Zai Lab Ltd.

Zai Lab Ltd. is a biopharmaceutical company, which engages in the developing and commercializing therapies that address medical conditions with unmet needs in oncology, autoimmune disorders, infectious diseases, and neuroscience. Its products include Zejula, Optune, Qinlock, and Nuzyra. The company was founded by Samantha Ying Du and Marietta Wu in April 2014 and is headquartered in Shanghai, China.

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SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--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. “In the second quarter, we achieved impressive commercial growth, maintained financial discipline, and made significant strides across our product portfolio, highlighting our capability to execute on our strategic objectives,” said Dr. Samantha Du, Founder, Chairperson, and Chief Exe.

Zai Lab Announces Second Quarter 2024 Financial Results and Recent Corporate Updates

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SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--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.

Zai Lab and argenx Announce Approval of Efgartigimod Alfa Injection (Subcutaneous Injection) for Generalized Myasthenia Gravis in China

SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--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 n.

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

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SHANGHAI, China & CAMBRIDGE, Mass.--(BUSINESS WIRE)--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). Conference Call and Webcast Information Listeners may access the live webcast by visiting the C.

Zai Lab to Announce Second Quarter 2024 Financial Results and Recent Corporate Updates on August 6, 2024

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SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--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 resp.

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

SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--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 bein.

Zai Lab Initiates Global Phase 2 Clinical Trial Evaluating ZL-1102 As a Topical Treatment for Chronic Plaque Psoriasis

SHANGHAI & CAMBRIDGE, Mass. & WALTHAM, Mass.--(BUSINESS WIRE)--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 comp.

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

SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--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: J.P. Morgan 20th Annual Global China Summit Panel Discussion: Thursday, May 23, 2024, 10:00 a.m. HKT Location: Shanghai, China Jefferies Global Healthcare Conference Fireside Chat: Wednesday, June 5, 2024, 3:30 p.m. ET in Track 2 Location: New York, New York Goldm.

Zai Lab Announces Participation in May and June Investor Conferences

SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--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 Thera.

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

SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--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-.

Zai Lab Announces Approval of AUGTYRO™ (repotrectinib) for Patients with ROS1-positive NSCLC by China's NMPA

Zai Lab Limited (NASDAQ:ZLAB ) Q1 2024 Earnings Conference Call May 9, 2024 8:00 AM ET Company Participants Christine Chiou - Senior Vice President, Investor Relations Samantha Du - Founder, Chairperson & Chief Executive Officer Josh Smiley - President & Chief Operating Officer Rafael Amado - President & Head-Global Oncology Research & Development Harald Reinhart - President & Head-Global Development, Neuroscience, Autoimmune & Infectious Diseases Yajing Chen - Chief Financial Officer Jonathan Wang - Chief Business Officer Conference Call Participants Anupam Rama - JPMorgan Louise Chen - Cantor Michael Yee - Jefferies Linhai Zhao - Goldman Sachs Yigal Nochomovitz - Citigroup Jonathan Chang - Leerink Partners Jack Lin - Morgan Stanley Operator Hello, ladies and gentlemen, thank you for standing by and welcome to Zai Lab's First Quarter 2024 Financial Results Conference Call. At this time, all participants are in a listen-only mode.

Zai Lab Limited (ZLAB) Q1 2024 Earnings Call Transcript

SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--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. “Our first quarter results demonstrate strong commercial execution and pipeline progress across our potential first- and best-in-class product portfolio,” said Dr. Samantha Du, Founder, Chairperson, and Chief Executive Officer of Zai Lab. “The launch of VYVGART is off to an impressive.

Zai Lab Announces First Quarter 2024 Financial Results and Recent Corporate Updates

SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--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). Conference Call and Webcast Information Listeners may access the live webcast by visiting the Company's webs.

Zai Lab to Announce First Quarter 2024 Financial Results and Recent Corporate Updates on May 8, 2024

SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--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 o.

Zai Lab Statement on Executive Management Team's Agreement on Share Activities

SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--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. The global oncology programs to be showcased at AACR 2024 include a Phase 1a/1b study of ZL-1310 (NCT06179069), a novel antibody-drug c.

Zai Lab Presentations at AACR 2024 Annual Meeting to Showcase Ongoing Clinical Studies in Key Global Oncology Programs

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SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--  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 Non-Small Cell Lung Cancer   Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) partner Bristol Myers Squibb (NYSE: BMY) announced the pivotal Phase 3 KRYSTAL-12 study, evaluating KRAZATI® (adagrasib) as a monother.

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

Novocure

SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Zai Lab Limited (Nasdaq: ZLAB; HKEX: 9688) partner Novocure (NASDAQ: NVCR) 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 cance.

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

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SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--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. ZL-1310 is a novel a.

Zai Lab to Present Data Highlighting ZL-1310, a Novel Antibody-Drug Conjugate (ADC) for Treatment of Solid Tumors

SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--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 So.

Zai Lab to Present Final Overall Survival (OS) Data from Phase 3 NORA Study of ZEJULA (niraparib) in Platinum-Sensitive Recurrent Ovarian Cancer (PSROC)

SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--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: Leerink Partners Global Biopharma Conference 2024 Presentation: Monday, March 11, 2024, 4:00 p.m. ET Location: Fontainebleau, Miami Beach Room: Glimmer 3 A live webcast of the presentation will be available on the Investor Relations page of Zai Lab's website at ir.zailabo.

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