effectively. The positive topline results from ESLIM-02 highlight sovleplenib's potential to deliver rapid and durable hemoglobin responses in wAIHA patients who have limited options after failing standard therapies. This could represent a meaningful advancement for managing this challenging condition.” Professor Bin Han of Peking Union Medical College Hospital and Professor Lianshan Zhang of The Second Hospital of Lanzhou University were also co-leading Principal Investigators of the study. Full results of the ESLIM-02 study will be submitted for presentation at an upcoming scientific conference. HUTCHMED plans to submit the New Drug Application (“NDA”) for sovleplenib for wAIHA to the China National Medical Products Administration (NMPA) in the first half of 2026. About Sovleplenib and wAIHA Sovleplenib is a novel, investigational, selective small molecule inhibitor for oral administration targeting the spleen tyrosine kinase, also known as Syk. Syk is a major component in B-cell receptor and Fc receptor signaling and is an established target for the treatment of multiple subtypes of B-cell lymphomas and autoimmune disorders. The accelerated clearance of antibody-coated RBCs by immunoglobulin Fc-gamma receptor (FcγR) bearing macrophages is thought to be the pathogenic mechanism in wAIHA.6 Activated Syk mediates downstream signaling of the activated Fc receptors in phagocytic cells, resulting in phagocytosis of RBCs.7 In addition, activation of Syk through the B-cell receptor mediates activation and differentiation of B-lymphocytes into antibody secreting plasma cells.8 Inhibition of Syk may have potential effects in the treatment of wAIHA through inhibition of phagocytosis and reduction of antibody production. In addition to wAIHA, sovleplenib is also being studied in immune thrombocytopenia (“ITP”). Positive results from ESLIM-01 (NCT05029635), a Phase III trial in China of sovleplenib in patients with primary ITP, have been published in The Lancet Haematology. An NDA resubmission for sovleplenib for second-line ITP is planned in the first half of 2026. HUTCHMED currently retains all rights to sovleplenib worldwide. About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: www.hutch-med.com or follow us on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including its expectations regarding the therapeutic potential of sovleplenib for the treatment of wAIHA and the further development of sovleplenib in this and other indications. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the timing and outcome of clinical studies and the sufficiency of clinical data to support a new drug application submission of sovleplenib for the treatment of wAIHA or other indications in China or other jurisdictions, its potential to gain approvals from regulatory authorities on an expedited basis or at all, the efficacy and safety profile of sovleplenib, HUTCHMED’s ability to fund, implement and complete its further clinical development and commercialization plans for sovleplenib and the timing of these events. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. CONTACTS ______________________________ REFERENCES 1 Eaton WW, Rose NR, Kalaydjian A, Pedersen MG, Mortensen PB. Epidemiology of autoimmune diseases in Denmark. J Autoimmun. 2007; 29 (1):1-9. doi: 10.1016/j.jaut.2007.05.002. 2 Roumier M, Loustau V, Guillaud C, et al. Characteristics and outcome of warm autoimmune hemolytic anemia in adults: new insights based on a single-center experience with 60 patients. Am J Hematol. 2014; 89 (9):E150-5. doi: 10.1002/ajh.23767. 3 Cotran Ramzi S, Kumar Vinay, Fausto Nelson, Nelso Fausto, Robbins Stanley L, Abbas Abul K. Robbins and Cotran pathologic basis of disease. St. Louis, Mo: Elsevier Saunders; 2005. p. 637. 4 Gehrs BC, Friedberg RC. Autoimmune haemolytic anemia. Am J Hematol. 2002; 69:258–271. doi: 10.1002/ajh.10062. 5 Zhao X, Sun J, Zhang Z, et al. Sovleplenib in patients with primary or secondary warm autoimmune haemolytic anaemia: results from phase 2 of a randomised, double-blind, placebo-controlled, phase 2/3 study. Lancet Haematol. 2025;12(2):e97-e108. doi:10.1016/S2352-3026(24)00344-2 6 Barros MM, Blajchman MA, Bordin JO. Warm autoimmune hemolytic anemia: recent progress in understanding the immunobiology and the treatment. Transfus Med Rev. 2010; 24(3):195‐210. doi: 10.1016/j.tmrv.2010.03.002. 7 Barcellini W, Fattizzo B, Zaninoni A. Current and emerging treatment options for autoimmune hemolytic anemia. Expert Rev Clin Immunol. 2018; 14(10):857‐872. doi: 10.1080/1744666x.2018.1521722. 8 Davidzohn N, Biram A, Stoler‐Barak L, Grenov A, Dassa B, Shulman Z. SYK degradation restrains plasma cell formation and promotes zonal transitions in germinal centers. J Exp Med. 2020; 217(3):e20191043. doi: 10.1084/jem.20191043.