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Articles from Zai Lab Limited

Zai Lab to Announce Fourth Quarter and Full Year 2024 Financial Results and Provide Recent Corporate Updates on February 27, 2025
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that it will report its fourth quarter and full year 2024 financial results and provide recent corporate updates on February 27, 2025, before the opening of the 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).
By Zai Lab Limited · Via Business Wire · January 28, 2025
Zai Lab Receives Orphan Drug Designation from the U.S. FDA for ZL-1310 (DLL3 ADC) for the Treatment of Small Cell Lung Cancer (SCLC)
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ZL-1310, a potential highly active first-in-class DLL3 antibody-drug conjugate (ADC), for the treatment of small cell lung cancer (SCLC).
By Zai Lab Limited · Via Business Wire · January 22, 2025
Zai Lab Announces Acceptance of New Drug Application for KarXT for the Treatment of Schizophrenia
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that China’s National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for KarXT for the treatment of schizophrenia in adults.
By Zai Lab Limited · Via Business Wire · January 17, 2025
Zai Lab Announces Positive Topline Results for TIVDAK in the China Subpopulation of the Global Phase 3 innovaTV 301 Trial in Patients with Recurrent or Metastatic Cervical Cancer
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced positive topline results from the China subpopulation of the global Phase 3 innovaTV 301 study, demonstrating a clinically meaningful improvement in overall survival with TIVDAK treatment for patients with previously treated recurrent or metastatic cervical cancer compared to chemotherapy.
By Zai Lab Limited · Via Business Wire · January 15, 2025
Zai Lab and Vertex Announce Strategic Agreement to Develop and Commercialize Povetacicept in Mainland China, Hong Kong SAR, Macau SAR, Taiwan region and Singapore
Zai Lab Limited (Nasdaq: ZLAB; HKEX: 9688) and Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced an exclusive collaboration and license agreement for the development and commercialization of Vertex’s povetacicept (pove) in mainland China, Hong Kong SAR, Macau SAR, Taiwan region and Singapore (the licensed territory). Pove is a recombinant fusion protein therapeutic and dual antagonist of BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) with best-in-class potential being studied for the treatment of Immunoglobulin A nephropathy (IgAN) and other B cell-mediated diseases.
By Zai Lab Limited · Via Business Wire · January 10, 2025
Zai Lab Announces Strategic Partnership with MediLink Therapeutics to Develop a Novel LRRC15 Antibody-Drug Conjugate
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced a new strategic collaboration and worldwide license agreement with MediLink Therapeutics (Suzhou) Co., Ltd. (“MediLink”) to use MediLink’s TMALIN® antibody-drug conjugate (ADC) platform for the development of a novel LRRC15 ADC, ZL-6201, consisting of an antibody discovered by Zai Lab.
By Zai Lab Limited · Via Business Wire · January 9, 2025
Zai Lab Announces Participation in Investor Conference in January 2025
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that members of the Company’s senior management team will participate in the following investor conference in January 2025:
By Zai Lab Limited · Via Business Wire · December 12, 2024
Zai Lab Announces the Inclusion of AUGTYRO® (repotrectinib) for ROS1+ NSCLC and Other Updates in China’s National Reimbursement Drug List
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the 2024 National Reimbursement Drug List (NRDL) released by China’s National Healthcare Security Administration (NHSA) has been updated to include the following medicines and indications:
By Zai Lab Limited · Via Business Wire · November 27, 2024
Zai Lab Announces Anticipated Closing of Public Offering of American Depositary Shares and Full Exercise of Underwriters' Option to Purchase Additional American Depositary Shares
Zai Lab Limited (“Zai Lab” or the “Company”) (NASDAQ: ZLAB; HKEX: 9688), an innovative, commercial-stage biopharmaceutical company, today announced the anticipated closing of its previously announced underwritten public offering of 7,843,137 American depositary shares (“ADSs”), each representing ten ordinary shares of the Company, at a price of US$25.50 per ADS. In addition, Zai Lab today announced that the underwriters in the offering fully exercised their option to purchase an additional 1,176,470 ADSs at the public offering price, less underwriting discounts and commissions. The sale of additional ADSs pursuant to the exercise of the option to purchase additional ADSs is expected to close on November 19, 2024, subject to customary closing conditions.
By Zai Lab Limited · Via Business Wire · November 18, 2024
Zai Lab Announces Pricing of Public Offering of American Depositary Shares
Zai Lab Limited (“Zai Lab” or the “Company”) (NASDAQ: ZLAB; HKEX: 9688), an innovative, commercial-stage biopharmaceutical company, today announced the pricing of its underwritten public offering of 7,843,137 American depositary shares (“ADSs”), each representing ten ordinary shares of the Company, at a price of US$25.50 per ADS.
By Zai Lab Limited · Via Business Wire · November 14, 2024
Zai Lab Announces Proposed Public Offering of American Depositary Shares
Zai Lab Limited (“Zai Lab” or the “Company”) (NASDAQ: ZLAB; HKEX: 9688), an innovative, commercial-stage biopharmaceutical company, today announced that it has commenced an underwritten public offering of $200.0 million of American depositary shares (“ADSs”), each representing ten ordinary shares of the Company with a par value of $0.000006 per share. All ADSs will be offered by Zai Lab. Zai Lab expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the ADSs sold in the public offering at the public offering price less underwriting discounts and commissions. Zai Lab intends to use the net proceeds from this offering for general corporate purposes.
By Zai Lab Limited · Via Business Wire · November 13, 2024
Zai Lab Announces Third Quarter 2024 Financial Results and Recent Corporate Updates
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced financial results for the third quarter of 2024, along with recent product highlights and corporate updates.
By Zai Lab Limited · Via Business Wire · November 12, 2024
Zai Lab and argenx Announce Approval of VYVGART Hytrulo for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in China
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) and argenx (Euronext & Nasdaq: ARGX) today announced that China’s National Medical Products Administration (NMPA) approved the supplemental Biologics License Application (sBLA) for VYVGART Hytrulo 1,000mg (5.6ml)/vial [Efgartigimod Alfa Injection (Subcutaneous Injection)] for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP). VYVGART Hytrulo is approved for CIDP as a once weekly 30-to-90 second subcutaneous injection. It is the first and only therapy approved in China for the treatment of CIDP, a debilitating, often progressive, immune-mediated neuromuscular disorder of the peripheral nervous system.
By Zai Lab Limited · Via Business Wire · November 11, 2024
Zai Lab Reports Positive Topline Data from Phase 3 Bridging Trial Evaluating KarXT for the Treatment of Schizophrenia in China
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced positive topline results from the company’s Phase 3 multi-center trial evaluating the safety and efficacy of KarXT (xanomeline and trospium chloride) in China. Consistent with previous global studies, the registrational bridging trial met its primary endpoint, with KarXT demonstrating a statistically significant 9.2-point reduction in the Positive and Negative Syndrome Scale (PANSS) total score compared to placebo at Week 5 (-16.9 KarXT vs. -7.7 placebo, p=0.0014).
By Zai Lab Limited · Via Business Wire · October 29, 2024
ZL-1310, an Investigational DLL3-Targeted Antibody-Drug Conjugate (ADC), Demonstrates Promising Objective Response Rates and Safety Profile in Extensive-Stage Small Cell Lung Cancer
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today presented data from the ongoing global Phase 1a/1b study of ZL-1310, a potential best-in-class next-generation antibody-drug conjugate (ADC), at the EORTC-NCI-AACR (ENA) Symposium 2024 in Barcelona, Spain, as an oral presentation during the plenary session. ZL-1310 is being tested in patients with previously treated extensive-stage Small Cell Lung Cancer (ES-SCLC) after at least one prior platinum-based chemotherapy regimen.
By Zai Lab Limited · Via Business Wire · October 24, 2024
Zai Lab Announces Participation in November and December Investor Conferences
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that members of the Company’s senior management team will participate in the following investor conferences in November and December 2024:
By Zai Lab Limited · Via Business Wire · October 18, 2024
Zai Lab to Host Webcast Presentation to Discuss Data from Early Clinical Program Evaluating Its Investigational DLL3-Targeted Antibody-Drug Conjugate (ADC) ZL-1310
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that it will hold an investor webcast to discuss data from a Phase 1 clinical trial of ZL-1310, the Company’s investigational DLL3-targeted antibody-drug conjugate (ADC), in patients with advanced stage small cell lung cancer (SCLC). The live conference call and webcast will take place on Thursday, October 24, 2024, at 8:30 a.m. ET (8:30 p.m. HKT).
By Zai Lab Limited · Via Business Wire · October 17, 2024
Zai Lab to Announce Third Quarter 2024 Financial Results and Recent Corporate Updates on November 12, 2024
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that it will report financial results for the third quarter of 2024 and recent corporate updates, before the opening of the U.S. equity markets on Tuesday, November 12, 2024. The Company will host a live conference call and webcast on the same date, at 8:00 a.m. ET (9:00 p.m. HKT).
By Zai Lab Limited · Via Business Wire · October 16, 2024
Zai Lab to Present Data from Phase 1 Trial of ZL-1310, Its Investigational Antibody-Drug Conjugate (ADC) for DLL3+ Solid Tumors, at EORTC-NCI-AACR Symposium (ENA) 2024
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688; “Zai Lab”) today announced that data from a Phase 1 study of ZL-1310, the Company’s investigational antibody-drug conjugate (ADC), will be presented during a plenary session at the EORTC-NCI-AACR Symposium (ENA) 2024 taking place October 23-25, in Barcelona, Spain. The preliminary results from the ongoing, open-label, multicenter clinical trial (NCT06179069) will address the potential of ZL-1310 as a novel treatment for small cell lung cancer (SCLC).
By Zai Lab Limited · Via Business Wire · October 9, 2024
Zai Lab to Present Preclinical Data of ZL-1503, an IL-13/IL-31 Bispecific Antibody for the Treatment of Atopic Dermatitis, at EADV Congress 2024
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688; “Zai Lab”) today announced that data from a preclinical study of ZL-1503, the company’s internally discovered IL-13/IL-31 bispecific antibody for the treatment of atopic dermatitis (AD), will be presented in a late-breaking oral presentation at the European Academy of Dermatology and Venerology Congress (EADV) 2024 taking place September 25-28 in Amsterdam, Netherlands. The results will address the potential of ZL-1503 as a novel treatment for moderate-to-severe atopic dermatitis, as well as other diseases involving the IL-13 and IL-31 pathways.
By Zai Lab Limited · Via Business Wire · September 17, 2024
Zai Lab to Present Preliminary Data From Phase 1 Trial of ZL-1218, an Investigational Anti-CCR8 Antibody for the Treatment of Advanced Solid Tumors, at ESMO Congress 2024
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that data from a Phase 1 study of ZL-1218, the company’s anti-CCR8 antibody, will be presented in a poster session at the European Society for Medical Oncology (ESMO) Congress 2024 taking place September 13-17, 2024, in Barcelona, Spain. The preliminary results from the ongoing dose-escalation clinical trial (NCT05859464) will highlight the potential of ZL-1218 to reduce regulatory T cells and modulate T-cell function in the tumor microenvironment (TME) of advanced solid tumors.
By Zai Lab Limited · Via Business Wire · August 27, 2024
Zai Lab Announces Participation in September Investor Conferences
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that members of the Company’s senior management team will participate in the following investor conferences in September 2024:
By Zai Lab Limited · Via Business Wire · August 22, 2024
Zai Lab Announces Second Quarter 2024 Financial Results and Recent Corporate Updates
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced financial results for the second quarter of 2024, along with recent product highlights and corporate updates.
By Zai Lab Limited · Via Business Wire · August 6, 2024
Zai Lab and argenx Announce Approval of Efgartigimod Alfa Injection (Subcutaneous Injection) for Generalized Myasthenia Gravis in China
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) and argenx (Euronext & Nasdaq: ARGX) today announced that China’s National Medical Products Administration (NMPA) approved the Biologics License Application (BLA) for efgartigimod alfa injection (subcutaneous injection) (efgartigimod SC), 1,000mg (5.6ml)/vial indicated as an add on to standard therapy for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.
By Zai Lab Limited · Via Business Wire · July 16, 2024
Zai Lab-Supported Study Published in Cell Provides New Insights with Potential to Improve Treatment of HRD-Positive Ovarian Cancers, Including Through Combination PARP Inhibitor and CCR8 Therapy
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that data published in the journal Cell demonstrate that neoadjuvant monotherapy with the poly (ADP-ribose) polymerase (PARP) inhibitor niraparib results in a high response rate and reshapes the tumor microenvironment (TME), providing new targets for immunotherapy and combination regimens in patients with homologous recombination deficiency (HRD) positive ovarian cancer. The study revealed niraparib preferentially suppresses certain immune cells that support the growth of HRD-positive ovarian tumors.
By Zai Lab Limited · Via Business Wire · July 15, 2024
Zai Lab to Announce Second Quarter 2024 Financial Results and Recent Corporate Updates on August 6, 2024
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that it will report financial results for the second quarter of 2024 and recent corporate updates, after the closing of the U.S. equity markets on Tuesday, August 6, 2024. The Company will host a live conference call and webcast on Wednesday, August 7, 2024, at 8:00 a.m. ET (8:00 p.m. HKT).
By Zai Lab Limited · Via Business Wire · July 10, 2024
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.
By Zai Lab Limited · Via Business Wire · June 11, 2024
Zai Lab Initiates Global Phase 2 Clinical Trial Evaluating ZL-1102 As a Topical Treatment for Chronic Plaque Psoriasis
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the first patient has been dosed in a global Phase 2 clinical trial (NCT06380907) evaluating the efficacy and safety of the company’s internally developed anti-IL-17 investigational therapy, ZL-1102, for the treatment of chronic plaque psoriasis (CPP). ZL-1102 is a novel human VH antibody fragment (Humabody®) targeting the IL-17 cytokine. Emphasizing its unique approach, ZL-1102 is being developed as a topical treatment for mild-to-moderate CPP, differentiating it from other anti-IL-17 products that target moderate-to-severe forms of the disease through systemic administration.
By Zai Lab Limited · Via Business Wire · May 22, 2024
Zai Lab and Innoviva Specialty Therapeutics Announce NMPA Approval for XACDURO® (Sulbactam-Durlobactam or SUL-DUR) for Hospital-Acquired and Ventilator-Associated Pneumonia Caused by Acinetobacter Baumannii-Calcoaceticus Complex in China
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) and Innoviva Specialty Therapeutics today announced that China’s National Medical Products Administration (NMPA) has approved Zai Lab’s New Drug Application (NDA) for XACDURO® (sulbactam-durlobactam) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex in patients 18 years of age and older. The World Health Organization considers Acinetobacter a top-priority pathogen worldwide that needs novel antibiotics1.
By Zai Lab Limited · Via Business Wire · May 20, 2024
Zai Lab Announces Participation in May and June Investor Conferences
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that members of the Company’s senior management team will participate in the following investor conferences in May and June 2024:
By Zai Lab Limited · Via Business Wire · May 16, 2024
Zai Lab Announces Acceptance of Supplemental Biologics License Application with Priority Review for Efgartigimod Alfa Injection (Subcutaneous Injection) in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in China
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the supplemental Biologics License Application (sBLA) for efgartigimod alfa injection (subcutaneous injection) (efgartigimod SC) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP). The CDE granted priority review on May 11, 2024 and Breakthrough Therapy Designation for efgartigimod SC for the treatment of patients with CIDP on September 18, 2023.
By Zai Lab Limited · Via Business Wire · May 14, 2024
Zai Lab Announces Approval of AUGTYRO™ (repotrectinib) for Patients with ROS1-positive NSCLC by China’s NMPA
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the National Medical Products Administration (NMPA) in China has approved the New Drug Application (NDA) for AUGTYRO™ (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC). The approval is based on the pivotal TRIDENT-1 study, an open-label, single-arm, Phase 1/2 trial that evaluated repotrectinib in TKI-naïve and TKI-pretreated patients with ROS1-positive NSCLC.
By Zai Lab Limited · Via Business Wire · May 12, 2024
Zai Lab Announces First Quarter 2024 Financial Results and Recent Corporate Updates
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced financial results for the first quarter of 2024, along with recent product highlights and corporate updates.
By Zai Lab Limited · Via Business Wire · May 8, 2024
Zai Lab to Announce First Quarter 2024 Financial Results and Recent Corporate Updates on May 8, 2024
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that it will report financial results for the first quarter of 2024 and recent corporate updates, after the closing of the U.S. equity markets on Wednesday, May 8, 2024. The Company will host a live conference call and webcast on Thursday, May 9, 2024, at 8:00 a.m. ET (8:00 p.m. HKT).
By Zai Lab Limited · Via Business Wire · April 15, 2024
Zai Lab Statement on Executive Management Team’s Agreement on Share Activities
The Executive Officers of Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), Samantha Du, Josh Smiley, Rafael Amado, Harald Reinhart, Yajing Chen, F. Ty Edmondson, as well as Jonathan Wang, today announced that they have each agreed that they do not anticipate selling any shares in Zai Lab through the remainder of 2024, except for any shares in existing Rule 10b5-1 plans that are currently effective or to cover tax obligations associated with the vesting of equity awards.
By Zai Lab Limited · Via Business Wire · April 11, 2024
Zai Lab Presentations at AACR 2024 Annual Meeting to Showcase Ongoing Clinical Studies in Key Global Oncology Programs
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that two poster presentations highlighting ongoing global clinical studies in its oncology pipeline will be presented at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2024 taking place April 5-10, 2024, in San Diego, California.
By Zai Lab Limited · Via Business Wire · April 2, 2024
Zai Lab Partner Bristol Myers Squibb Announces Pivotal KRYSTAL-12 Confirmatory Trial Evaluating KRAZATI (adagrasib) Meets Primary Endpoint of Progression-Free Survival for Patients with Pretreated KRASG12C-Mutated Locally Advanced or Metastatic...
 
By Zai Lab Limited · Via Business Wire · April 1, 2024
Zai Lab Partner Novocure Announces METIS Phase 3 Clinical Trial Met Primary Endpoint, Demonstrating a Statistically Significant Extension in Time to Intracranial Progression for Patients with Brain Metastases from Non-Small Cell Lung Cancer
Zai Lab Limited (Nasdaq: ZLAB; HKEX: 9688) partner Novocure (NASDAQNVCR) today announced the phase 3 METIS clinical trial met its primary endpoint, demonstrating a statistically significant improvement in time to intracranial progression for adult patients treated with Tumor Treating Fields (TTFields) therapy and supportive care compared to supportive care alone in the treatment of patients with 1-10 brain metastases from non-small cell lung cancer (NSCLC) following stereotactic radiosurgery (SRS). Patients treated with TTFields therapy and supportive care exhibited a median time to intracranial progression of 21.9 months compared to 11.3 months in patients treated with supportive care alone for brain metastasis (n=298; hazard ratio=0.67; P=0.016). Median TTFields therapy treatment duration was 16 weeks and median usage was 67%. Consistent with previous studies, TTFields therapy was well-tolerated with sustained quality of life and neurocognitive function. Baseline characteristics were well balanced between arms.
By Zai Lab Limited · Via Business Wire · March 27, 2024
Zai Lab to Present Data Highlighting ZL-1310, a Novel Antibody-Drug Conjugate (ADC) for Treatment of Solid Tumors
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that it will present findings from preclinical studies highlighting the therapeutic potential of ZL-1310, the company’s global next-generation antibody-drug conjugate (ADC) program. The preclinical profile of ZL-1310 will be the focus of a poster presentation at the European Lung Cancer Congress 2024 (ELCC 2024), scheduled for March 20-23, 2024 in Prague, Czech Republic.
By Zai Lab Limited · Via Business Wire · March 13, 2024
Zai Lab to Present Final Overall Survival (OS) Data from Phase 3 NORA Study of ZEJULA (niraparib) in Platinum-Sensitive Recurrent Ovarian Cancer (PSROC)
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the final overall survival (OS) data from the Phase 3 randomized, double-blind, placebo-controlled NORA study evaluating ZEJULA® (niraparib) in Chinese patients with platinum-sensitive recurrent ovarian cancer (PSROC) will be shared in oral presentations at the 2024 Congress of the European Society of Gynaecological Oncology (ESGO), March 7-10, 2024, in Barcelona, Spain, and the 2024 Society for Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer, taking place March 16-18, 2024, in San Diego, CA.
By Zai Lab Limited · Via Business Wire · March 6, 2024
Zai Lab Announces Participation in March Investor Conference
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that members of the Company’s senior management team will participate in the following investor conference in March 2024:
By Zai Lab Limited · Via Business Wire · March 6, 2024
Zai Lab Announces Full-Year 2023 Financial Results and Recent Corporate Updates
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced financial results for full-year 2023, along with recent product highlights and corporate updates.
By Zai Lab Limited · Via Business Wire · February 27, 2024
Zai Lab to Announce Full-Year 2023 Financial Results and Recent Corporate Updates on February 27, 2024
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that it will report financial results for the year ended December 31, 2023 and recent corporate updates, after the closing of the U.S. equity markets on Tuesday, February 27, 2024. The Company will host a live conference call and webcast on Wednesday, February 28, 2024, at 8:00 a.m. ET (9:00 p.m. HKT).
By Zai Lab Limited · Via Business Wire · January 25, 2024
Zai Lab Announces The New England Journal of Medicine Publication Demonstrating Durable Clinical Activity of Repotrectinib in Patients with Advanced ROS1 Fusion-Positive NSCLC
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced The New England Journal of Medicine (NEJM) has published data from the registrational Phase 1/2 TRIDENT-1 study evaluating repotrectinib (TPX-0005) in patients with ROS1 fusion-positive (ROS1+) non-small cell lung cancers (NSCLCs). Repotrectinib is a tyrosine kinase inhibitor (TKI) that has shown robust anti-tumor activity against ROS1+ cancers in preclinical models. In the TRIDENT-1 study, repotrectinib demonstrated high response rates and durable activity in patients with ROS1+ NSCLC, including patients with TKI-naïve and TKI-pretreated tumors, ROS1 G2032R resistance mutations and brain metastases. Treatment with repotrectinib was generally well tolerated with a manageable safety profile compatible with long-term administration.
By Zai Lab Limited · Via Business Wire · January 10, 2024
Zai Lab Announces Participation in January Investor Conference
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that members of the Company’s senior management team will participate in the following investor conference in January 2024:
By Zai Lab Limited · Via Business Wire · December 19, 2023
Zai Lab Announces the First Listing of VYVGART® (efgartigimod alfa injection) and Other Updates in China’s National Reimbursement Drug List
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the 2023 National Reimbursement Drug List (NRDL) released by China’s National Healthcare Security Administration (NHSA) has been updated to include the following medicines and indications:
By Zai Lab Limited · Via Business Wire · December 12, 2023
Zai Lab Announces Third Quarter 2023 Financial Results and Recent Corporate Updates
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.
By Zai Lab Limited · Via GlobeNewswire · November 7, 2023
Zai Lab Announces Participation in November Investor Conferences
SHANGHAI, China and CAMBRIDGE, Mass., Oct. 26, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that members of the Company’s senior management team will participate in the following investor conferences in November 2023:
By Zai Lab Limited · Via GlobeNewswire · October 26, 2023
Zai Lab to Announce Third Quarter 2023 Financial Results and Recent Corporate Updates on November 7, 2023
- Company to Host Conference Call and Webcast on November 8, 2023, at 8:00 a.m. ET
By Zai Lab Limited · Via GlobeNewswire · October 18, 2023
Zai Lab Obtains Breakthrough Therapy Designation for Efgartigimod Alfa Injection (Subcutaneous Injection) in Patients with Chronic Inflammatory Demyelinating Polyneuropathy in China
SHANGHAI, China and CAMBRIDGE, Mass., Sept. 18, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted Breakthrough Therapy Designation for efgartigimod alfa injection (subcutaneous injection) (efgartigimod SC) for the treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP). The Breakthrough Therapy Designation for efgartigimod SC was supported by data from both global and Chinese patients enrolled in the ADHERE study.
By Zai Lab Limited · Via GlobeNewswire · September 18, 2023
Zai Lab Announces Breakthrough Therapy Designation Granted for Repotrectinib for Treatment of Patients with NTRK-positive TKI-pretreated advanced solid tumors in China
Candidate precision medicine has shown encouraging clinical activity for both ROS1-positive NSCLC and NTRK fusion-positive advanced solid tumors
By Zai Lab Limited · Via GlobeNewswire · August 30, 2023
Zai Lab Announces Participation in September Investor Conferences
SHANGHAI, China and CAMBRIDGE, Mass., Aug. 29, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that members of the company’s senior management team will participate in the following investor conferences in September 2023:
By Zai Lab Limited · Via GlobeNewswire · August 29, 2023
Zai Lab Announces Second Quarter 2023 Financial Results and Corporate Updates
SHANGHAI, China and CAMBRIDGE, Mass., Aug. 07, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced financial results for the second quarter of 2023, along with recent product highlights and corporate updates.
By Zai Lab Limited · Via GlobeNewswire · August 7, 2023
Zai Lab to Announce Second Quarter 2023 Financial Results and Corporate Updates on August 7, 2023
- Company to Host Conference Call and Webcast on August 8, 2023, at 8:00 a.m. ET
By Zai Lab Limited · Via GlobeNewswire · July 20, 2023
JAMA Oncology Publishes Data from Zai Lab Study Demonstrating Significant Reduction in Disease Progression or Death with ZEJULA (Niraparib) Maintenance Therapy in Broad Population of Advanced Ovarian Cancer Patients
The Phase 3 PRIME study demonstrates that treatment with ZEJULA significantly extends progression-free survival versus placebo and reduces the risk of disease progression or death by 55%    Findings confirm the benefit of ZEJULA monotherapy as first-line maintenance treatment, regardless of residual disease or biomarker status, in patients with newly diagnosed advanced ovarian cancer
By Zai Lab Limited · Via GlobeNewswire · July 19, 2023
Zai Lab and argenx Report Positive Topline Data from ADHERE Study of VYVGART Hytrulo in Patients with Chronic Inflammatory Demyelinating Polyneuropathy
SHANGHAI, China and CAMBRIDGE, Mass., July 17, 2023 (GLOBE NEWSWIRE) --  Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) and argenx SE (Euronext & Nasdaq: ARGX) today announced positive topline results from the ADHERE study evaluating VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in adults with chronic inflammatory demyelinating polyneuropathy (CIDP). The study met its primary endpoint (p=0.000039), demonstrating a significantly lower risk of relapse with VYVGART Hytrulo compared to placebo. Detailed data from ADHERE will be presented at an upcoming medical meeting.
By Zai Lab Limited · Via GlobeNewswire · July 17, 2023
Zai Lab Announces First Patient Treated in Mainland China for the Global Phase 3 FORTITUDE-101 Study of Bemarituzumab in First-Line Gastric Cancer
SHANGHAI, China and CAMBRIDGE, Mass., July 14, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the first patient has been treated in the mainland China portion of the global registrational, Phase 3 FORTITUDE-101 study for bemarituzumab, a potential first-in-class Fc-optimized monoclonal antibody that is designed to block fibroblast growth factors from binding and activating Fibroblast Growth Factor Receptor 2b (FGFR2b), inhibiting several downstream pro-tumor signaling pathways and potentially slowing tumor proliferation. FORTITUDE-101 is a global trial of bemarituzumab in first-line gastric cancer sponsored by Amgen.
By Zai Lab Limited · Via GlobeNewswire · July 14, 2023
Zai Lab Announces Acceptance by China’s NMPA of the BLA for Efgartigimod Alfa Injection (Subcutaneous Injection) for Patients with Generalized Myasthenia Gravis
SHANGHAI, China and CAMBRIDGE, Mass., July 10, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that China’s National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for efgartigimod alfa injection (subcutaneous (SC) injection, 1000mg (5.6ml)/vial) for the treatment of adult patients with generalized myasthenia gravis (gMG).
By Zai Lab Limited · Via GlobeNewswire · July 10, 2023
Zai Lab Announces Promotion of Yajing Chen to Chief Financial Officer
SHANGHAI, China and CAMBRIDGE, Mass., July 06, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced the promotion of Yajing Chen to Chief Financial Officer (CFO), effective July 7, 2023. Dr. Chen, currently Zai Lab’s Deputy CFO based in Cambridge, MA, has been supporting the Company’s finance function since joining in September 2021. She is a seasoned finance executive with more than 20 years of experience in the life sciences industry as well as a Ph.D. trained scientist. She succeeds Billy Cho, who will be stepping down from his role and will be pursuing a significant opportunity in private equity.
By Zai Lab Limited · Via GlobeNewswire · July 6, 2023
Zai Lab and argenx Announce Approval of VYVGART® (efgartigimod alfa injection) for Generalized Myasthenia Gravis in China
First-and-only approved FcRn antagonist for gMG patients by NMPA
By Zai Lab Limited · Via GlobeNewswire · June 30, 2023
Zai Lab Announces NDA Acceptance of Repotrectinib for Patients with ROS1-positive NSCLC by China’s NMPA
SHANGHAI, China and CAMBRIDGE, Mass., June 28, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the National Medical Products Administration (NMPA) in China has accepted the New Drug Application (NDA) for repotrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC).
By Zai Lab Limited · Via GlobeNewswire · June 28, 2023
Zai Lab and Novocure Announce LUNAR Phase 3 Clinical Trial Demonstrates Statistically Significant and Clinically Meaningful Extension in Overall Survival for Patients with Metastatic Non-Small Cell Lung Cancer After Platinum-Based Therapies
Tumor Treating Fields therapy together with standard of care provided a statistically significant and clinically meaningful 3-month improvement in median overall survival versus standard of care with no added systemic toxicities
By Zai Lab Limited · Via GlobeNewswire · June 6, 2023
Zai Lab to Highlight New Data from its Oncology Pipeline at 2023 ASCO Annual Meeting
Three poster presentations to provide updates on Zai Lab’s oncology programs focused on unresectable solid tumors, ovarian cancer and gastrointestinal stromal tumors
By Zai Lab Limited · Via GlobeNewswire · June 1, 2023
Zai Lab Announces Participation in June Investor Conferences
SHANGHAI, China and CAMBRIDGE, Mass., May 25, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that members of the company’s senior management team will participate in the following investor conferences in June 2023:
By Zai Lab Limited · Via GlobeNewswire · May 25, 2023
Zai Lab Announces That Repotrectinib Granted Priority Review by China’s NMPA
SHANGHAI, China and CAMBRIDGE, Mass., May 18, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted priority review to repotrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC).
By Zai Lab Limited · Via GlobeNewswire · May 18, 2023
Zai Lab Announces First Quarter 2023 Financial Results and Corporate Updates
SHANGHAI and CAMBRIDGE, Mass., May 09, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced financial results for the first quarter of 2023, along with recent product highlights and corporate updates.
By Zai Lab Limited · Via GlobeNewswire · May 9, 2023
Zai Lab Announces Strategic Partnership and Global License Agreement with MediLink Therapeutics for a Next Generation Antibody-Drug Conjugate Program in Oncology
YL212 expands Zai Lab’s lung cancer franchise and enriches its global oncology pipeline with a potential first-in-class ADC
By Zai Lab Limited · Via GlobeNewswire · April 27, 2023
Zai Lab Announces Presentation of Results of the LUNAR Phase 3 Clinical Trial in Non-Small Cell Lung Cancer at 2023 American Society of Clinical Oncology (ASCO) Annual Meeting
SHANGHAI and CAMBRIDGE, Mass., April 26, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (Nasdaq: ZLAB; HKEX: 9688) today announced that the results of the LUNAR phase 3 clinical trial in metastatic, non-small cell lung cancer (NSCLC) will be presented for the first time at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, to be held from June 2 to June 6.
By Zai Lab Limited · Via GlobeNewswire · April 26, 2023
Zai Lab to Announce First Quarter 2023 Financial Results and Corporate Updates on May 9, 2023
Company to Host Conference Call and Webcast on May 10, 2023, at 8:00 a.m. ET
By Zai Lab Limited · Via GlobeNewswire · April 20, 2023
Zai Lab to Highlight New Data from its Oncology Portfolio at 2023 AACR Annual Meeting
New translational and clinical biomarker data from Zai Lab’s global oncology program ZL-1211 will be featured in a poster presentation (Abstract presentation number: 4531)
By Zai Lab Limited · Via GlobeNewswire · April 11, 2023
Zai Lab Partner Karuna Therapeutics Announces Positive Results from Phase 3 EMERGENT-3 Trial of KarXT in Schizophrenia
Third positive registrational trial met its primary endpoint, with KarXT demonstrating an 8.4-point reduction in PANSS total score compared to placebo at Week 5 (p<0.0001)
By Zai Lab Limited · Via GlobeNewswire · March 20, 2023
Zai Lab Announces Full-Year 2022 Financial Results and Recent Corporate Updates
SHANGHAI and CAMBRIDGE, Mass., March 01, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced full-year 2022 financial results, along with recent product highlights and corporate updates.
By Zai Lab Limited · Via GlobeNewswire · March 1, 2023
Zai Lab Announces Participation in March Investor Conferences
SHANGHAI and CAMBRIDGE, Mass., Feb. 28, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), today announced that members of the company’s senior management team will participate in the following investor conferences in March 2023:
By Zai Lab Limited · Via GlobeNewswire · February 28, 2023
Zai Lab to Present Two New Phase 3 Analyses for Niraparib in Ovarian Cancer at the 2023 ESMO Gynaecological Cancers Congress
SHANGHAI, China and CAMBRIDGE, Mass., Feb. 22, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) will present two oral presentations highlighting the ad hoc interim overall survival (OS) study results of ZEJULA® (niraparib) from the NORA Phase 3 study and a post hoc analysis from the Phase 3 PRIME trial of niraparib maintenance therapy at the upcoming European Society for Medical Oncology (ESMO) Gynaecological Cancers Congress on February 23-24, 2023.
By Zai Lab Limited · Via GlobeNewswire · February 22, 2023
Zai Lab Announces NDA Acceptance of Sulbactam-Durlobactam (SUL-DUR) for Infections Caused by Acinetobacter baumannii in China by the NMPA
SHANGHAI and CAMBRIDGE, Mass., Feb. 22, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the National Medical Products Administration (NMPA) in China has accepted the New Drug Application (NDA) for sulbactam-durlobactam (SUL-DUR), an investigational drug that combines sulbactam, a β-lactam antibiotic, and durlobactam, a novel broad-spectrum β-lactamase inhibitor for the treatment of infections caused by Acinetobacter baumannii, including multidrug-resistant and carbapenem-resistant (CRAB) strains.
By Zai Lab Limited · Via GlobeNewswire · February 22, 2023