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    Zai Lab Announces Third Quarter 2023 Financial Results and Recent Corporate Updates

    11/7/23 4:05:00 PM ET
    $ZLAB
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $ZLAB alert in real time by email
    • Total product revenue of $69.2 million for the third quarter of 2023, representing 22% y-o-y growth; 27% y-o-y growth at constant exchange rate (CER)



    • VYVGART® (efgartigimod alfa injection) achieved $4.9 million sales since its commercial launch in September in China



    • Strong balance sheet with a cash position of $822.2 million as of September 30, 2023, compared to $876.4 million as of June 30, 2023



    • Company to host conference call and webcast on November 8, 2023, at 8:00 a.m. ET

    SHANGHAI, China and CAMBRIDGE, Mass., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))) today announced financial results for the third quarter of 2023, along with recent product highlights and corporate updates.

    "During the third quarter, we achieved important milestones, including the successful launch of VYVGART in China for patients with generalized myasthenia gravis (gMG) and the positive pivotal trial readout for efgartigimod in chronic inflammatory demyelinating polyneuropathy (CIDP)," said Dr. Samantha Du, Founder, Chairperson, and Chief Executive Officer of Zai Lab. "These developments underscore our unwavering commitment to delivering innovative medicines to patients in need. With new drug applications under review by the National Medical Products Administration (NMPA) and multiple ongoing pivotal trials evaluating drugs with significant market potential, we are well-positioned to accelerate our pipeline and to expand our portfolio of commercial assets as we work to elevate patient care worldwide."

    "Our commercial team navigated macro-level challenges in the third quarter to achieve y-o-y net product revenue growth of 27% on a constant currency basis," said Josh Smiley, President and Chief Operating Officer of Zai Lab. "ZEJULA® continues to be the leading PARP inhibitor in hospital sales for ovarian cancer in China, and there is exciting momentum with the launch of VYVGART, a potentially paradigm changing therapy for patients living with gMG in China. At least seven additional product launches in the next two to three years are expected to support meaningful revenue growth, and this growth, combined with enhanced operational efficiencies, will help lead us to profitability," Mr. Smiley concluded.

    Third Quarter 2023 Financial Results

    • Product revenues were $69.2 million for the third quarter of 2023, compared to $57.0 million for the same period in 2022, representing 22% y-o-y growth and 27% y-o-y growth at CER. This increase was primarily driven by increased sales volumes, the launch of VYVGART, and decreased negative effects from the COVID-19 pandemic. Our revenue growth was slowed by the effects on hospital and physician practices from the recent industry-wide anti-corruption enforcement efforts in China. Product revenues in the third quarter of 2023, compared to the same period in 2022, included:



      • $41.6 million for ZEJULA, which increased from $39.2 million, as ZEJULA, which is in its third year on the NRDL, continued to be the leading PARP inhibitor in hospital sales for ovarian cancer in China;
      • $11.6 million for Optune, which increased from $10.7 million, supported by increased patient access to this product in the private-pay market;
      • $5.7 million for QINLOCK, which increased from $5.5 million, supported by the NRDL listing in March 2023;
      • $5.5 million for NUZYRA, which increased from $1.5 million, supported by the NRDL listing in March 2023; and
      • $4.9 million for VYVGART, compared to nil, due to the launch of VYVGART in September 2023. 
    • Research and Development (R&D) expenses were $58.8 million for the third quarter of 2023, compared to $99.5 million for the same period in 2022. This decrease was primarily due to a decrease in licensing fees in connection with decreased upfront and milestone payments for our licensed and collaboration agreements.



    • Selling, General and Administrative expenses were $68.6 million for the third quarter of 2023, compared to $66.6 million for the same period in 2022. This increase was primarily due to higher general selling expenses to support new product launches, partially offset by a decrease in professional services fees.



    • Net loss was $69.2 million for the third quarter of 2023, or a loss per ordinary share attributable to common stockholders of $0.07, compared to a net loss of $161.2 million for the same period in 2022, or a loss per ordinary share of $0.17. The decrease in net loss was primarily due to increase of product revenue, the decrease of licensing fees, and the shift from foreign currency loss to gain.



    • Cash and cash equivalents, short-term investments and restricted cash totaled $822.2 million as of September 30, 2023, compared to $876.4 million as of June 30, 2023.

    Recent Product Highlights and Corporate Updates

    Below are key product and corporate updates since our last earnings release:

    Commercial Products

    • VYVGART (efgartigimod, FcRn): In September 2023, we launched VYVGART as an add-on to standard therapy for the treatment of adult patients with gMG who are anti-acetylcholine receptor (AChR) antibody positive in mainland China, increasing our number of commercial products to five. We are in the negotiation process for VYVGART's inclusion on the National Reimbursement Drug List (NRDL) to help support increased patient access for this therapy.



    • ZEJULA (niraparib, PARP): In September 2023, we conducted the final overall survival (OS) analysis for the Phase 3 NORA study in Chinese patients with platinum-sensitive recurrent ovarian cancer, which supports the NMPA's approval of ZEJULA for patients with recurrent ovarian cancer in China. The final OS results showed that niraparib maintenance treatment in the recurrent setting provides a favorable trend in OS irrespective of gBRCA mutation status compared with placebo. We expect to present detailed results at an upcoming medical conference.

    Oncology Pipeline

    • KRAZATI® (adagrasib, KRASG12C):



      • First-line non-small cell lung cancer (NSCLC): In October 2023, Zai Lab partner Mirati Therapeutics, Inc. (Mirati) announced updated results from the KRYSTAL-7 Phase 2 study evaluating adagrasib combined with pembrolizumab in first-line KRASG12C-mutated NSCLC at the European Society of Medical Oncology Congress (ESMO) 2023. The results demonstrate a manageable safety profile and early signs of durability of adagrasib in combination with a checkpoint inhibitor in the first-line NSCLC setting. We are participating in the study in mainland China, Hong Kong, Macau and Taiwan (collectively, Greater China).



      • Second-line+ NSCLC: In September 2023, Mirati presented two-year follow-up data from a pooled analysis of the Phase 1/1b Cohort and Phase 2 Cohort A for the KRYSTAL-1 study in previously treated patients with KRASG12C-mutated NSCLC at the 2023 World Conference on Lung Cancer (WCLC). In the pooled analysis, adagrasib demonstrated durable efficacy and a manageable long-term safety profile. We are participating in the ongoing confirmatory Phase 3 KRYSTAL-12 study in previously treated patients with KRASG12C-mutated NSCLC in Greater China.



    • Repotrectinib (ROS1/TRK):



      • NTRK-positive solid tumors: In August 2023, the Center for Drug Evaluation (CDE) of the NMPA granted Breakthrough Therapy Designation (BTD) for repotrectinib for the treatment of patients with advanced solid tumors that have an NTRK gene fusion who have progressed following treatment with TRK tyrosine kinase inhibitors (TKIs). This BTD was supported by data from both global and Chinese patients enrolled in the Phase 1/2 TRIDENT-1 study.



      • ROS1-positive NSCLC: In August 2023, Zai Lab partner Bristol Myers Squibb (BMS) announced updated results from the registrational TRIDENT-1 study, demonstrating that repotrectinib continued to demonstrate high response rates and durable responses, including robust intracranial responses, in patients with ROS1-positive locally advanced or metastatic NSCLC who were TKI-naïve or previously treated with one TKI and no chemotherapy. We are participating in the study in Greater China.



        • Based on results from the TRIDENT-1 trial, the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) submitted by BMS for repotrectinib in ROS1-positive NSCLC and granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) goal date of November 27, 2023.



        • The NDA we submitted to the NMPA for repotrectinib in ROS1-positive NSCLC has been accepted with priority review.



    • TIVDAK® (tisotumab vedotin): In October 2023, Zai Lab partner Seagen Inc. and Genmab A/S presented results from the Phase 3 innovaTV 301 randomized global trial at the ESMO 2023 Congress in recurrent or metastatic cervical cancer patients with disease progression on or after front-line therapy. TIVDAK demonstrated superior OS, progression-free survival (PFS) and objective response rate, compared to chemotherapy alone, and there were no new safety signals. We are participating in the global trial and extension study in Greater China.



    • Odronextamab (CD20xCD3): In September 2023, Zai Lab partner Regeneron announced that the FDA has accepted for Priority Review the Biologics License Application (BLA) for odronextamab to treat adult patients with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), who have progressed after at least two prior systemic therapies, with a PDUFA goal date of March 31, 2024. In August 2023, the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application for odronextamab for the same indications.



    • ZL-1211 (Claudin18.2): Based on a review of the competitive landscape and market opportunity, we decided to terminate ZL-1211 for internal development.



    • Tumor Treating Fields: In August 2023, Zai Lab partner NovoCure Limited announced that the Phase 3 INNOVATE-3 clinical trial of TTFields together with paclitaxel in patients with platinum-resistant ovarian cancer did not meet its primary endpoint of OS at the final analysis. We did not participate in this study.

    Autoimmune Disorders, Infectious Disease, and Neuroscience Pipeline

    • Efgartigimod (FcRn): In September 2023, the CDE of China's NMPA granted BTD for efgartigimod alfa injection (subcutaneous injection) (efgartigimod SC) in CIDP. This BTD was supported by positive data from both global and Chinese patients enrolled in the ADHERE study.



    • KarXT (xanomeline-trospium, M1/M4-agonist):



      • Schizophrenia: In September 2023, Zai Lab partner Karuna Therapeutics, Inc. (Karuna) announced that it had submitted an NDA to the FDA for the treatment of schizophrenia, supported by data from three positive registrational trials. We continue to enroll patients in the registrational bridging study in mainland China.



      • Alzheimer's disease psychosis (ADP): Karuna initiated the Phase 3 ADEPT-2 and ADEPT-3 trials in ADP in the third quarter. We plan to participate in these studies in Greater China next year.

    Corporate Update

    • Organizational update: In September 2023, Zai Lab appointed Robert J. Brown, M.D. as Chief Medical Officer, Oncology. Dr. Brown is an oncology drug development leader, with more than 16 years of translational, research, and clinical development expertise in the areas of oncology, immunology, and neurology. Dr. Brown reports to Dr. Rafael Amado, President, Head of Global Oncology Research and Development at Zai Lab, and provides strategic leadership and support with respect to the clinical development of our oncology pipeline.

    Anticipated Major Milestones in 2023 / 2024

    Oncology

    ZEJULA (niraparib, PARP)

    • Zai Lab to present the final OS analysis for the Phase 3 NORA study in Chinese patients with platinum-sensitive recurrent ovarian cancer at an upcoming medical conference in 2024.

    Tumor Treating Fields

    • NovoCure to submit a Premarket Approval Application with the FDA in second-line+ NSCLC post-platinum progression by the end of 2023.



    • NovoCure to provide a topline data readout from the phase 3 METIS clinical trial in brain metastases in the first quarter of 2024. We are participating in the study in Greater China.



    • NovoCure to provide a topline data readout from the phase 3 PANOVA-3 clinical trial in locally advanced pancreatic cancer in the second half of 2024. We are participating in the study in Greater China.

    Repotrectinib (ROS1/TRK)

    • Potential NMPA approval of the NDA in locally advanced or metastatic ROS1-positive NSCLC in 2024.

    KRAZATI (adagrasib, KRASG12C)

    • Zai Lab to submit an NDA to the NMPA in second-line+ KRASG12C-mutated NSCLC in 2024.

    Bemarituzumab (FGFR2b)

    • Zai Lab to join the global Phase 3 FORTITUDE-102 study of bemarituzumab in combination with nivolumab and chemotherapy in first-line gastric or gastroesophageal junction cancer in Greater China in the first half of 2024.

    ZL-1310 (DLL3 ADC)

    • Zai Lab to initiate a global Phase 1 study in relapsed and refractory second-line+ small cell lung cancer (SCLC) who have progressed after platinum-based treatment in the first quarter of 2024.

    Autoimmune Disorders, Infectious Disease, and Neuroscience

    Efgartigimod (FcRn)

    • argenx to report topline data from the registrational Phase 3 ADVANCE-SC trial of efgartigimod SC in immune thrombocytopenia (ITP) in the fourth quarter of 2023. We are participating in the study in Greater China.



    • argenx to report topline data from the registrational Phase 3 ADDRESS trial of efgartigimod SC in pemphigus around year-end 2023. We are participating in the study in Greater China.



    • argenx to file the supplemental BLA in CIDP by the end of 2023.



    • argenx to initiate a registrational study of efgartigimod in thyroid eye disease (TED) in the fourth quarter of 2023. We plan to participate in the program in Greater China in 2024.



    • Potential NMPA approval of the supplemental BLA for efgartigimod SC in gMG in 2024.

    KarXT (xanomeline-trospium, M1/M4-preferring muscarinic agonist)

    • Karuna to launch KarXT for the treatment of schizophrenia, if approved by the FDA, in the second half of 2024.

    XACDURO® (Sulbactam-Durlobactam)

    • Potential NMPA approval of the NDA in infections caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex in 2024.

    ZL-1102 (IL-17 Humabody®)

    • Zai Lab to initiate a global Phase 2 study in chronic plaque psoriasis in 2024.

    Conference Call and Webcast Information

    Zai Lab will host a live conference call and webcast tomorrow, November 8, 2023, at 8:00 a.m. ET. 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: https://register.vevent.com/register/BI87a7a83f6a6441279fddbaae217dd092

    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 (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, autoimmune disorders, infectious diseases, and neuroscience. Our goal is to leverage our competencies and resources to positively impact human health in China and worldwide.

    For additional information about Zai Lab, please visit www.zailaboratory.com or follow us at www.twitter.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, which 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 trends. 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 forward-looking statements relating to our strategy and plans; potential of and expectations for our business and pipeline programs; 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 future financial and operating results; and financial guidance, including with respect to our planned sources and uses of cash 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," "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 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.

    For more information, please contact:

    Investor Relations:

    Christine Chiou / Lina Zhang

    +1 (917) 886-6929 / +86 136 8257 6943

    [email protected] / [email protected]

    Media:

    Shaun Maccoun / Xiaoyu Chen

    +1 (415) 317-7255 / +86 185 0015 5011

    [email protected] / [email protected]

    Zai Lab Limited



    Zai Lab Limited

    Unaudited Condensed Consolidated Balance Sheets

    (In thousands of U.S. dollars ("$") except for number of shares and per share data)

      September 30,

    2023
     December 31,

    2022
    Assets    
    Current assets:    
    Cash and cash equivalents 788,806  1,008,470 
    Short-term investments 31,600  — 
    Accounts receivable (net of allowance for credit loss of $12 and $11 as of September 30, 2023 and December 31, 2022, respectively) 41,596  39,963 
    Notes receivable 23,679  8,608 
    Inventories, net 44,229  31,621 
    Prepayments and other current assets 29,821  35,674 
    Total current assets 959,731  1,124,336 
    Restricted cash, non-current 1,792  803 
    Long term investments 4,466  6,431 
    Prepayments for equipment 144  1,396 
    Property and equipment, net 55,282  57,863 
    Operating lease right-of-use assets 16,398  19,512 
    Land use rights, net 3,057  6,892 
    Intangible assets, net 1,568  1,511 
    Long-term deposits 1,256  1,396 
    Total assets 1,043,694  1,220,140 
    Liabilities and shareholders' equity    
    Current liabilities:    
    Accounts payable 55,020  65,974 
    Current operating lease liabilities 6,886  7,050 
    Other current liabilities 62,990  66,818 
    Total current liabilities 124,896  139,842 
    Deferred income 27,686  21,360 
    Non-current operating lease liabilities 9,808  13,343 
    Other non-current liabilities 325  — 
    Total liabilities 162,715  174,545 
    Commitments and contingencies     
    Shareholders' equity    
    Ordinary shares (par value of $0.000006 per share; 5,000,000,000 shares authorized; 973,930,280 and 962,455,850 shares issued as of September 30, 2023 and December 31, 2022, respectively; 969,037,150 and 960,219,570 shares outstanding as of September 30, 2023 and December 31, 2022, respectively) 6  6 
    Additional paid-in capital 2,954,362  2,893,120 
    Accumulated deficit (2,100,551) (1,861,360)
    Accumulated other comprehensive income 47,952  25,685 
    Treasury Stock (at cost, 4,893,130 and 2,236,280 shares as of September 30, 2023 and December 31, 2022, respectively) (20,790) (11,856)
    Total shareholders' equity 880,979  1,045,595 
    Total liabilities and shareholders' equity 1,043,694  1,220,140 



    Zai Lab Limited

    Unaudited Condensed Consolidated Statements of Operations

    (In thousands of $, except for number of shares and per share data)

      Three Months Ended

    September 30,
     Nine Months Ended

    September 30,
      2023 2022 2023 2022
    Revenues:        
    Product revenue, net 69,228  56,963  200,889  150,633 
    Collaboration revenue —  577  —  1,806 
    Total revenues 69,228  57,540  200,889  152,439 
    Expenses:        
    Cost of sales (25,479) (20,044) (70,579) (53,094)
    Research and development (58,767) (99,524) (183,920) (219,462)
    Selling, general, and administrative (68,552) (66,555) (198,982) (186,947)
    Gain on sale of intellectual property —  —  10,000  — 
    Loss from operations (83,570) (128,583) (242,592) (307,064)
    Interest income 9,172  3,872  29,493  5,235 
    Foreign currency gain (loss) 4,852  (40,442) (26,315) (73,052)
    Other income (expense), net 394  3,963  223  (6,415)
    Loss before income tax and share of loss from equity method investment (69,152) (161,190) (239,191) (381,296)
    Income tax expense —  —  —  — 
    Share of loss from equity method investment —  —  —  (221)
    Net loss (69,152) (161,190) (239,191) (381,517)
    Net loss attributable to ordinary shareholders (69,152) (161,190) (239,191) (381,517)
    Loss per share - basic and diluted (0.07) (0.17) (0.25) (0.40)
    Weighted-average shares used in calculating net loss per ordinary share - basic and diluted 968,767,730  959,085,960  965,060,570  957,439,910 
    Loss per American Depositary Shares ("ADS") - basic and diluted (0.71) (1.68) (2.48) (3.98)
    Weighted-average ADSs used in calculating net loss per ADS - basic and diluted 96,876,773  95,908,596  96,506,057  95,743,991 



    Zai Lab Limited

    Unaudited condensed consolidated statements of comprehensive loss

    (In thousands of $)

      Three Months Ended

    September 30,
     Nine Months Ended

    September 30,
      2023 2022 2023 2022
    Net loss (69,152) (161,190) (239,191) (381,517)
    Other comprehensive income, net of tax of nil:        
    Foreign currency translation adjustments (4,228) 35,062  22,267  63,194 
    Comprehensive loss (73,380) (126,128) (216,924) (318,323)



    Zai Lab Limited

    Non-GAAP Measures

    (In thousands of $)

      Three Months Ended

    September 30,
     Year over Year % Growth Nine Months Ended

    September 30,
     Year over Year % Growth
      2023

     2022

     As reported At CER* 2023

     2022

     As reported At CER*
    Product revenue, net 69,228  56,963  22% 27% 200,889  150,633  33% 41%
    Loss from operations (83,570) (128,583) (35)% (33)% (242,592) (307,064) (21)% (17)%

    * The growth rates at constant exchange rates (CER) were calculated assuming the same foreign currency exchange rates were in effect for the current and prior year periods. 



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    Officer Amado Rafael sold $188,039 worth of American Depositary Shares (10,787 units at $17.43) and converted options into 21,000 units of American Depositary Shares, increasing direct ownership by 24% to 52,391 units (SEC Form 4)

    4 - Zai Lab Ltd (0001704292) (Issuer)

    1/2/26 4:15:40 PM ET
    $ZLAB
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Chief Legal Officer Edmondson Frazor Titus Iii sold $148,278 worth of American Depositary Shares (8,651 units at $17.14), decreasing direct ownership by 31% to 19,086 units (SEC Form 4)

    4 - Zai Lab Ltd (0001704292) (Issuer)

    12/18/25 4:34:28 PM ET
    $ZLAB
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Chairperson & CEO Du Ying gifted 303,378 units of American Depositary Shares and received a gift of 377,520 units of American Depositary Shares, increasing direct ownership by 8% to 964,161 units (SEC Form 4)

    4 - Zai Lab Ltd (0001704292) (Issuer)

    12/12/25 4:42:08 PM ET
    $ZLAB
    Biotechnology: Pharmaceutical Preparations
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    $ZLAB
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    Zai Lab to Announce Fourth Quarter and Full Year 2025 Financial Results and Recent Corporate Updates on February 26, 2026

    - Company to host conference call and webcast on February 26, 2026, at 8:00 a.m. ET (9:00 p.m. HKT) Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688)) today announced that it will report its fourth quarter and full year 2025 financial results and provide recent corporate updates on February 26, 2026, before the opening of U.S. equity markets. The announcement will be followed by a conference call and webcast at 8:00 a.m. ET (9:00 p.m. HKT). Conference Call and Webcast Information The live webcast can be accessed 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 webc

    2/10/26 8:30:00 AM ET
    $ZLAB
    Biotechnology: Pharmaceutical Preparations
    Health Care

    $207B Market Shift: The Race for Fast Track Approval in Oncology

    Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Feb. 5, 2026 /PRNewswire/ -- USANewsGroup.com News Commentary – The FDA isn't just approving drugs; they are completely reshaping the landscape. In 2025 alone, the agency issued over 50 oncology approvals[1], but the real story is the aggressive pivot toward targeted therapies for high-unmet-need solid tumors. That momentum has accelerated in 2026 with a sudden flurry of expedited designations[2] for RAS inhibitors and rare malignancies. This regulatory velocity creates a clear validation framework, positioning Oncolytics Biotech Inc. (NASDAQ:ONCY), Relay Therapeutics (NASDAQ:RLAY), MAIA Biotechnology (NYSE-A: MAIA), Zai Lab (NASDAQ:

    2/5/26 9:35:00 AM ET
    $AVBP
    $ONCY
    $RLAY
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Biotechnology: Biological Products (No Diagnostic Substances)

    Zai Lab Highlights Strategic Priorities and Global Pipeline Progress at 44th Annual J.P. Morgan Healthcare Conference

    - Zocilurtatug pelitecan (Zoci) positioned to become Zai Lab's first global oncology launch, with three registration-enabling studies across 2L+ SCLC, 1L SCLC and NEC by the end of 2026 - Rapidly advancing a differentiated global pipeline, including ZL-1503 (IL-13xIL-31), ZL-6201 (LRRC15 ADC), ZL-1222 (PD-1xIL-12) and ZL-1311 (MUC17xCD3) - COBENFY approved in China, with commercial launch expected in 1H 2026 - Zai Lab to present at the J.P. Morgan Annual Healthcare Conference on Tuesday, January 13, 2026, at 3:00 p.m. PT / 6:00 p.m. ET Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688)) today provided an update on the Company's 2026 strategic priorities and clinical development progress. The

    1/13/26 8:00:00 AM ET
    $ZLAB
    Biotechnology: Pharmaceutical Preparations
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    $ZLAB
    SEC Filings

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    SEC Form SCHEDULE 13G filed by Zai Lab Limited

    SCHEDULE 13G - Zai Lab Ltd (0001704292) (Subject)

    2/17/26 8:56:19 AM ET
    $ZLAB
    Biotechnology: Pharmaceutical Preparations
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    Amendment: SEC Form SCHEDULE 13G/A filed by Zai Lab Limited

    SCHEDULE 13G/A - Zai Lab Ltd (0001704292) (Subject)

    2/13/26 5:32:38 PM ET
    $ZLAB
    Biotechnology: Pharmaceutical Preparations
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    Amendment: SEC Form SCHEDULE 13G/A filed by Zai Lab Limited

    SCHEDULE 13G/A - Zai Lab Ltd (0001704292) (Subject)

    2/10/26 1:49:22 PM ET
    $ZLAB
    Biotechnology: Pharmaceutical Preparations
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    $ZLAB
    Large Ownership Changes

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    SEC Form SC 13G filed by Zai Lab Limited

    SC 13G - Zai Lab Ltd (0001704292) (Subject)

    11/14/24 11:11:39 AM ET
    $ZLAB
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Amendment: SEC Form SC 13G/A filed by Zai Lab Limited

    SC 13G/A - Zai Lab Ltd (0001704292) (Subject)

    11/8/24 10:52:38 AM ET
    $ZLAB
    Biotechnology: Pharmaceutical Preparations
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    SEC Form SC 13G/A filed by Zai Lab Limited (Amendment)

    SC 13G/A - Zai Lab Ltd (0001704292) (Subject)

    6/6/24 9:54:34 AM ET
    $ZLAB
    Biotechnology: Pharmaceutical Preparations
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    $ZLAB
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    Zai Lab to Announce Fourth Quarter and Full Year 2025 Financial Results and Recent Corporate Updates on February 26, 2026

    - Company to host conference call and webcast on February 26, 2026, at 8:00 a.m. ET (9:00 p.m. HKT) Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688)) today announced that it will report its fourth quarter and full year 2025 financial results and provide recent corporate updates on February 26, 2026, before the opening of U.S. equity markets. The announcement will be followed by a conference call and webcast at 8:00 a.m. ET (9:00 p.m. HKT). Conference Call and Webcast Information The live webcast can be accessed 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 webc

    2/10/26 8:30:00 AM ET
    $ZLAB
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Zai Lab Announces Updated Phase 1 Data for Zocilurtatug Pelitecan (formerly ZL-1310), Demonstrating Potential as a First-in-Class/Best-in-Class DLL3-Targeted ADC for Small Cell Lung Cancer, and Initiation of Global Phase 3 Registrational Study

    - Robust responses observed in heavily pre-treated patients with a 68% ORR for 1.6 mg/kg in second-line setting -Compelling activity in patients with baseline brain metastases (n=32), including an 80% ORR for patients without prior brain radiotherapy - Duration of response of 6.1 months across all doses and all lines of therapy; enrollment continuing for 1.2 mg/kg and 1.6 mg/kg, with nearly half of responders ongoing at data cut-off - Potential best-in-class safety profile with a low rate of Grade ≥3 TRAEs and no discontinuations in the 1.6mg/kg cohort - Global Phase 3 trial, ZL-1310-003, has initiated in second-line plus small cell lung cancer (SCLC); first-line SCLC and neuroendoc

    10/24/25 9:00:00 AM ET
    $ZLAB
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Zai Lab to Announce Third Quarter 2025 Financial Results and Recent Corporate Updates on November 6, 2025

    - Company to host conference call and webcast on November 6, 2025, at 8:00 a.m. ET (9:00 p.m. HKT) Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688)) today announced that it will report its third quarter 2025 financial results and provide recent corporate updates on November 6, 2025, before the opening of U.S. equity markets. The announcement will be followed by a conference call and webcast at 8:00 a.m. ET (9:00 p.m. HKT). Conference Call and Webcast Information The live webcast can be accessed 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):

    10/15/25 7:30:00 AM ET
    $ZLAB
    Biotechnology: Pharmaceutical Preparations
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    $ZLAB
    Leadership Updates

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    The Institute for Follicular Lymphoma Innovation (IFLI) Appoints Innovative Leaders Mehrdad Mobasher, M.D., M.P.H., and Carol O'Hear, M.D., Ph.D., as Executive Partners

    DIAMOND BAR, Calif., Oct. 21, 2025 /PRNewswire/ -- The Institute for Follicular Lymphoma Innovation (IFLI), a global, non-profit, private foundation dedicated to accelerating the development of innovative treatment options for patients with follicular lymphoma (FL)., today announced the appointments of Mehrdad Mobasher, M.D., M.P.H., and Carol O'Hear, M.D., Ph.D., as Executive Partners. "I believe Carol and Mehrdad will be exceptional partners to the IFLI team and portfolio as they bring decades of strategic leadership and drug development expertise," said David McCullagh, Man

    10/21/25 8:05:00 AM ET
    $CRVS
    $DNA
    $EXEL
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Biotechnology: Biological Products (No Diagnostic Substances)

    Zai Lab Announces Dr. Harald Reinhart to Retire as Head of Global Development for Neuroscience, Autoimmune and Infectious Diseases; Dr. Rafael Amado to be Appointed President, Head of Global R&D

      Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))) announced today that following a distinguished career, Harald Reinhart, M.D., President, Head of Global Development, Neuroscience, Autoimmune and Infectious Diseases (NSAiID) of Zai Lab, will retire at the end of June, after which he will serve as a senior advisor for the Company. Rafael Amado, M.D., President, Head of Global Oncology Research and Development of Zai Lab, will expand his role and assume responsibility for all of the Company's Global R&D upon Dr. Reinhart's retirement. "Harald has devoted nearly 50 years to treating patients, first as a physician and later discovering and developing innovative therapies to bring to patients in

    6/11/24 4:05:00 PM ET
    $ZLAB
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Zai Lab Appoints Michel Vounatsos To Its Board of Directors

    SHANGHAI and CAMBRIDGE, Mass., Jan. 09, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))) today announced that Michel Vounatsos has been appointed to its Board of Directors, effective January 7, 2023. Mr. Vounatsos brings to the Board extensive global leadership and management experience in the biopharmaceutical industry, including more than 25 years of service at leading companies. His expertise includes significant commercial experience in China and worldwide in the areas of primary care and neuroscience. "We are delighted to welcome Michel Vounatsos to the Zai Lab Board of Directors," said Dr. Samantha Du, Founder, Chairperson, and CEO of Zai Lab. "Michel has a wealt

    1/9/23 7:30:00 AM ET
    $ZLAB
    Biotechnology: Pharmaceutical Preparations
    Health Care