ZLAB

Study met primary endpoint of mean Total Improvement Score (TIS) at Week 52 in the combined study population of IMNM and DM patients (p=0.0011) Patient improvements observed early and sustained throughout study; consistent treatment effect across IMNM and DM First Phase 3 study to show statistically significant and clinically meaningful improvements in disease activity in IMNM, a subtype with no approved therapy SHANGHAI & CAMBRIDGE, Mass. & AMSTERDAM, August 17, 2026--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) and argenx (Euronext & NASDAQ: ARGX), today announced positive topline results from the ALKIVIA Phase 3 study evaluating VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in adults with autoimmune myositis. Study met its primary endpoint (p=0.0011) In the combined immune-mediated necrotizing myopathy (IMNM) and dermatomyositis (DM) population, patients treated with efgartigimod demonstrated statistically significant and clinically meaningful 15.4 point greater improvement in mean Total Improvement Score (TIS) at Week 52 versus placebo (47.95 vs 32.56). Rapid and sustained treatment benefit In the combined population, patients treated with efgartigimod consistently showed improvements over placebo starting at Week 4 that were statistically significant and sustained through the full year of treatment, even with steroid tapering. Magnitude of clinical improvement consistent across both IMNM and DM In prespecified subtype analyses, the primary endpoint of Mean TIS at 52 weeks was also met in IMNM patients treated with efgartigimod (p=0.0048), with a 14.8 point greater improvement over placebo (45.05 vs 30.24). In DM, a similar clinically meaningful improvement of 14.5 points (p=0.1093) was observed (51.51 vs 36.96), though statistical significance was not reached in this smaller cohort. Clinical impact observed in both muscle and skin measures In both IMNM and DM, all six core set measures of TIS contributed to the treatment effect, each favoring efgartigimod over placebo, spanning muscle strength, everyday physical function, and disease activity beyond the muscle. In DM, improvement in skin disease activity was also observed. Efgartigimod was well-tolerated by patients in the ALKIVIA study. The observed safety profile was consistent with prior studies and the known safety profile of efgartigimod. "The Phase 3 ALKIVIA results demonstrate a clinically meaningful and statistically significant treatment benefit in the overall study population, including a significant improvement in patients with IMNM, a subtype with no approved therapies," said Rafael G. Amado, M.D., President, Head of Global Research and Development at Zai Lab. "For patients in China living with autoimmune myositis, these results offer hope for a new targeted treatment option that could meaningfully improve muscle strength, physical function and other manifestations of this debilitating disease. Zai Lab is proud to have participated in this global trial and looks forward to working with argenx to bring this therapy to patients in China as quickly as possible." "For decades, people living with autoimmune myositis have relied on corticosteroids and broad immunosuppression, and those with IMNM have had no approved option at all. These are the first Phase 3 results to show that precision targeting of FcRn with efgartigimod can deliver meaningful benefit in this disease," said Luc Truyen, M.D., Ph.D., Chief Medical Officer at argenx. "The patient response to efgartigimod was durable and multidimensional: separation from placebo emerged early and held through a full year of treatment, with a treatment effect of comparable magnitude in IMNM and DM. This confirms that pathogenic IgG autoantibodies are key drivers of autoimmune myositis. We are grateful to the patients, caregivers, and investigators who made this pioneering study possible." "For people living with myositis, the goal is straightforward: regain strength and function, and get off long-term steroids. Until now we have had limited targeted therapies to offer patients," said Rohit Aggarwal, M.D., M.S., Professor of Medicine and Co-Director of the Myositis Center at the University of Pittsburgh, and an ALKIVIA investigator. "IMNM is the most refractory form of this disease and many of these patients carry irreversible muscle damage, which makes meaningful improvement genuinely difficult to achieve. That is what makes these results so compelling and groundbreaking. In DM, the magnitude of improvement was comparable – and for a community where treatment options remain limited and the burden of chronic steroids is just as heavy, that matters. Together these results tell us that reducing pathogenic autoantibodies is clinically meaningful and a major step forward for patients who are in need of a targeted treatment." Detailed results from the ALKIVIA study will be presented at an upcoming medical meeting. Efgartigimod continues to be evaluated as a potential treatment in other autoimmune rheumatologic diseases, including Sjögren’s disease and systemic sclerosis. About the ALKIVIA Study The ALKIVIA study was a global, randomized, double-blind, placebo-controlled, multicenter, operationally seamless Phase 2/3 study of efgartigimod SC for the treatment of autoimmune myositis across IMNM, DM and PM. The ALKIVIA study enrolled 264 patients who had active disease and were on background treatment. Participants were randomized (1:1) to receive weekly injections of efgartigimod PH20 SC or matched placebo PH20 SC. The study was conducted in two phases, with an analysis of the Phase 2 portion of the clinical trial after the first 89 patients completed the study, followed by Phase 3. The Phase 3 study enrolled 175 patients and included a protocol-mandated corticosteroid taper throughout the study. The primary endpoint of Phase 3 was the mean Total Improvement Score (TIS) at the end of the treatment period of 52 weeks of all treated patients compared to placebo. Prespecified analyses evaluated the combined IMNM and DM population and each subtype separately. argenx has an exclusive license agreement with Zai Lab for the development and commercialization of VYVGART and VYVGART Hytrulo in Greater China. Through this agreement, Zai Lab recruited Chinese patients into the ALKIVIA trial. About Autoimmune Myositis Autoimmune myositis is a heterogenous disease spectrum with autoimmune-mediated pathophysiology, characterized by chronic inflammation and progressive muscle weakness, and in some subtypes by skin involvement and other extramuscular manifestations. Proximal muscle weakness is a hallmark clinical feature across subtypes. Approximately 100,000 people in the United States live with autoimmune myositis, including approximately 20,000 with IMNM and approximately 40,000 with DM. Up to 80 percent of patients report long-term disability despite treatment. There are currently no targeted treatments available, and care relies primarily on corticosteroids and broad immunosuppressants, which are associated with significant cumulative toxicity, including metabolic, cardiovascular, musculoskeletal and infectious complications. Advances in the understanding of autoimmune myositis biology have highlighted the central role of antibody-mediated immunity, with pathogenic IgG autoantibodies contributing to muscle fiber damage and extramuscular manifestations across subtypes. FcRn maintains circulating IgG levels by recycling IgG antibodies, including pathogenic autoantibodies. Efgartigimod is designed to selectively block FcRn, reducing pathogenic IgG autoantibodies while preserving other aspects of immune function. About VYVGART VYVGART® (efgartigimod alfa fcab) is a first-in-class human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG autoantibodies. VYVGART Hytrulo® is a subcutaneous combination of efgartigimod alfa (VYVGART) and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology to facilitate subcutaneous injection delivery of biologics. VYVGART is approved for generalized myasthenia gravis (gMG) and immune thrombocytopenia (Japan only). VYVGART Hytrulo is approved for gMG and chronic inflammatory demyelinating polyneuropathy (CIDP). VYVGART Hytrulo may be marketed under different proprietary names in other regions. About Zai Lab Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health. For additional information about Zai Lab, please visit www.zailaboratory.com or follow us at https://x.com/ZaiLab_Global. About argenx argenx is a global immunology innovation company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker and is evaluating its broad potential in multiple serious autoimmune diseases while advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit www.argenx.com and follow us on LinkedIn, Instagram, Facebook, and YouTube. Zai Lab Forward-Looking Statements This press release contains forward-looking statements about future expectations, plans, and prospects for Zai Lab, including, without limitation, statements regarding the prospects of and plans for development and commercialization of efgartigimod in Greater China, the safety and efficacy of efgartigimod, and the potential treatment of patients with autoimmune myositis and other autoimmune disorders in Greater China. These forward-looking statements may contain words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "plan," "possible," "potential," "will," "would," and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact or guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business initiatives, (3) the results of clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) risks related to doing business in China, and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission (SEC). We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Our SEC filings can be found on our website at www.zailaboratory.com and the SEC’s website at www.sec.gov. This press release contains inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation (Regulation 596/2014). View source version on businesswire.com: https://www.businesswire.com/news/home/20260817193010/en/ Contacts For more information, please contact:Zai Lab Investor Relations: Christine Chiou / Cyan Liu+1 (917) 886-6929 / +86 195 3130 [email protected] / [email protected] Zai Lab Media: Shaun Maccoun / Xiaoyu Chen+1 (857) 270-8854 / +86 185 0015 [email protected] / [email protected] argenx Media Contact: Colin [email protected] argenx Investor Contact: Alexandra [email protected]

Image source: The Motley Fool. Thursday, Aug. 6, 2026 at 8:00 a.m. ET Founder, CEO and Chairperson - Dr. Samantha Du President and Head of Global Research and Development - Dr. Rafael Amado Chief Financial Officer - Dr. Yajing Chen Senior Vice President of Investor Relations - Christine Chiou Chief Business Officer - Dr. Shan He Operating Partner - Dr. Yizhe Wang Operator: Hello, ladies and gentlemen. Thank you for standing by, and welcome to Zai Lab's Second Quarter 2026 Financial Results Conference Call. [Operator Instructions] As a reminder, today's call is being recorded. It is now my pleasure to turn the floor over to Christine Chiou, Senior Vice President of the Investor Relations. Please go ahead, ma'am. Christine Chiou: Thank you, operator. Hello, and welcome, everyone. Today's earnings call will be led by Dr. Samantha Du, Zai Lab's Founder, CEO and Chairperson. She will be joined by Dr. Rafael Amado, President and Head of Global Research and Development; and Dr. Yajing Chen, Chief Financial Officer. Dr. Shan He, our Chief Business Officer; and Dr. Yizhe Wang, our operating partner, will also be available to answer questions during the Q&A portion of the call. As a reminder, during today's call, we will be making certain forward-looking statements based on our current expectations. These statements are subject to numerous risks and uncertainties that may cause actual results to differ materially from what we expect due to a variety of factors, including those discussed in our SEC filings. We will also refer to adjusted loss from operations, which is a non-GAAP financial measure. Please refer to our earnings release furnished with the SEC on August 6, 2026, for additional information on this non-GAAP financial measure. At this time, it is my pleasure to turn the call over to Dr. Samantha Du. Ying Du: Thanks, Christine. Good morning, and good evening, everyone. Thank you for joining us today. Zai Lab has reached an important inflection point in its evolution from a regional business into a global biopharmaceutical company. We built this company by bringing first or best-in-class medicines to patients in China. Today, we are developing our own innovative medicines for patients worldwide with our first U.S. regulatory submission expected next year. The transformation reflects the R&D capabilities we have built. We're conducting global multiple center registrational oncology trials, advancing additional clinical programs across oncology and immunology and advancing our preclinical pipeline into INDs this year. Zoci, our potential first and best-in-class DLL3 ADC demonstrates what Zai Lab is capable of. We advanced it from IND to global pivotal trials in less than 2 years, reflecting the speed and efficiency of the integrated development organization we have built. By the end of this year, we expect to have 3 registrational programs in small cell lung cancer and neuroendocrine carcinoma. We're also evaluating Zoci in combination with T cell engagers through collaborations with Amgen and Boehringer Ingelheim. Our second major global opportunity is ZL-1503, a potential first-in-class long-acting IL-13L-31 bispecific for atopic dermatitis. We believe it has the potential to bring together multiple attributes in a single asset, robust skin clearance, rapid and durable reduction and longer dosing interval. Later this year, we'll report the program's first human data. At the same time, we continue to strengthen our commercial business. This quarter, we sharpened our focus behind our highest priority brands. Net product revenue grew 11% versus previous quarter, and the business remained commercially profitable. We're setting a strong foundation and expect a return to meaningful year-on-year growth in 2027, followed by the potential for our first U.S. product launch in 2028. Zai Lab's evolution into a global biopharmaceutical company is well underway with a growing portfolio of globally developed differentiated medicines and a profitable commercial business. We're confident in the path ahead and the long-term value we can create for shareholders and patients. With that, let me turn the call over to Rafael to further discuss our pipeline in greater detail. Thank you. Rafael Amado: Thank you, Samantha. Let me walk you through the pipeline and what to expect this year. Starting with Zoci, our DLL3 targeted ADC. Small cell lung cancer is one of the most difficult diseases in oncology, and Zoci has demonstrated what we believe is a potential best-in-class ADC profile. In patients who have failed frontline multiple lines of treatment, we're seeing strong responses, including high responses and control of brain metastases. That efficacy with a favorable safety profile positions Zoci as a backbone for future combination regimens across lines of therapy. This program is moving fast. Our global registration Phase III in second-line plus small cell lung cancer is expected to complete enrollment in the first half of 2027 with a U.S. accelerated approval submission expected to follow later that year and approval anticipated in 2028. At ESMO in October, we will present combination data evaluating Zoci plus PD-L1 with or without chemo in first-line small cell lung cancer or during maintenance. Today's standard of care of IO plus chemo delivers a 60% to 70% response rate, median PFS of about 5 months and grade 3 or higher treatment-related adverse events around 60%. NCCN guidelines recommend 4 cycles of platinum-based chemotherapy. A chemo-sparing regimen could offer better tolerability, allow longer treatment duration compared to systemic chemotherapy and improved control of brain metastases. This is the basis of our Phase III combination strategy with immunotherapy, which we have discussed with regulators. We anticipate initiating the trial in the coming months. And in extrapulmonary neuroendocrine carcinomas where there is no established standard of care in the second line and beyond, Zoci demonstrated a confirmed ORR of 38.2%, which is well above the roughly 18% seen with currently used regimens. We're engaging with regulators on a potential approval pathway using extended single-arm data from our ongoing second-line trial with a subsequent approval pathway in first line. So 3 registrational programs underway by year-end. We're also collaborating with Amgen and Boehringer Ingelheim to combine Zoci with T cell engagers. A global Phase Ib study with Amgen is already enrolling, including a cohort of untreated small cell lung cancer patients on a triple combination of Zoci, IMDELLTRA and Imfinzi. And the global Phase Ib/II study with Boehringer Ingelheim in neuroendocrine carcinoma is expected to initiate in the coming months. Beyond Zoci, our next wave of global assets is advancing quickly. ZL-1503 is a long-acting humanized IgG1 bispecific antibody targeting both interleukin-13 and interleukin-31 receptor alpha. It includes YTE amino acid modifications in the Fc region that extend serum half-life and support less frequent dosing. Through blocking both pathways at once, ZL-1503 is designed to break the itch scratch inflammation cycle with rapid durable efficacy and less frequent dosing in moderate to severe atopic dermatitis. ZL-1503 is in the clinic now with first-in-human data in healthy volunteers to be presented in the second half of this year. This data set will include pharmacokinetic data following single dose administration and pharmacodynamic data, including inhibition of AD-related biomarkers such as pSTAT6, TARC and CCL26, a cytokine that recruits eosinophils during type 2 inflammation. We will also have an initial read on safety and immunogenicity, including assessment of antidrug antibodies. We're also currently enrolling patients with AD in the multiple ascending dose portion of the trial, and we will share this data at a major medical conference next year. We believe ZL-1503 with a potentially differentiated profile can address unmet medical needs in one of the largest markets in immunology globally, and we are moving this program forward rapidly. Beyond its lead indication, ZL-1503 has the potential to expand into additional IL-13 and IL-31 mediated diseases, creating a broader development opportunity over time. We look forward to sharing updates as the program advances. I would highlight just 2 more programs, ZL-6201, our internally discovered LRRC15 targeting ADC. We are actively enrolling patients in the global Phase I study and expect to complete enrollment in the dose escalation portion with initial data expected in the first half of next year. By year-end, we expect to submit an IND for ZL-1311, a next-generation T-cell engager targeting mucin 17, a promising target for gastrointestinal cancers. In summary, we have the infrastructure and capacity to advance multiple global programs at different stages of development simultaneously at speed and efficiency and across geographies while also advancing our regional pipeline. We have significant data emerging throughout the year on our most advanced products, and I look forward to sharing it with you in the coming months. And with that, I'll hand it over to Yajing. Yajing Chen: Thank you, Rafael. As Samantha and Rafael described, Zai Lab is entering the next phase of its evolution. From a financial perspective, our objective is straightforward, build on our commercially profitable business while investing with discipline behind the innovation that will drive our next stage of growth. In the second quarter, net product revenue grew 11% sequentially to $105.8 million, and the business remained commercially profitable. ZEJULA was steady. VYVGART volumes grew double digits sequentially. XACDURO demand remains strong despite supply constraints and KarXT's launch is off to an excellent start. In the second half of the year, we expect to further stabilize product sales while laying the foundation for a return to a meaningful growth in 2027. KarXT is expected to be a key driver of that growth as the first new mechanism of action for schizophrenia in decades with efficacy across positive and negative symptoms, no boxed warning and inclusion in national treatment guidelines, we believe KarXT is well positioned to address a significant unmet need. Early physician interest and positive patient experiences are encouraging, and we are building good momentum ahead of potential NRDL inclusion in 2027. For the VYVGART franchise, we intend to seek NRDL inclusion for VYVGART Hytrulo and are preparing for a gradual transition from IV to subcu. As a result, reported revenue in the second half may not fully reflect underlying demand due to timing of NRDL-related commercial dynamics. Looking ahead to 2027, we are confident in a return to meaningful growth, supported by new product launches, potential NRDL product inclusion and continued demand growth across our key brands. Beyond 2027, we expect our internally developed pipeline to become an increasingly important contributor to both revenue and margins. On expenses, we remain disciplined, prioritizing our highest value programs while improving productivity through streamlining the organization and the use of AI across clinical development, regulatory, commercial and corporate functions. As a result, we expect operating expenses to remain broadly stable through the remainder of the year. We ended the quarter with $717.5 million in cash, providing the financial flexibility to continue investing in the highest value opportunities. Pulling this together, we have a commercially profitable business, disciplined capital allocation and a global innovative pipeline that will increasingly shape the company's future growth and drive substantial value for patients and shareholders alike. With that, I will open it up for questions. Operator: [Operator Instructions] We will now take our first question from the line of Anupam Rama from JPMorgan. Anupam Rama: Just looking to ESMO, can you walk us through what you're looking for in the first-line small cell study of Zoci plus IO plus or minus chemo? Like what's going to be the size and scope of that data set? And how are you defining a win scenario? Christine Chiou: Thank you, Anupam. This is Christine. Rafael, could you take that question, please? Rafael Amado: Sure. So at ESMO, we expect to present about 60 patients worth of data. This will include doublet and triplet, but most patients will be in the doublet with a checkpoint inhibitor at the highest dose of 1.6 milligrams per kilogram. We have been monitoring that data. We think we'll be fairly mature by the time of ESMO with a median follow-up between 8 or 9 months. So we will be able to report on a meaningful data set by then. In terms of what to look for, I think the benchmark with the checkpoint inhibitor studies have shown responses in the 60% to 70% with chemotherapy and median follow-up -- sorry, progression-free survival of about 5 months. So there's still room for improvement in the about 80% response rate or so and a 50% increase in median PFS would be, I think, clinically meaningful. So those are sort of the parameters that we're looking for. We're obviously at the same time that we're preparing this data set moving forward with operationalizing the study. And it's going to be a chemo-sparing study, not because we saw any DLTs with the triplet, but because we think it's more convenient, and we will be able to give higher dose intensity of Zoci than chemotherapy does. Operator: And the next question comes from Michael Yee from UBS. Kaiyue Yang: This is Kyle Yang for Michael. Two for us. The first one on the higher level, the company previously guided toward profitability by end of 2025. So how should we think about that? And at what point do you think investors can start to revisit the profitability goal? The second question is on IL-13, IL-31. The atopic dermatitis landscape is getting increasingly competitive. And we recently saw additional investor interest in the space, including a new IPO this week also has -- that also has an IL-13, IL-31. So how should we think about the differentiation of your asset versus your competitors? Christine Chiou: Thank you, Kyle. Yajing, can you please take the one on profitability and Rafael, a question on the 1503 differentiation, please? Yajing Chen: All right. Thanks for the question. So I'm really looking at the profitability through the lens of our capital allocation. So we already have a commercially profitable business today. Our local manufacturing is on track for XACDURO and KarXT that will continue to improve our profitability. However, at the same time, we have multiple global competitive programs that we believe have the potential to create substantially greater long-term value. So right now, our responsibility is to invest where the returns justify it. We do maintain a very high bar for every investment decision. So in summary, we are kind of growing revenue with our potential global approval in 2028, which will improve margin and drive operating efficiencies across the organization at the same time. So we believe those factors adding together will naturally lead to the profitability over time and continue to improve the profitability over time as well. Rafael Amado: Yes. This is Rafael. I'll just make a few comments about 1503. So the drug, as you know, is designed to have 3 highly desirable attributes. The first one was robust skin clearance. And I think this is through Th2 suppression, but by breaking the cycle of itching, scratching and inflammation that we see. I think by inhibiting the receptor, the 31 receptor, we should see brisk reduction in pruritus. We also have a molecule that is YTE modified, the extended dosing interval that's going to be tested in the current study that is ongoing, both in healthy volunteers and MADs, but we expect that it will be superior to the standards at the moment with every 1 month and dupi every 2 weeks. So we expect to go beyond that. And there are a few agents that actually have the 3 simultaneous attributes. Some of them are preclinical. Some of them are targeting the ligand, some of them are targeting the receptor. We believe that targeting IL-13 ligand and targeting 31 receptor, the YTE modification will result in both better reported outcomes with regards to pruritus, which is really morbid in these patients, but also improvement in inflammation. And also, this is an underpenetrated market where there isn't really a winner takes all, if you will. So I think any improvement in quality of life, dose extension and more importantly, inflammation and patient symptoms will allow for these drugs to have a role in atopic dermatitis. So we're also moving very fast with the Phase I study, and we expect to, as we've guided before, present healthy volunteers data this year and then next year, the MAD data in atopic dermatitis. So we are a bit ahead of some of the competitors. Operator: We will now take our next question from Li Watsek from Cantor. Li Wang Watsek: I have one pipeline and one commercial question. For 1503, the bispecific antibody, just wondering what is the potential dosing profile that you're looking for? And how would the SAD data later this year inform you on the drug profile? Any early trends on ADA from the MAD cohort? And the second question is on the commercial side. Just at a high level, how do you envision the China business to evolve in the coming quarters? What are the metrics that are most important to you? Christine Chiou: Thank you, Li. Rafael, can you take the question on the dosing profile for 1503 and how the upcoming data will inform on the profile and on ADA. And then Yizhe, if you can address the commercial question. Rafael Amado: Yes. So in the healthy volunteers data, it's a single IV injection, and we have 6 cohorts. We're testing 4 doses. The single injections and the patients are being followed long term. This will inform us mostly on tolerability and PK, including half-life and then the biomarkers that I mentioned in the prepared remarks, including immunogenicity of antidrug antibodies. The MAD has 2 cohorts with 2 doses, also IV, and it's a larger cohort. I think to hone into the dose, we will need to do a bit more experimentation. There's a bioequivalence study that will compare the IV to the subcu and then we will do more dose experimentation with the subcutaneous dose. We expect that there will be a short induction course followed by a longer maintenance dosing, but it's premature to speculate on the actual dose. So -- and on the question about antibody drug conjugates, obviously, we're looking at this, and we will be reporting on this suffice it to say that the study continues. Yizhe Wang: Okay. Li, and hi, everybody. This is Yizhe here, and I'm speaking with you in China right now. Can you hear me okay? Good signal? Christine Chiou: Yes. Yizhe Wang: Very good. Great. Okay. So commercial. So first of all, I just want to say 3 months in a row, I look at commercial, it's not just a China business only, right? If you look out 3-year horizon, we have the potential to launch our first U.S. assets, our global assets, very exciting. That is Zoci. But that being said, the near term, absolutely, our focus should be focusing on our regional business, which is primarily our China business. So my view is this, we actually have a pretty sizable business, okay, but with a diverse, right, mix. Some are CSO products, some are promoted by our own sales. So from my perspective, it's very important going forward to be very focused focus on 3 key brands. That is return ZEJULA to growth and continue growth on the volume growth, underlying demand on efgart and also launch excellence for KarXT, okay? From execution front, we must go back to the basics. We have to be very good at, I call it brilliant at the basics, really drive the metrics. So you asked me about what are some of the potential KPIs. So it's all about underlying demand. So for example, for each of these brands, new patient start will be critically important. We like to see the signal continue. For those who flatten, we want to return to growth. And for those has been growing, we want to continue to grow or potentially accelerate. We have seen these signals, right? And that will lead to, I think, in the next couple of quarters, a consolidation or solidification of our stabilization of revenue and eventually turning to a very meaningful growth in 2027, okay? So that is where we are. So in the second -- in the upcoming quarter, I look for is -- as you see the second quarter, we actually delivered an 11% sequential quarter-over-quarter growth. So in the upcoming quarter, we -- I see quite confidently we can solidify that. And then really -- in the meantime, really improving our underlying demand and setting ourselves up for a very good next year. And during this period, we also will focus on a couple of NRDL, right, negotiations. We want to make sure we win and we win at a good price. Operator: Our next question comes from the line of Yigal Nochomovitz from Citi. Unknown Analyst: This is [ Caroline ] on for Yigal. We're wondering as your MUC17 T cell engager approaches the clinic, what aspects of the preclinical profile give you the greatest confidence it can overcome historical challenges associated with T cell engagers in solid tumors? Christine Chiou: Rafael, if you can take the MUC17 T Cell. Rafael Amado: Sure. Yes. This is MUC17 T cell engager. It's an interesting target. It's in GI tumors, more prominently in gastric, pancreas and other tumors of the GI tract. It is engineered to be biparatopic. So it targets more than one epitope. So hopefully, the avidity will be higher. But the CD3 is balanced by higher on and off rate. And we believe that, that hopefully, in the clinic will ameliorate cytokine release syndrome, which is really the Achilles heel of these products and that they need to be given in the hospital because of the emergence of CRS. So a lot of the innovation in this field, as you probably know, is directed to increasing efficacy, but also decreasing the potential toxicity related to CRS so that eventually one day, these products can be given in the community. We can say that preclinically, as we prepare to the IND, the product looks really to have great properties compared to other potential products in this target, including competitors. So we're pretty excited about it, and we're moving forward with the goal of having this IND out by the year's end. Operator: We would now take our next question from Daina Graybosch from Leerink Partners. Daina Graybosch: I wonder if you can talk about the combination of your DLL3 ADC with the DLL3 targeted T cell engager and sort of mechanistically and biologically why that has value or differentiation relative to combining a DLL3 T cell engager with the B7-H3 ADC? Christine Chiou: Thank you, Daina. It's great to have you on the call. Rafael, can you address the question on the combo of DLL3 plus TCE and why it may have value and differentiation versus the B7-H3 combo? Rafael Amado: Yes. I mean the more simplistic reason is that the mechanisms of action are orthogonal. They are very different. One is a cytotoxic that can debulk tumors, particularly small cell lung cancer that can present with a high-volume disease and then allow T cells to eliminate residual disease and maintain immune surveillance. As the ADC kills the tumor cells, it liberates other antigens that are neoantigens. And the T cells, even though they're directed to DLL3, can respond to these neoantigens, particularly when they're combined with PD-1. So this is a combination which is really targeted to bring in cytotoxicity as well as IO into the tumor. In the case of Zoci and IMDELLTRA, for instance, the epitopes are different. So both drugs can actually bind in the same cell. And it's known that the density of receptors are required for ADCs and TCEs are different. ADCs combine even if there are lower receptors because there's also a bystander effect that can affect cells that have low DLL3 expression. So this is something, obviously, that still needs to be proven. We're doing the studies and the studies are aimed to look at tolerability. The good news is that there aren't really overlapping toxicities, except for potentially myelosuppression. And with regards to whether DLL3 is the same -- is the best target because it's the same target, there's a B7-H3 study that Amgen was conducting. It is on pause at the moment with IMDELLTRA as well. B7-H3 is not a tumor-specific target. It's present in normal tissue, including the lung epithelium. So there's a potential for more toxicity and in small cell lung cancer patients, lung toxicity can be problematic because of the incidence of ILD with ADCs. So we think that having a safer target that is more tumor specific is probably a better option. So we're looking forward to seeing the results of these combinations. Amgen obviously has data with B7-H3, but that hasn't been released. And we look forward to looking at the dual -- DLL3 dual mechanism approach. And hopefully, we'll have that data early next year. Operator: [Operator Instructions] We will now take our next question from the line of Linhai Zhao from Goldman Sachs. Linhai Zhao: This is Linhai from Goldman. Just a follow-up question on the Zoci and DLL3-TCE combinations. We've seen that both Amgen and BI have initiated the Phase I/II trials, including different cohorts for both the late line and first line. And for the RP2D in first-line triplet exploration, wondering if the RP2D will still remain as 1.6 mg or there will be a dose titration to a different dose level? And for the 2 Phase I/II trials, what might be the expected time that we will see some data? Christine Chiou: Thank you, Linhai. Rafael, could you address the question on the RP2D dose for the Zoci plus T cell engagers study? Rafael Amado: Yes. So the 2 immunotherapies, the PD-L1 as well as the T cell engager will be used as standard doses. There may be some accommodation to be able to dose every 3 weeks just because Zoci is dosed every 3 weeks. With regards to Zoci, we're only exploring 2 doses and moving very fast. We're exploring 1.2 and 1.6 milligrams per kilogram. We don't have any reason to think that 1.6 won't be well tolerated. So we hope that, that will be the dose that we go on to expand. So that's as much as we can say. The study is ongoing. The Amgen one is ongoing and accruing well. And it's got a cohort of patients that are untreated, which I think is probably the most exciting cohort. As you know, the response rate with T cell engagers is relatively modest. It's in the 30% to 40%, whereas the response rate with ADCs is very high. So you combine also differential response rates, differential durability of response and then a potential immune surveillance that in Phase III studies with T cell engagers, particularly with IMDELLTRA in second line has led to a 6-month difference in survival. So again, mechanistically, this makes a lot of sense. And in terms of the doses, we hope that we won't have to modify our target dose that we have chosen across the development plan for Zoci, which is 1.6 mgs per kg. Linhai Zhao: And when will we see the data readouts from the trial? Rafael Amado: With the drug being operationalized by Amgen, so even though we obviously work very closely with them, it will be probably a joint decision, but they will take the lead as to when those results will be presented. My sense is that it will be next year, but I can't tell you exactly when it will happen. I would probably guide towards the end of the second half of the year. Operator: I am showing no further questions. I'll now turn the conference back to Dr. Samantha Du for her closing comments. Ying Du: Thank you, operator. I want to thank everyone for taking the time to join us on the call today. We appreciate your support and look forward to updating you again after the third quarter of 2026. Operator, you may now disconnect this call. Operator: Thank you for your participation in today's conference. This does conclude the program. You may now disconnect your lines. Before you buy stock in Zai Lab, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Zai Lab wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. 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As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Zai Lab (ZLAB) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Never miss an important update on your stock portfolio and cut through the noise. Over 7 million investors trust Simply Wall St to stay informed where it matters for FREE. Zai Lab (ZLAB) stock is in focus after the company reported second quarter 2026 results, including revenue of US$106.31 million and a net loss of US$50.83 million, with wider losses than a year earlier. See our latest analysis for Zai Lab. The earnings release seems to have shifted sentiment toward Zai Lab in the short term, with an 11.69% 1 day share price return and a 27.64% 7 day share price return. However, the 1 year total shareholder return is still down 33.30%, which points to short term momentum against a weaker long term record. If this kind of rapid move has you looking beyond a single stock, it could be a good moment to see what else is setting up in AI focused healthcare using the 43 healthcare AI stocks. Given Zai Lab's sharp recent rebound alongside ongoing losses, some investors see a turnaround in progress while others view the move as fragile. Which case lines up better with what the current valuation suggests should happen next? With Zai Lab last closing at $23.32 against a most followed fair value estimate of $33.30, the current price sits well below that narrative view of worth. Read the complete narrative. Want to understand why this narrative backs a higher value for Zai Lab? The story leans heavily on fast building revenue, rising margins, and a richer earnings profile. Curious which specific growth path and profitability shift underpin that fair value gap? The full narrative lays out the financial roadmap behind this valuation call. Result: Fair Value of $33.30 (UNDERVALUED) Have a read of the narrative in full and understand what's behind the forecasts. However, Zai Lab still faces meaningful risks, including competition in China that could pressure future revenue, as well as ongoing high R&D spending that may delay lasting profitability. Find out about the key risks to this Zai Lab narrative. The first narrative leans on a fair value of $33.30 for Zai Lab based on future earnings assumptions. Yet the SWS DCF model points to a future cash flow value of $91.16, which indicates the stock is trading well below that estimate. Which lens do you trust more when the gap is this wide? Look into how the SWS DCF model arrives at its fair value. Unsure which side of the Zai Lab story feels more convincing right now? Take a closer look at both the risks and potential rewards so you can weigh the 3 key rewards and 1 important warning sign If Zai Lab has your attention, do not stop there. Broaden your watchlist now so you are not relying on a single story when new opportunities appear. Target resilient cash generators by scanning companies with the solid balance sheet and fundamentals stocks screener (48 results). Hunt for potential mispricings by reviewing the 52 high quality undervalued stocks before prices move away from you. Spot possible under the radar opportunities early by checking the screener containing 21 high quality undiscovered gems. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include ZLAB. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

Interested in Zai Lab Limited Unsponsored ADR? Here are five stocks we like better. Q2 net product revenue rose 11% sequentially to $105.8 million, supported by VYVGART volume growth, steady ZEJULA sales, XACDURO strength and the early KarXT launch. Management expects revenue to stabilize in late 2026 before returning to meaningful year-over-year growth in 2027, with $717.5 million in cash at quarter-end. Zoci development is expanding toward potential U.S. approval. Zai Lab expects three registrational programs by the end of 2026, plans to complete a Phase III small-cell lung cancer enrollment in the first half of 2027 and anticipates a possible accelerated-approval filing later that year, with potential approval in 2028. The company continues advancing its global pipeline, including ZL-1503 for atopic dermatitis, ZL-6201 for solid tumors and ZL-1311 for gastrointestinal cancers. Zai Lab also expects its first U.S. regulatory submission next year as it transitions from a China-focused business into a global biopharmaceutical company. Zai Lab Stock Has Fallen to Value Levels Zai Lab (NASDAQ:ZLAB) said its second-quarter net product revenue rose 11% sequentially to $105.8 million as the company continued to invest in a pipeline it expects to support a transition into a global biopharmaceutical business. Founder, Chairperson and CEO Samantha Du said the company is advancing internally developed medicines for patients worldwide while maintaining a commercially profitable business in China. Zai Lab expects its first U.S. regulatory submission next year and cited the potential for its first U.S. product launch in 2028. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth “Zai Lab has reached an important inflection point in its evolution from a regional business into a global biopharmaceutical company,” Du said. Chief Financial Officer Yajing Chen said product revenue growth in the quarter was supported by double-digit sequential volume growth for VYVGART, continued steady performance from ZEJULA, strength in XACDURO despite supply constraints, and an “excellent” early launch for KarXT. → 4 Oil and Gas ETF Plays as Prices Stay Sky-High The company expects product sales to stabilize during the second half of 2026 before returning to what management described as meaningful year-over-year growth in 2027. Chen said KarXT is expected to be an important contributor, citing its status as a new mechanism of action for schizophrenia, its efficacy across positive and negative symptoms, the lack of a boxed warning and its inclusion in national treatment guidelines. Zai Lab also plans to pursue inclusion of VYVGART HYTRULO in China’s National Reimbursement Drug List, or NRDL, and is preparing for a gradual shift in the VYVGART franchise from intravenous administration to subcutaneous delivery. Chen cautioned that reported second-half revenue may not fully reflect underlying demand because of the timing of NRDL-related commercial dynamics. → Sandisk Just Delivered a Blowout Quarter—Here's Why the Stock Is Falling Operating Partner Yizhe Wang said the company’s near-term commercial priorities are returning ZEJULA to growth, sustaining underlying demand for VYVGART and executing the KarXT launch. He identified new patient starts as a key metric for the company’s major brands and said management aims to stabilize revenue over the next several quarters before pursuing stronger growth in 2027. Chen said Zai Lab is maintaining disciplined investment in higher-priority development programs while seeking productivity improvements through organizational streamlining and use of artificial intelligence across clinical development, regulatory, commercial and corporate functions. Operating expenses are expected to remain broadly stable for the rest of the year. The company ended the quarter with $717.5 million in cash. President and Head of Global Research and Development Rafael Amado outlined plans for zoci, the company’s DLL3-targeted antibody-drug conjugate, or ADC, in small cell lung cancer and neuroendocrine carcinoma. Zai Lab expects to have three registrational programs underway by the end of 2026 across small cell lung cancer and neuroendocrine carcinoma. Its global Phase III study in second-line and later small cell lung cancer is expected to complete enrollment in the first half of 2027. The company anticipates a U.S. accelerated-approval submission later that year and potential approval in 2028. At the European Society for Medical Oncology meeting in October, the company plans to present data from about 60 patients receiving zoci with a PD-L1 inhibitor, with or without chemotherapy, in first-line small cell lung cancer or maintenance treatment. Amado said most participants will have received the doublet regimen at zoci’s 1.6 mg/kg dose, and the data are expected to have a median follow-up of roughly eight to nine months. Management said existing immunotherapy-plus-chemotherapy regimens typically produce response rates of 60% to 70% and median progression-free survival of about five months. Amado said Zai Lab would view response rates around 80% and a 50% improvement in median progression-free survival as clinically meaningful. The company expects to initiate a Phase III chemo-sparing combination study in the coming months. In extrapulmonary neuroendocrine carcinoma, Amado said zoci produced a confirmed objective response rate of 38.2% in second-line and later treatment, compared with roughly 18% for currently used regimens. The company is discussing a possible approval pathway with regulators based on expanded single-arm data, followed by a potential first-line development path. Zai Lab is also collaborating with Amgen and Boehringer Ingelheim on zoci combinations with T-cell engagers. A global Phase Ib study with Amgen is enrolling, including untreated small cell lung cancer patients receiving zoci, IMDELLTRA and IMFINZI. A Phase Ib/II trial with Boehringer Ingelheim in neuroendocrine carcinoma is expected to begin in coming months. Amado said data from the Amgen-led combination program may be presented in the second half of 2027. The company’s other major global program is ZL-1503, a long-acting bispecific antibody targeting interleukin-13 and interleukin-31 receptor alpha for moderate-to-severe atopic dermatitis. Zai Lab expects to present first-in-human data from healthy volunteers in the second half of 2026, including pharmacokinetic, biomarker, safety and immunogenicity findings. The company is also enrolling atopic dermatitis patients in the multiple-ascending-dose portion of the study and expects to report those results at a medical conference next year. Amado said the program is designed to support robust skin clearance, rapid itch reduction and less frequent dosing, though he said it was premature to specify the eventual dose or dosing schedule. Elsewhere, Zai Lab is enrolling patients in a global Phase I trial of ZL-6201, an LRRC15-targeting ADC, with initial dose-escalation data expected in the first half of 2027. The company also expects to submit an investigational new drug application by year-end for ZL-1311, a next-generation MUC17-targeted T-cell engager for gastrointestinal cancers. Zai Lab Ltd (NASDAQ: ZLAB) is a biopharmaceutical company focused on the research, development, manufacturing and commercialization of innovative therapies. Headquartered in Shanghai, China, Zai Lab operates R&D centers in Asia and the United States and maintains commercial offices across Greater China, North America, Europe and Australia. The company's end-to-end platform encompasses discovery biology, translational development, clinical research and global supply chain management. The company's marketed portfolio is anchored by Brukinsa (zanubrutinib), a next-generation Bruton's tyrosine kinase inhibitor approved for several B-cell malignancies. 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 "Zai Lab Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

For the quarter ended June 2026, Zai Lab Limited Unsponsored ADR (ZLAB) reported revenue of $106.31 million, down 3.3% over the same period last year. EPS came in at -$0.46, compared to -$0.37 in the year-ago quarter. The reported revenue compares to the Zacks Consensus Estimate of $106.33 million, representing a surprise of -0.01%. The company delivered an EPS surprise of +19.3%, with the consensus EPS estimate being -$0.57. While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how they compare to Wall Street expectations to determine their next course of action, some key metrics always provide a better insight into a company's underlying performance. As these metrics influence top- and bottom-line performance, comparing them to the year-ago numbers and what analysts estimated helps investors project a stock's price performance more accurately. Here is how Zai Lab Limited performed in the just reported quarter in terms of the metrics most widely monitored and projected by Wall Street analysts: Product Revenue- ZEJULA: $32.08 million versus the two-analyst average estimate of $32.29 million. The reported number represents a year-over-year change of -21.8%. Product Revenue- OPTUNE: $12.2 million versus the two-analyst average estimate of $12.6 million. The reported number represents a year-over-year change of -1.2%. Product Revenue- QINLOCK: $9.59 million versus the two-analyst average estimate of $8.59 million. The reported number represents a year-over-year change of +12.4%. Product Revenue- NUZYRA: $17.1 million compared to the $17.36 million average estimate based on two analysts. The reported number represents a change of +19.6% year over year. Collaboration revenue: $0.56 million versus the two-analyst average estimate of $-0.67 million. Product Revenue- XACDURO: $7.96 million versus the two-analyst average estimate of $9.24 million. Product Revenue- AUGTYRO: $2.21 million compared to the $1.84 million average estimate based on two analysts. Product Revenue, net: $105.75 million compared to the $106.99 million average estimate based on two analysts. Product Revenue- VYVGART: $23.87 million compared to the $21.49 million average estimate based on two analysts. The reported number represents a change of -9.9% year over year. View all Key Company Metrics for Zai Lab Limited here>>> Shares of Zai Lab Limited have returned -7% over the past month versus the Zacks S&P 500 composite's +3.3% change. The stock currently has a Zacks Rank #3 (Hold), indicating that it could perform in line with the broader market in the near term. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Zai Lab Limited Unsponsored ADR (ZLAB) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

This article first appeared on GuruFocus. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Zai Lab Ltd (NASDAQ:ZLAB) has reached an inflection point, transitioning from a regional business into a global biopharmaceutical company with its first U.S. regulatory submission expected next year. The company's lead asset, ZL-1310 (DLL3 ADC), is advancing rapidly, with three registrational programs expected by year-end in small cell lung cancer and neuroendocrine carcinoma, and a potential U.S. approval anticipated in 2028. Net product revenue grew 11% sequentially in Q2 2026 to $105.8 million, and the commercial business remained profitable, with strong demand for key brands like VYVGART and a promising launch for COBENFY. The pipeline includes ZL-1503, a potential first-in-class bispecific for atopic dermatitis, which is advancing quickly with first-in-human data expected later this year and a differentiated profile targeting both IL-13 and IL-31 pathways. The company ended the quarter with a strong cash position of $717.5 million, providing financial flexibility to invest in high-value global programs while maintaining disciplined operating expenses. Zai Lab Ltd (NASDAQ:ZLAB) is executing on multiple global collaborations, including with Amgen and Boehringer Ingelheim, to explore combination therapies that could expand the utility of its DLL3 ADC. The company has deferred its previous profitability goal, indicating that operating expenses will remain broadly stable as it prioritizes investment in global pipeline programs over near-term profitability. Reported revenue in the second half of 2026 may not fully reflect underlying demand due to timing of NRDL-related commercial dynamics, particularly for the VYVGART franchise as it transitions from IV to SubQ. The competitive landscape for atopic dermatitis treatments is intensifying, with new entrants and increased investor interest in IL-13/IL-31 targeting assets, which could pressure ZL-1503's market potential. The company's commercial business in China faces challenges, including supply constraints for certain products and the need to stabilize sales before returning to meaningful growth in 2027. The DLL3 ADC combination studies with T-cell engagers are still early-stage, and data readouts are not expected until the second half of next year, leaving uncertainty around the ultimate efficacy and safety of these regimens. The company's transition to a global biopharmaceutical model involves significant execution risks, including the need to successfully complete global registration trials and navigate regulatory pathways in the U.S. Warning! GuruFocus has detected 7 Warning Signs with ZLAB. Is ZLAB fairly valued? Test your thesis with our free DCF calculator. Q: What should investors look for in the first-line small cell lung cancer data for ZL-1310 (DLL3 ADC) plus immunotherapy, with or without chemo, expected at ESMO?A: Dr. Rafael Amato, President and Head of Global R&D, stated that the ESMO presentation will include data from about 60 patients, mostly on the doublet regimen (DLL3 ADC plus checkpoint inhibitor) at the highest dose of 1.6 mg/kg. With a median follow-up of 8-9 months, the data will be mature. He defined a "win scenario" as achieving an 80% response rate (vs. 60-70% for standard of care) and a 50% increase in median progression-free survival (vs. ~5 months for chemo+IO). The upcoming Phase 3 will be a chemo-sparing study to allow for higher dose intensity and better tolerability. Q: How should investors think about the company's path to profitability, and how does ZL-1503 differentiate itself in the increasingly competitive IL-13/IL-31 space?A: CFO Yajing Chen explained that the company is prioritizing capital allocation toward high-return global programs over near-term profitability, but expects a natural path to profitability driven by revenue growth, the potential 2028 U.S. launch, and operational efficiencies. Dr. Amato added that ZL-1503 is designed with three key attributes: robust skin clearance via TH2 suppression, rapid pruritus reduction by blocking the IL-31 receptor, and extended dosing intervals due to YTE modifications. He believes this combination of attributes, along with the company's speed in clinical development, differentiates it from competitors in the atopic dermatitis market. Q: What is the potential dosing profile for ZL-1503, and how will the upcoming healthy volunteer data inform the program?A: Dr. Amato detailed that the Phase 1 healthy volunteer study involves single IV injections across six cohorts and four doses, focusing on tolerability, PK (including half-life), biomarkers (pSTAT6, TARC, CCL26), and immunogenicity (anti-drug antibodies). The multiple ascending dose (MAD) portion in atopic dermatitis patients has two cohorts. He noted that a future bioequivalence study will compare IV to subcutaneous administration, and expects a short induction course followed by longer maintenance dosing, though it's premature to speculate on the exact dose. Q: How will the China commercial business evolve in the coming quarters, and what are the key metrics to watch?A: Dr. Yizhe Wang, Operating Partner, emphasized a focus on three key brands: Nuzyra, Vyzulta, and Coxy. He stressed the importance of "brilliant at the basics," with new patient starts as a critical KPI for each brand. He expects the next couple of quarters to solidify revenue stabilization, leading to meaningful growth in 2027. He also highlighted the importance of successful NRDL (National Reimbursement Drug List) negotiations, aiming to "win at a good price." Q: What aspects of the preclinical profile of the MUC17 T-cell engager (ZL-1311) give confidence it can overcome historical challenges of T-cell engagers in solid tumors?A: Dr. Amato explained that ZL-1311 is a biparatopic T-cell engager targeting two epitopes on MUC17, which should increase avidity. Critically, it features a silenced CD3 domain with a higher on/off rate, designed to ameliorate cytokine release syndrome (CRS), a major hurdle for this drug class. He stated that preclinical data looks promising compared to competitors, and the company is on track to submit the IND by year-end. Q: What is the mechanistic rationale for combining a DLL3 ADC with a DLL3 T-cell engager, and how does it differ from combining with a B7H3 ADC?A: Dr. Amato explained that the mechanisms are orthogonal: the ADC debulks tumors and liberates new antigens, while the T-cell engager eliminates residual disease and maintains immune surveillance. He noted that DLL3 is a more tumor-specific target than B7H3, which is expressed in normal tissue like lung epithelium, potentially leading to more toxicity. He believes the dual DLL3 approach is safer and more effective, and expects initial data from the Amgen collaboration early next year. Q: What will be the RP2D for ZL-1310 in the combination studies with T-cell engagers, and when can we expect data?A: Dr. Amato stated that the immunotherapies (PD-1 and T-cell engager) will be used at standard doses, potentially adjusted for a 3-week dosing schedule to align with ZL-1310. For ZL-1310, the company is exploring 1.2 and 1.6 mg/kg doses, with the expectation that 1.6 mg/kg will be the expansion dose. He guided that data from the Amgen study, which is accruing well, will likely be presented in the second half of next year, though Amgen will lead the timing decision. Q: Can you provide an update on the financial performance and the outlook for the second half of 2026?A: CFO Yajing Chen reported Q2 net product revenue of $105.8 million, an 11% sequential increase, with the business remaining commercially profitable. She noted that Vyzulta volumes grew double-digits sequentially and Coxy's launch is off to an excellent start. For the second half, she expects revenue stabilization, with potential NRDL-related dynamics for Vyzulta potentially affecting reported revenue. Operating expenses are expected to remain broadly stable, and the company ended the quarter with $717.5 million in cash. Q: What is the status of the ZL-1310 registrational programs, and what are the next milestones?A: Dr. Amato confirmed that by year-end, the company expects to have three registrational programs for ZL-1310: a global Phase 3 in second-line plus small cell lung cancer (enrollment completion expected in H1 2027), a potential approval pathway in extrapulmonary neuroendocrine carcinomas using extended single-arm data, and a planned Phase 3 combination study with immunotherapy in first-line small cell lung cancer. He also mentioned ongoing collaborations with Amgen and Boehringer Ingelheim to evaluate combinations with T-cell engagers. Q: How is the company leveraging AI and organizational streamlining to improve productivity?For the complete transcript of the earnings call, please refer to the full earnings call transcript.

The Company advanced multiple global oncology and immunology programs toward key clinical and regulatory milestones, with significant pipeline catalysts expected in the second half of 2026 Global Phase 1 data for zocilurtatug pelitecan (zoci) in combination with a PD-L1 inhibitor in first-line SCLC to be presented at ESMO 2026; planned initiation of a registrational Phase 3 study later this year Registrational Phase 3 DLLEVATE study evaluating zoci in second-line plus SCLC remains on track, with enrollment expected to be completed in the first half of 2027, supporting a potential U.S. accelerated approval submission in 2027 Global Phase 1/1b study of ZL-1503, a potential first-in-class long-acting IL-13/IL-31Rα bispecific antibody for the treatment of atopic dermatitis, continues to advance, with initial first-in-human data expected in the second half of 2026 KarXT successfully launched in mainland China; encouraging early launch trends building momentum ahead of potential NRDL inclusion Total revenues of $106.3 million in the second quarter of 2026; net product revenue grew 11% versus prior quarter driven by stabilization of ZEJULA and double-digit volume growth for VYVGART; commercial business positioned for a return to meaningful growth in 2027 Conference call and webcast today, August 6, 2026, at 8:00 a.m. ET (8:00 p.m. HKT) SHANGHAI & CAMBRIDGE, Mass., August 06, 2026--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced financial results for the second quarter of 2026, along with recent product highlights and corporate updates. "Zai Lab is entering an exciting new chapter in our evolution," said Dr. Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab. "Over the past several years, we have evolved from bringing innovative medicines to patients in China to becoming a global biopharmaceutical company developing our own differentiated medicines for patients around the world. Today, our innovation pipeline is rapidly maturing. We advanced zocilurtatug pelitecan (zoci), our potential best-in-class DLL3 antibody-drug conjugate (ADC), from Investigational New Drug (IND) to global Phase 3 in under two years, and our growing portfolio of internally developed medicines, including ZL-1503, gives us confidence that innovation will increasingly drive Zai Lab's next phase of growth. Meanwhile, we continue to strengthen our commercial business. This quarter, we sharpened our commercial focus, delivered sequential revenue growth, maintained commercial profitability, and laid the foundation for a return to meaningful growth in 2027. Together, these achievements position Zai Lab to create long-term value for patients and shareholders." "We are excited about the progress across our growing global pipeline, with three registrational studies expected to be underway by year end and the potential for our first U.S. regulatory submission next year," said Rafael G. Amado, M.D., President, Head of Global Research and Development at Zai Lab. "Zoci has demonstrated a differentiated profile — strong systemic and intracranial activity with a favorable safety profile — that supports development across multiple treatment settings in small cell lung cancer (SCLC) and extrapulmonary neuroendocrine carcinomas (epNECs). In immunology, ZL-1503 has the potential to address both inflammation and itch through dual inhibition of IL-13 and IL-31. Combined with its extended half-life enabled by YTE modifications, we believe its differentiated profile has the potential to address significant unmet needs in one of the largest markets in immunology. We look forward to sharing important clinical updates for both programs in the second half of the year." Second Quarter 2026 Financial Results Total revenue was $106.3 million in the second quarter of 2026, compared to $110.0 million for the same period in 2025. Product revenue, net was $105.8 million in the second quarter of 2026, compared to $109.1 million for the same period in 2025. Net product revenue increased 11% versus the prior quarter, driven by stabilization of ZEJULA and continued volume growth for VYVGART. In the second half of the year, we expect to further stabilize product sales while laying the foundation for a return to meaningful growth in 2027. Research and Development (R&D) expenses were $61.8 million in the second quarter of 2026, compared to $50.6 million for the same period in 2025. This increase was primarily due to an increase in licensing fees under our license and collaboration agreements, partially offset by decreased clinical and pre-clinical costs. Selling, General and Administrative (SG&A) expenses were $72.9 million in the second quarter of 2026, compared to $71.0 million for the same period in 2025. SG&A remained relatively flat year over year, reflecting continued efforts to streamline the organization, optimize resource allocation, and enhance operating efficiency as the company advances its next phase of growth. Loss from operations was $76.5 million in the second quarter of 2026, $60.4 million when adjusted to exclude certain non-cash expenses including depreciation, amortization, and share-based compensation. A reconciliation of loss from operations (GAAP) to adjusted loss from operations (non-GAAP) is included at the end of this release. Net loss was $50.8 million in the second quarter of 2026, or a loss per ordinary share attributable to shareholders of $0.05 (or loss per American Depositary Share (ADS) of $0.46), compared to a net loss of $40.7 million for the same period in 2025, or a loss per ordinary share of $0.04 (or loss per ADS of $0.37). The increase in net loss was primarily due to higher licensing fees. Cash and cash equivalents, short-term investments, and current restricted cash totaled $717.5 million as of June 30, 2026, compared to $761.3 million as of March 31, 2026. Recent Pipeline Highlights Below are key product candidate updates since our last earnings release: Oncology Pipeline Zocilurtatug Pelitecan (zoci, DLL3-Targeting ADC) (formerly ZL-1310): TIVDAK (Tisotumab Vedotin, Tissue Factor ADC): Immunology, Neuroscience, and Infectious Disease Pipeline ZL-1503 (IL-13/IL-31Rα): Completed enrollment in the single ascending dose (SAD) portion of the Phase 1/1b study of ZL-1503 in healthy volunteers, with initial PK, PD, safety and immunogenicity data expected in the second half of 2026. Enrollment is ongoing in the multiple ascending dose (MAD) portion of the study in patients with atopic dermatitis. VYVGART (FcRn): In May 2026, the FDA approved the supplemental Biologics License Application (sBLA) submitted by Zai Lab’s partner argenx for VYVGART® (efgartigimod alfa-fcab) and VYVGART Hytrulo® (efgartigimod alfa and hyaluronidase-qvfc), expanding the label to include all serotypes of adult patients living with generalized myasthenia gravis (gMG) — anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative. The approval is based on data from the Phase 3 ADAPT SERON study. Zai Lab participated in the ADAPT SERON study in Greater China. Zai Lab is preparing to seek inclusion of VYVGART Hytrulo in China’s National Reimbursement Drug List (NRDL) in 2027. KarXT (xanomeline and trospium chloride) (M1/M4-agonist): In June 2026, Zai Lab commercially launched KarXT in mainland China for the treatment of schizophrenia in adults. KarXT is the first schizophrenia therapy with a novel mechanism of action approved in over 70 years, offering a fundamentally new approach to treating schizophrenia through selective activation of M1 and M4 muscarinic receptors. Zai Lab is preparing to seek inclusion of KarXT in China’s NRDL in 2027. Povetacicept (pove, APRIL/BAFF): In June 2026, Zai Lab partner Vertex announced that the FDA accepted its BLA submission for pove for accelerated approval in adults with immunoglobulin A nephropathy (IgAN), with a PDUFA target action date of November 30, 2026. Zai Lab participated in the global Phase 3 RAINIER study in Greater China. Anticipated Major Milestones in 2026 and the First Half of 2027 Global Pipeline Expected Clinical Developments and Data Readouts Zocilurtatug Pelitecan (zoci, DLL3-Targeting ADC; formerly ZL-1310) First-Line Extensive-Stage Small Cell Lung Cancer (ES-SCLC): Report initial Phase 1 data evaluating zoci in combination with atezolizumab, with or without chemotherapy, at the European Society for Medical Oncology (ESMO) 2026 Congress in October 2026 and, subject to emerging data and regulatory discussions, initiate a registrational Phase 3 study in the second half of 2026. Second-Line Plus ES-SCLC: Complete enrollment in the global pivotal Phase 3 DLLEVATE study in the first half of 2027 followed by a planned interim analysis with the potential to support a BLA submission for accelerated approval. epNECs: Complete enrollment in the Phase 2 expansion portion of the ongoing global Phase 1b/2 study evaluating zoci in patients with selected solid tumors and, subject to regulatory feedback, advance the program into registrational development in the second half of 2026. ZL-1503 (IL-13/IL-31Rα) Report initial first-in-human data from the SAD portion of the global Phase 1/1b study in healthy volunteers, including pharmacokinetics (PK), half-life, pharmacodynamic biomarkers (including pSTAT6), and safety, in the second half of 2026. Continue enrollment in the MAD portion of the Phase 1/1b study in patients with atopic dermatitis. Initial clinical data from the MAD portion expected in the first half of 2027. ZL-6201 (LRRC15 ADC) Provide topline results from the dose-escalation portion of the global Phase 1a/b study evaluating ZL-6201 in patients with sarcoma and selected tumors in the first half of 2027. ZL-1222 (PD-1/IL-12) Submit an IND application in the U.S. and initiate a global Phase 1 study in 2027. ZL-1311 (MUC17/CD3) Submit an IND application in the U.S. by year-end 2026 and initiate a global Phase 1 study in the first half of 2027. Regional Pipeline Upcoming Potential NMPA Acceptance Tumor Treating Fields (TTFields) in locally advanced pancreatic cancer. Expected Clinical Developments and Data Readouts Efgartigimod (FcRn) Myositis: Zai Lab partner argenx to provide topline results from the global Phase 2/3 ALKIVIA study evaluating autoimmune inflammatory myopathies (AIM or myositis) in the third quarter of 2026. Zai Lab participated in the ALKIVIA study in Greater China. Elegrobart (Anti-IGF-1R, subcutaneous) Zai Lab to complete enrollment in the Phase 3 registrational study for the treatment of thyroid eye disease in China in the third quarter of 2026. Zai Lab to provide topline results from the China Phase 3 registrational study in 2027. Conference Call and Webcast Information Zai Lab will host a live conference call and webcast today, August 6, 2026, at 8:00 a.m. ET (8:00 p.m. HKT). Listeners may access the live webcast by visiting the Company’s website at http://ir.zailaboratory.com. Participants must register in advance of the conference call. Details are as follows: Registration link for webcast (preferred): https://edge.media-server.com/mmc/p/4mhmttj2 Registration link for dial-in: https://register-conf.media-server.com/register/BIc69829b23daf4513a56e2253eaff583c All participants must use the link provided above to complete the online registration process in advance of the conference call. Dial-in details will be in the confirmation email which the participant will receive upon registering. A replay will be available shortly after the call and can be accessed by visiting the Company’s website. About Zai Lab Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health. For additional information about Zai Lab, please visit www.zailaboratory.com or follow us at https://x.com/ZaiLab_Global. Non-GAAP Measures In addition to results presented in accordance with GAAP, we disclose growth rates that have been adjusted to exclude the impact of changes due to the translation of foreign currencies into U.S. dollars. We have also presented a measure of adjusted loss from operations that adjusts GAAP loss from operations to exclude the impact of certain non-cash expenses including depreciation, amortization, and share-based compensation, which we refer to as "profitability." These adjusted growth rates and adjusted loss from operations are non-GAAP measures. We believe that these non-GAAP measures are important for an understanding of the performance of our business operations and financial results and provide investors with an additional perspective on operational trends and greater transparency into our historical and projected operating performance. Although we believe the non-GAAP financial measures enhance investors’ understanding of our business and performance, these non-GAAP financial measures should not be considered an exclusive alternative to accompanying GAAP financial measures. Zai Lab Forward-Looking Statements This press release contains certain forward-looking statements, including statements relating to our strategy and plans; potential of and expectations for our business, commercial products, and pipeline programs; our goals, objectives, and priorities and our expectations under our growth strategy (including our expectations regarding our commercial products and launches, clinical stage products, revenue growth, profitability, and cash flow); clinical development programs and related clinical trials; clinical trial data, data readouts, and presentations; risks and uncertainties associated with drug development and commercialization; regulatory discussions, submissions, filings, and approvals and the timing thereof; the potential benefits, safety, and efficacy of our products and product candidates and those of our collaboration partners; the anticipated benefits and potential of investments, collaborations, and business development activities; our profitability and timeline to profitability; our future financial and operating results; and financial guidance, including with respect to our capital allocation and investment strategy and our expected path to profitability. All statements, other than statements of historical fact, included in this press release are forward-looking statements, and can be identified by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "plan," "poised," "positioned," "possible," "potential," "will," "would," and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. We may not actually achieve the plans, carry out the intentions, or meet the expectations or projections disclosed in our forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products; (2) our ability to obtain funding for our operations and business initiatives; (3) the results of our clinical and pre-clinical development of our product candidates; (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates; (5) risks related to doing business in China; and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission (SEC). We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Our SEC filings can be found on our website at www.zailaboratory.com and on the SEC’s website at www.SEC.gov. View source version on businesswire.com: https://www.businesswire.com/news/home/20260806560438/en/ Contacts Investor Relations: Christine Chiou / Cyan Liu+1 (917) 886-6929 / +86 195 3130 [email protected] / [email protected] Media: Shaun Maccoun / Xiaoyu Chen+1 (415) 317-7255 / +86 185 0015 [email protected] / [email protected]

Image source: The Motley Fool. Thursday, May 7, 2026 at 9 a.m. ET Chairperson and CEO — Ying Du President, Head of Global R&D and CMO — Rafael Amado Chief Operating Officer — Joshua Smiley Chief Financial Officer — Yajing Chen Ying Du: Thank you, Christine. Good morning, and good evening, everyone. Thank you for joining us today. Zai Lab is at a pivotal moment. Since our founding, we have built a fully integrated R&D engine capable of taking assets from discovery through global registrational studies, with the ability to design and execute multiple central trials globally. The impact of this investment is beginning to emerge. Our pipeline is expanding, our global assets are generating meaningful data, and our lead asset is in the global pivotal stage. We are also leveraging AI and data-driven approaches across the organization to enhance speed, precision and efficiency, strengthening overall execution and corporate productivity, which we expect will drive further results. Last month at AACR, we presented new data for Zoci that reinforced our conviction, including strong efficacy both systemically and in the brain in patients with small cell lung cancer, alongside a best-in-class safety profile. We also announced global collaborations with Amgen and Boehringer Ingelheim to explore Zoci as a potential backbone therapy in small cell lung cancer and neuroendocrine carcinomas, 2 cancer types with significant unmet medical need. In late 2027, we expect to submit our first global BLA to the FDA, a defining milestone that marks our successful transformation to a global biotech company. Beyond Zoci, we're building a growing portfolio of global clinical programs, including ZL-1503 for atopic dermatitis, now in a Phase I/Ib study. This reflects the strength of our R&D engine, which combines rigorous science with operational speed and efficiency to advance differentiated assets into global development. Our reasonable business remains commercially profitable with a strong balance sheet. We are focused on strengthening our commercial capabilities and execution, and I'm pleased to welcome Dr. Yizhe Wang as an operating partner to work with me to drive commercial performance and readiness ahead of upcoming launches. The recent policy developments in the region, including the State Council directive, signal meaningful government support for innovative medicines, and we believe Zai Lab is well positioned to benefit over the medium to long term, given our first- and best-in-class portfolio. We're confident in Zai's future, which will be defined by our growing global and regional pipeline of differentiated assets. With that, I'll now turn the call over to Rafael. Rafael Amado: Thank you, Samantha. Over the past years, we have built a globally integrated R&D engine that spans from discovery through global registrational development while also delivering on regional development across therapy areas. Our ability to design and execute high-quality global studies with speed and discipline is a core strength that positions us well for development across regulatory geographies. We are embedding AI in R&D, including drug discovery and clinical trial design, to enhance the quality of our decisions and to more efficiently advance our pipeline. The data we presented at AACR last month highlights the output of this engine across our global pipeline that included both externally sourced and internally discovered products. Let me start with Zoci. In extensive-stage small cell lung cancer, at the go-forward dose of 1.6 milligrams per kilogram, Zoci demonstrated a confirmed intracranial overall response rate of 62.5% and a best overall intracranial response rate approaching 69%, including 4 complete responses. Grade 3 or higher treatment-related adverse events were approximately 16%. Responses of this magnitude inside the brain in one of the most treatment-resistant tumor types in oncology are meaningful signals of differentiation. The safety data reinforced what we have consistently observed. This is a best-in-class profile. Our registrational Phase III DLLEVATE study is enrolling well and is on track to complete enrollment in the first half of 2027, positioning us for an interim analysis and potential accelerated approval submission next year. In extrapulmonary neuroendocrine carcinoma, a setting where there is no established standard of care in the second line and beyond, Zoci demonstrated a confirmed ORR of 38.2%. This compares favorably to currently used regimens, which typically show response rates of approximately 18% with limited durability. We are actively engaging with regulators on a potential registrational path and are well underway recruiting into an extension single-arm study. Depending on the outcomes of regulatory discussions, we could initiate a registrational or confirmatory study by year-end. Now on the collaborations with Amgen and Boehringer Ingelheim exploring Zoci in combination with T-cell engagers. The scientific rationale is straightforward. Zoci delivers rapid tumor debulking through targeted cytotoxicity, while T-cell engagers drive antigen-dependent immune-mediated killing. The mechanisms are complementary, the toxicity profiles are expected to have limited overlap, and together, they have the potential to deepen and extend responses in ways neither mechanistic approach achieves alone. The Phase I with Amgen, which includes a cohort of untreated patients with triple combination of Zoci, IMDELLTRA and Imfinzi is already enrolling and the BI study is expected to follow in the coming months. We're also evaluating Zoci in combination with PD-L1 with or without chemotherapy in a Phase I study in first-line small cell lung cancer with data expected later this year. The chemo-sparing approach may allow for extended treatment duration compared to chemotherapy alone, where patients typically discontinue after 4 cycles. This is the basis of our Phase III strategy with IO, which we are actively discussing with regulators. Beyond Zoci, our global oncology pipeline continues to advance. ZL-6201, our LRRC15 ADC is already in the clinic. ZL-1311, our wholly owned MUC17 targeting T-cell engager is expected to enter the clinic by year-end. We will provide updates as data mature. On the regional oncology side, we submitted a marketing authorization application for Tumor Treating Fields in locally advanced pancreatic cancer and expect an approval for this indication by year-end and for Tivdak for cervical cancer in the coming months. Turning to immunology. We recently presented preclinical data for ZL-1503, our IL-13/IL-31 receptor alpha bispecific at Immunology 2026. The data showed rapid and durable inhibition of both IL-13-driven inflammation and IL-31-mediated pruritus across disease models in nonhuman primates with sustained effect following single dose. We believe this data supports the potential for differentiated efficacy, less frequent dosing and broad application across multiple atopic diseases, including asthma, rhinitis and conjunctivitis. Initial Phase I data in healthy volunteers and atopic dermatitis patients are expected in the second half of this year. Finally, in our regional immunology portfolio, our partner, Vertex, reported positive Phase III interim results from the RAINIER study of povetacicept in IgA nephropathy achieving approximately a 50% reduction in proteinuria versus placebo and meeting both the primary and all secondary endpoints. I want to close with a broader point. The progress I've described today reflects a pipeline strategy built on biological rationale, clinical differentiation and execution and an organization that now has the infrastructure to advance multiple program simultaneously at speed and across geographies. We have significant data emerging throughout the year, and I look forward to providing those updates. And with that, I'll hand it over to Josh. Joshua Smiley: Thank you, Rafael, and hello, everyone. Let me start with our first quarter performance, which reflected Chinese New Year seasonality as well as near-term product-specific dynamics. Starting with ZEJULA. Performance in the quarter was impacted by a shift in hospital utilization patterns following volume-based procurement for generic olaparib and some incremental competitive pressure in the PARP inhibitor class. Our first-line positioning remains intact, supported by our label advantage, and we are working hard on stabilizing and driving demand. On VYVGART, physician confidence remains strong and our share within biologics is stable. We delivered double-digit volume growth year-on-year in the quarter, offset by a 12% price discount related to NRDL renewal. On a full year basis, we expect a similar level of volume growth as we continue to shape gMG treatment dynamics. The long-term opportunity stays significant. Biologic penetration in the gMG maintenance setting remains around 15%, suggesting a runway for growth, plus upcoming Phase III readouts in new indications such as IIM and Sjogren's add potential upside. For XACDURO, patient demand was strong and hospital adoption continued to expand. Performance was constrained by supply, and we expect those constraints may persist through the remainder of the year. That said, the underlying demand is encouraging and local manufacturing expected in 2027 should alleviate supply pressure and support meaningful growth and margin expansion over time. Looking ahead, we see a strong set of commercial catalysts. KarXT launches in the second quarter and represents the first novel mechanism for schizophrenia in decades, a significant moment for the approximately 8 million patients living with this disease in China. KarXT's inclusion in national treatment guidelines ahead of launch reflects strong clinical confidence in this therapy. Our focus this year is on physician education and market development, building a strong foundation for the brand. We also anticipate potential regulatory approval for Tivdak this year and intend to leverage our existing ZEJULA infrastructure to drive commercial synergies and accelerate uptake. More broadly, our late-stage pipeline provides multiple additional growth opportunities in the region. Recent positive Phase III readouts for povetacicept in IgAN and Elegrobart in thyroid eye disease add further depth to our long-term growth profile, and we see both as meaningful future contributors. Lastly, we are applying AI to sharpen commercial execution from physician targeting and field force optimization to real-time competitive insights, enabling more agile and informed go-to-market decisions. 2026 is about execution, delivering on key launches, stabilizing the portfolio and building momentum. And with that, I will now pass the call over to Yajing to take us through our financial results. Yajing? Yajing Chen: Thank you, Josh. Our quarter 1 results reflect the near-term dynamics just described. First quarter total product revenue declined 6% year-over-year to $99.6 million, driven by lower ZEJULA sales, partially offset by continued growth from XACDURO and NUZYRA. While we expect total product revenue to improve sequentially over the next 9 months as underlying demand continues to build, we anticipate near-term pressure for 2026 full year total product revenues with a return to growth in 2027. Turning now to our expenses. Our commitment to financial discipline is reflected in continued execution against our R&D and commercial priorities, and we will expand AI utilization from process automation to agentic execution to further improve cost efficiencies. R&D expenses for the first quarter increased 8% year-over-year, driven by increased license fees and clinical trial-related expenses, partially offset by lower personnel compensation expenses due to resource prioritization and efficiency efforts. SG&A expenses increased slightly year-over-year, mainly due to higher general selling expenses. As a result, loss from operations increased by 23% for the quarter to $69.4 million. We ended the quarter with a cash position of $761.3 million. Our regional business is commercially profitable. Our global pipeline continues to progress steadily. Our focus this year remains on the strengthening the regional business, executing across global pipeline and deploying capital thoughtfully to support both near-term launches and long-term growth drivers. With a strong balance sheet, we are well positioned to execute against these priorities. Operator, please open up the line for questions. Operator: [Operator Instructions] The question comes from the line of Jonathan Chang from Leerink Partners. Jonathan Chang: First question, on the Zoci collaborations evaluating the combinations with DLL3 T cell engagers. How do these facilitate your longer-term strategy? And are there other combinations and collaborations that make sense to explore? And then second question on the commercial business in China, can you give us a sense for how to think about revenues over the course of the year? Joshua Smiley: Jonathan, it's Josh. Thank you. I'll ask Rafael to take the first one, and then Yajing can take the second. Rafael Amado: Yes. Thanks for the questions. This combination, I spoke about the rationale of it during the prepared remarks. And the expectation is that we would get better efficacy in terms of responses, durability and eventually better survival than with each agent alone. We're testing it in second line in tarlatamab-naive patients, tarlatamab experienced patients, but importantly, also in first line. Our first-line study will not include tarlatamab as the pivotal trial to begin with until we get more data. But if the data are positive, we may consider progressing this and developing it as a best-in-class regimen. So, it's really improving the baseline treatment of this disease with 2 really very active mechanisms. Joshua Smiley: Thanks, Rafael. Yajing? Yajing Chen: Yes. Jonathan, as I mentioned before, our revenue in the next 9 months, you're going to expect to see some sequential growth. But for the full year revenue, we are going to continue to experience some short-term pressure. So we are seeing the return to growth in 2027. Operator: And the next question comes from the line of Michael Yee from UBS. Kaiyue Yang: This is Kyle Yang for Michael Yee from UBS. Two for us. So the first question is, for your upcoming data readout for IL-13 and IL-31, what is the expectation for data? And how do you expect the data set in healthy volunteers to derisk the asset? And when do we expect data from moderate to severe atopic dermatitis patients? The second question is that for your data set in frontline small cell lung cancer in the second half, what is the expectation for that? And also what's the data? How do you pick the go-forward regimen in terms of doublet versus triplet? Joshua Smiley: Thanks, Kyle. Go ahead, Rafael. Rafael Amado: Yes. So with the first question in terms of expectations for ZL-1503, the healthy volunteers data, I think, is going to be very useful. We actually have progressed the study quickly with those cohorts. And we would be looking at safety, obviously, pharmacokinetics to evaluate dosing interval, which we expect to be prolonged dosing. Pharmacodynamics such as phospho-STAT and others and antidrug antibody. So, all of this, I think, will inform the basic parameters that will allow us to continue the development of the product. And with regards to what to expect, obviously, it depends on how much data we have on atopic dermatitis, but we should have data on healthy volunteers by the end of the year and at least some of the cohorts with atopic dermatitis. So, our expectation is that we may publish this data before the end of the year. And then with regards to first line we -- the question was what do we consider as go forward. Well, you know that the chemotherapy plus checkpoint inhibitor, which would be the control of our study has a PFS of about 5 months or so. Our response rate in second line with 1.6 milligrams per kilogram is in the order of 68%. So obviously, there's still room for improvement there. So, we will be looking for higher response rates and also longer PFS than that, that we believe is clinically significant. And we plan to present this data towards the fall or so. And by then, we should have sufficient follow-up to really be able to evaluate that. But we're currently planning to proceed with this study before the end of the year and in discussions with regulators. Operator: Now we're going to take our next question, and it comes from the line of Anupam Rama from JPMorgan. Anupam Rama: Just with the recent positive data for povetacicept in IgAN, what are the plans to submit in regional China? And just remind us, is there going to be any bridging work required? Joshua Smiley: Thanks, Anupam. Okay, Rafael. Rafael Amado: Yes. We were very pleased to see the results of the RAINIER study. They're really a good advance for IgAN. The filing of our partner has taken place, and we will discuss with CDE what the regulatory requirements for filing, but we expect that we would be able to proceed because we did include patients from China in the study and the bridging study is not expected to be required. So as our partner, we would discuss with CDE our approach to an accelerated approval with this product. Operator: Now we're going to take our next question. And the question comes from the line of Li Watsek from Cantor. Unknown Analyst: This is Vin on for Li. So a question about ZL-1503, the bispecific antibody. So it seems like data is going to come in the second half of this year. But there's a lot of bispecific antibody out there in AD. So I would like to know what's your base assumption on the market differentiation for this drug and -- also your -- strategy there. Are you planning to run a Phase II trial or are you potentially going to [form a result]? Joshua Smiley: Rafael, why don't you address that, and I can make a couple of commercial comments. Rafael Amado: Sure. Yes, in terms of differentiation, as I mentioned, I think long-term dosing is important, and we still have to evaluate how often that would be, but we expect that, that would be the case for ZL-1503. And in terms of activity, the key activity is obviously decreasing pruritus because our product inhibits the IL-31 receptor. And so we expect using the rating scale that we would have a meaningful decrease in pruritus that's also occurring early on in the treatment because I think that's really important and differentiating from other products. The same for skin pain, which is something that affects the quality of life of patients. And of course, the main endpoint, which tends to be EASI-75, which you know what the benchmark out there is in the 40% range. So surpassing these numbers would be together with the extended dosing is something that we would consider very positive for us to move forward with Phase II. And as of the question of whether or not we plan to do that, the answer is yes. We plan to do our Phase II study and evaluate these parameters, as I mentioned before. Joshua Smiley: Yes. And I think just to comment, it's Josh. Obviously, it's a competitive class, but there's lots of room for differentiation, still very undertreated. So I think as Rafael said, what we know about patients is dosing convenience makes a difference, relief on itch and speed of onset are all important things, things that will elucidate over the course of the clinical development program. So we're quite excited about the opportunity here. Operator: [Operator Instructions] And now we're going to take our next question. And the question comes to line of Ziyi Chen from Goldman Sachs. Ziyi Chen: I got 2 questions. The first one is on Zoci. We noticed that Amgen has initiated Phase I study for tarlatamab plus Zoci with and without PD-L1 in small cell lung cancer. So could you share a bit more about your thoughts on potential dose levels you're going to explore, particularly considering for tarlatamab, FDA has -- actually has a black box in their label. And what are the potential dose levels you're going to be exploring for Zoci and also for tarlatamab? And also, have you considered to test a sequential use of those 2 drugs? Or instead, you're going to be more focusing on administrating those 2 drugs together to patients? And my second question is regarding efgartigimod in China. Could you please comment on the evolving landscape given that now RemeGen's Telitacicept has been also enrolled into NRDL, particularly in the first quarter. Have you seen any of the change to the market dynamics? Joshua Smiley: Rafael, do you want to start on Zoci and then I'll comment on VYVGART? Rafael Amado: Sure. Thanks for the question. Yes, the study is actually enrolling now. In terms of the dose levels, we wanted to have a Q3 weekly regimen with both drugs. And the dose of tarlatamab will be fixed. And we will do hopefully a rapid dose escalation with Zoci up to 1.6 mg per kg, which is the go-to dosing that we have for DLLEVATE, our Phase III study in second line. So as I mentioned before, this will be in various clinical settings, including the triplet combination with checkpoint inhibitors, as you mentioned, in frontline and treated patients. So in terms of whether it's sequential versus together -- given the mechanism of action, we want the rapid debulking to be present when the T cell engager is given. So they're given in fast sequence. We're not going to test alternating sequences or other schedules. So I hope that helps. Joshua Smiley: Thanks, Rafael. And on VYVGART, first, as we mentioned, we're seeing double-digit volume increases in Q1. That's a function of both of new patients continuing to come in and get started and extending duration of therapy. That being said, there's still only about 15% of patients that would qualify for a biologic therapy in gMG are getting it. So I think having additional competition is fine. We don't really see an impact from Teli to any measurable degree in Q1. And again, we would expect as we get through the year that continuing to emphasize getting patients with gMG on to biologic therapy and getting them the benefits of longer-term maintenance is going to help everybody. So -- that's what we're focused on. Operator: [Operator Instructions] There are no further questions for today. I would now like to hand the conference over to your speaker, Samantha Du, for any closing remarks. Samantha? Please go ahead. Ying Du: Thank you, operator. I want to thank everyone for taking the time to join us on the call today. We appreciate your support and look forward to updating you again after the second quarter of 2026. Operator, you may now disconnect this call. Thank you. Operator: This concludes today's conference call. Thank you for participating. You may now all disconnect. Have a nice day. 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Interested in Zai Lab Limited Unsponsored ADR? Here are five stocks we like better. Q1 product revenue fell 6% year over year to $99.6 million, as ZEJULA weakness and other portfolio dynamics pressured results. Zai Lab also posted a wider operating loss of $69.4 million and said it expects near-term revenue pressure in 2026 before returning to growth in 2027. Management highlighted a series of pipeline and regulatory milestones, led by oncology asset zoci, which showed encouraging intracranial response data in small cell lung cancer and could support accelerated approval timing. The company is also advancing immunology candidate ZL-1503 and noted positive partner data for povetacicept. The commercial portfolio was mixed: VYVGART saw double-digit volume growth, XACDURO faced supply constraints, and KarXT is set to launch in China for schizophrenia in Q2. Zai Lab ended the quarter with $761.3 million in cash and said it remains focused on execution and capital discipline. Zai Lab Stock Has Fallen to Value Levels Zai Lab (NASDAQ:ZLAB) reported a year-over-year decline in first-quarter 2026 product revenue as pressure on ZEJULA weighed on results, while management emphasized progress across its global oncology and immunology pipeline and pointed to multiple upcoming regulatory and clinical milestones. On the company’s earnings call, Founder, Chairperson and CEO Samantha Du said Zai Lab is at “a pivotal moment,” citing the company’s investment in a fully integrated research and development platform and its move toward global registrational studies. Du said the company expects to submit its first global biologics license application to the U.S. Food and Drug Administration in late 2027, tied to its lead asset zoci. → Insider Sales: Top AST SpaceMobile Insider Cuts Postion Over 30% “Our pipeline is expanding, our global assets are generating meaningful data, and our lead asset is in global pivotal stage,” Du said. She added that Zai Lab is using artificial intelligence and data-driven approaches across the organization to improve speed, precision and efficiency. Chief Financial Officer Yajing Chen said total product revenue in the first quarter declined 6% year over year to $99.6 million. She said the decline was driven by lower ZEJULA sales, partially offset by continued growth from ZEJULA and NUZYRA, as stated on the call. → Light Speed Returns: Corning Cashes In on NVIDIA Growth Chen said Zai Lab expects total product revenue to improve sequentially over the next nine months as demand builds, but the company anticipates “near-term pressure” for full-year 2026 product revenue and a return to growth in 2027. Research and development expenses rose 8% year over year in the quarter, driven by increased license fees and clinical trial-related expenses, partially offset by lower personnel compensation expenses tied to resource prioritization and efficiency efforts. Selling, general and administrative expenses increased slightly, mainly due to higher general selling expenses. Loss from operations increased 23% to $69.4 million. → Years in the Making, AMD’s Upside Movement Has Just Begun Zai Lab ended the quarter with $761.3 million in cash. Chen said the company’s regional business is commercially profitable and that management remains focused on strengthening the regional business, advancing the global pipeline and deploying capital thoughtfully. President and Chief Operating Officer Josh Smiley said first-quarter performance reflected Chinese New Year seasonality and product-specific dynamics. For ZEJULA, Smiley said results were hurt by changes in hospital utilization patterns following volume-based procurement for generic olaparib, along with incremental competitive pressure in the PARP inhibitor class. He said ZEJULA’s first-line positioning remains intact, supported by its label advantage, and that the company is working to stabilize and drive demand. For VYVGART, Smiley said physician confidence remains strong and the product’s share within biologics is stable. He said Zai Lab delivered double-digit year-over-year volume growth in the quarter, offset by a 12% price discount related to National Reimbursement Drug List renewal. He said biologic penetration in the generalized myasthenia gravis maintenance setting remains around 15%, suggesting additional room for growth. XACDURO saw strong patient demand and expanding hospital adoption, but performance was constrained by supply, Smiley said. He added that supply constraints may persist through the remainder of the year, while local manufacturing expected in 2027 should help ease pressure and support growth and margin expansion over time. Smiley also highlighted KarXT, which is expected to launch in the second quarter for schizophrenia in China. He called it the first novel mechanism for schizophrenia in decades and said its inclusion in national treatment guidelines ahead of launch reflects clinical confidence. The company is also anticipating potential regulatory approval for TIVDAK this year and plans to leverage its ZEJULA infrastructure to support uptake. President and Head of Global Research and Development Rafael Amado focused much of his update on zoci, the company’s lead oncology program. In extensive-stage small cell lung cancer, Amado said zoci demonstrated a confirmed intracranial overall response rate of 62.5% at the go-forward dose of 1.6 mg/kg, with a best overall intracranial response rate approaching 69%, including four complete responses. Grade 3 or higher treatment-related adverse events were approximately 16%. Amado described the intracranial activity as a meaningful signal of differentiation in a treatment-resistant cancer type and said the safety profile reinforces the company’s view that zoci has best-in-class potential. The registrational Phase 3 DLLEVATE study is enrolling and remains on track to complete enrollment in the first half of 2027, positioning the company for an interim analysis and potential accelerated approval submission next year. In extrapulmonary neuroendocrine carcinoma, Amado said zoci demonstrated a confirmed overall response rate of 38.2%, comparing favorably with commonly used regimens that typically show response rates of about 18% with limited durability. He said Zai Lab is engaging regulators on a potential registrational path and could initiate a registrational or confirmatory study by year-end, depending on those discussions. Zai Lab also discussed collaborations with Amgen and Boehringer Ingelheim to evaluate zoci in combination with T-cell engagers. Amado said the rationale is that zoci provides rapid tumor debulking through targeted cytotoxicity, while T-cell engagers drive antigen-dependent immune-mediated killing. He said a Phase 1 study with Amgen, including a cohort of untreated patients receiving zoci, IMDELLTRA and Imfinzi, is already enrolling, while the Boehringer Ingelheim study is expected to follow in the coming months. In immunology, Zai Lab highlighted ZL-1503, its IL-13/IL-31Rα bispecific antibody. Amado said recent preclinical data showed rapid and durable inhibition of IL-13-driven inflammation and IL-31-mediated pruritus across disease models in non-human primates, with sustained effects after a single dose. Amado said initial Phase 1 data in healthy volunteers and atopic dermatitis patients are expected in the second half of the year. During the question-and-answer session, he said healthy volunteer data should help assess safety, pharmacokinetics, dosing interval, pharmacodynamics and anti-drug antibodies. He said Zai Lab expects to have healthy volunteer data by year-end and at least some data from atopic dermatitis cohorts, with a possible publication before year-end. Amado said potential differentiation for ZL-1503 could include less frequent dosing, early and meaningful reduction in pruritus, improvement in skin pain and competitive EASI-75 results. He said the company plans to conduct a Phase 2 study. The company also cited positive Phase 3 interim results reported by partner Vertex for povetacicept in IgA nephropathy. Amado said the RAINIER study showed approximately a 50% reduction in proteinuria versus placebo and met its primary and secondary endpoints. In response to an analyst question, he said Zai Lab expects to discuss regulatory requirements with China’s Center for Drug Evaluation and does not expect a bridging study to be required because Chinese patients were included in the study. While management acknowledged near-term revenue pressure in 2026, executives framed the year as one focused on execution, including commercial stabilization, new launches and pipeline advancement. Smiley said Zai Lab is applying artificial intelligence to commercial execution, including physician targeting, field force optimization and competitive insights. Du said recent policy developments in the region, including a State Council directive supporting innovative medicines, could benefit the company over the medium to long term. “2026 is about execution,” Smiley said, citing key launches, portfolio stabilization and momentum building as priorities. Zai Lab Ltd (NASDAQ: ZLAB) is a biopharmaceutical company focused on the research, development, manufacturing and commercialization of innovative therapies. Headquartered in Shanghai, China, Zai Lab operates R&D centers in Asia and the United States and maintains commercial offices across Greater China, North America, Europe and Australia. The company's end-to-end platform encompasses discovery biology, translational development, clinical research and global supply chain management. The company's marketed portfolio is anchored by Brukinsa (zanubrutinib), a next-generation Bruton's tyrosine kinase inhibitor approved for several B-cell malignancies. The article "Zai Lab Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.

For the quarter ended March 2026, Zai Lab Limited Unsponsored ADR (ZLAB) reported revenue of $99.61 million, down 6.5% over the same period last year. EPS came in at -$0.46, compared to -$0.45 in the year-ago quarter. The reported revenue represents a surprise of -8.21% over the Zacks Consensus Estimate of $108.52 million. With the consensus EPS estimate being -$0.58, the EPS surprise was +20.69%. While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how they compare to Wall Street expectations to determine their next course of action, some key metrics always provide a better insight into a company's underlying performance. As these metrics influence top- and bottom-line performance, comparing them to the year-ago numbers and what analysts estimated helps investors project a stock's price performance more accurately. Here is how Zai Lab Limited performed in the just reported quarter in terms of the metrics most widely monitored and projected by Wall Street analysts: Product Revenue, net: $95.56 million compared to the $107.93 million average estimate based on three analysts. Product Revenue- NUZYRA: $16.3 million versus the two-analyst average estimate of $16.46 million. The reported number represents a year-over-year change of +7.8%. Collaboration revenue: $4.06 million versus the two-analyst average estimate of $0.87 million. Product Revenue- XACDURO: $8.6 million versus the two-analyst average estimate of $7.84 million. Product Revenue- ZEJULA: $30 million versus the two-analyst average estimate of $41.33 million. The reported number represents a year-over-year change of -39.4%. Product Revenue- VYVGART: $17.6 million compared to the $20.95 million average estimate based on two analysts. The reported number represents a change of -2.8% year over year. View all Key Company Metrics for Zai Lab Limited here>>> Shares of Zai Lab Limited have returned -1.8% over the past month versus the Zacks S&P 500 composite's +11.4% change. The stock currently has a Zacks Rank #4 (Sell), indicating that it could underperform the broader market in the near term. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Zai Lab Limited Unsponsored ADR (ZLAB) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research