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, SAN FRANCISCO, and CAMBRIDGE, Mass., Jan. 12, 2022 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), a patient-focused, innovative, commercial-stage, global biopharmaceutical company, today announced treatment of the first patient in Greater China in the PANOVA-3 trial, a Phase 3 pivotal trial of Tumor Treating Fields in patients with pancreatic cancer.

Zai Lab Announces First Patient Treated in Greater China in PANOVA-3 Phase 3 Pivotal Trial of Tumor Treating Fields in Pancreatic Cancer

SHANGHAI and SAN FRANCISCO and CAMBRIDGE, Mass., Jan. 06, 2022 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), a patient-focused, innovative, commercial-stage, global biopharmaceutical company, today announced that the China National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for margetuximab, an investigational, Fc-engineered monoclonal antibody that targets HER2. The margetuximab NDA is for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease, in combination with chemotherapy.

Zai Lab Announces NDA Acceptance of Margetuximab for Patients with Pretreated Metastatic HER2-Positive Breast Cancer in China by the NMPA

SHANGHAI, SAN FRANCISCO and CAMBRIDGE, Mass., Dec. 29, 2021 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), a patient-focused, innovative, commercial-stage, global biopharmaceutical company, today announced that management from Zai Lab will be presenting at the following virtual investor conferences in January:

Zai Lab Announces Upcoming Presentations at January Investor Conferences

SHANGHAI and SAN FRANCISCO and CAMBRIDGE, Mass., Dec. 22, 2021 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), a patient-focused, innovative, commercial-stage, global biopharmaceutical company, today announced the promotion of Harald Reinhart, M.D., from his current role as Chief Medical Officer (CMO) to President and Head of Global Development for Neuroscience, Autoimmune and Infectious Diseases. Dr. Reinhart has been with the company since inception, first as an advisor and since 2017, as Chief Medical Officer responsible for the autoimmune and infectious diseases portfolio.

Zai Lab Announces Promotion of Harald Reinhart, M.D. to President and Head of Global Development, Neuroscience, Autoimmune and Infectious Diseases

SHANGHAI and SAN FRANCISCO and CAMBRIDGE, Mass., Dec. 17, 2021 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), a patient-focused, innovative, commercial-stage, global biopharmaceutical company, today announced that its partner argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, today announced that the U.S. Food and Drug Administration (FDA) has approved VYVGART™ (efgartigimod alfa-fcab) for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. These patients represent approximately 85% of the total gMG population1. With this regulatory milestone, VYVGART is the first and only FDA-approved neonatal Fc receptor (FcRn) blocker.

Zai Lab Partner argenx Announces U.S. Food and Drug Administration (FDA) Approval of VYVGART™ (efgartigimod alfa-fcab) in Generalized Myasthenia Gravis

The China National Medical Products Administration (NMPA) has approved Zai Lab Limited's (NASDAQ: ZLAB) Nuzyra (omadacycline), a novel antibiotic with both oral and intravenous (IV) formulations. The approval covers the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).

Zai Lab's Nuzyra Approved In China For Bacterial Infections

The stock price of Zai Lab Ltd (NASDAQ: ZLAB) increased by over 3% pre-market today. This is why it happened.

Zai Lab Stock (ZLAB): Why The Price Increased Today

NUZYRA demonstrated efficacy against common pathogens in three Phase 3 studies, including pathogens resistant to other antibiotic classes as a potential best-in-class tetracycline

China NMPA Approves NUZYRA® as a Category 1 Innovative Drug for the Treatment of Patients with Community-Acquired Bacterial Pneumonia (CABP) and Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

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SHANGHAI, SAN FRANCISCO, and CAMBRIDGE, Mass., Dec. 03, 2021 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), a patient-focused, innovative, commercial-stage, global biopharmaceutical company, today announced that the National Reimbursement Drug List (NRDL) released by China's National Healthcare Security Administration (NHSA) has been updated to include ZEJULA (niraparib) as a first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer (collectively termed as ovarian cancer) following a response to platinum-based chemotherapy, regardless of biomarker status.

Zai Lab Announces Inclusion of ZEJULA® (Niraparib) in China's National Reimbursement Drug List for First-Line Ovarian Cancer

The stock price of Zai Lab Ltd (NASDAQ: ZLAB) increased by over 2% during intraday trading today. This is why it happened.

Zai Lab (ZLAB) Stock: Why The Priced Increased Today

•   PRIME study demonstrates that niraparib treatment had a clinically meaningful and statistically significant benefit in improving progression-free survival in the overall study population regardless of biomarker status when compared to placebo

Zai Lab Announces Positive Topline Results from Phase 3 PRIME Study of ZEJULA® (Niraparib) as First-Line Monotherapy Maintenance Treatment in Chinese Women with Platinum-Responsive Advanced Ovarian Cancer

SHANGHAI, SAN FRANCISCO and CAMBRIDGE, Mass., Nov. 23, 2021 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), a patient-focused, innovative, commercial-stage, global biopharmaceutical company, today announced that management from Zai Lab will be presenting at the following virtual investor conferences in December:

Zai Lab Announces Upcoming Presentations at December Investor Conferences

SHANGHAI and SAN FRANCISCO and CAMBRIDGE, Mass., Nov. 22, 2021 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), a patient-focused, innovative, commercial-stage, global biopharmaceutical company, announced today that it has appointed Richard Gaynor, M.D., to its Board of Directors. Dr. Gaynor will also serve as Chair of the Research and Development Committee.

Zai Lab Appoints Richard Gaynor, MD, to its Board of Directors

SHANGHAI and SAN FRANCISCO and CAMBRIDGE, Mass., Nov. 16, 2021 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), a patient-focused, innovative, commercial-stage, global biopharmaceutical company, today announced that the first patient has been dosed in the Greater China portion of the global registrational ADHERE study of efgartigimod in patients with chronic inflammatory demyelinating polyneuropathy (CIDP).

Zai Lab Announces First Patient Dosed in Greater China in Global Registrational Clinical Trial of Efgartigimod in CIDP

SHANGHAI and SAN FRANCISCO and CAMBRIDGE, Mass., Nov. 11, 2021 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), is a patient-focused, innovative, commercial-stage, global biopharmaceutical company. The company announced today that the first patient with primary immune thrombocytopenia (ITP) was treated with efgartigimod in Greater China (mainland China, Hong Kong, Macau, and Taiwan) as part of the global registrational ADVANCE-SC Phase 3 study. The ADVANCE-SC study is a randomized, double-blind, placebo-controlled, multi-center Phase 3 trial evaluating the efficacy and safety of subcutaneous (SC) efgartigimod in approximately 156 adult patients with primary ITP.

Zai Lab Announces First Patient Dosed in Greater China in Global Registrational Clinical Trial of Efgartigimod in Primary Immune Thrombocytopenia

Zai Lab Limited (ZLAB) CEO Samantha Du on Q3 2021 Results - Earnings Call Transcript

-- Broad Product Pipeline Expands Both Vertically and Horizontally with Three New Potential First-in-Class or Best-in-Class Medicines

Zai Lab Announces Third Quarter 2021 Financial Results and Corporate Updates

Zai Lab Limited (NASDAQ: ZLAB) and Blueprint Medicines Corporation (NASDAQ: BPMC) have announced an exclusive collaboration and license agreement in Greater China, including mainland China, Hong Kong, Macau, and Taiwan. The agreement covers the development and commercialization of BLU-945 and BLU-701 for epidermal growth factor receptor (EGFR)-driven non-small cell lung cancer.

Zai Lab Inks Back To Back Licensing Agreements For Cancer And Psychiatric Candidates

Blueprint Medicines

CAMBRIDGE, Mass. and SHANGHAI and SAN FRANCISCO, Nov. 9, 2021 /PRNewswire/ -- Blueprint Medicines Corporation (NASDAQ: BPMC) and Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced an exclusive collaboration and license agreement for the development and commercialization of BLU-945 and BLU-701 for the treatment of patients with epidermal growth factor receptor (EGFR) -driven non-small cell lung cancer (NSCLC) in Greater China, including mainland China, Hong Kong, Macau and Taiwan.

Blueprint Medicines and Zai Lab Announce Strategic Collaboration and License Agreement for BLU-945 and BLU-701 in Greater China

Zai Lab obtains exclusive rights to develop and commercialize KarXT in Greater China

Zai Lab and Karuna Therapeutics Announce Strategic Collaboration for Development, Manufacturing, and Commercialization of KarXT in Greater China

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BOSTON & SHANGHAI & SAN FRANCISCO--(BUSINESS WIRE)---- $KRTX--Karuna Therapeutics, Inc. (NASDAQ: KRTX), a clinical-stage biopharmaceutical company driven to create and deliver transformative medicines for people living with psychiatric and neurological conditions, and Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), a patient-focused, innovative, commercial-stage, global biopharmaceutical company, today announced their entry into an exclusive license agreement for the development, manufacturing, and commercia

Karuna Therapeutics and Zai Lab Announce Strategic Collaboration for Development, Manufacturing, and Commercialization of KarXT in Greater China

The world-wide Covid-19 experience makes clear the international nature of healthcare protection, aggravated by 21st century advances on 20th century air travel and business globalization. China has become a pivotal figure in dealing with widespread pandemics. The nature of health as a potential warfare dimension raises national security issues.

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