The approval is based on the pivotal TRIDENT-1 trial, in which AUGTYRO achieved a high response rate and durable responses, including robust intracranial responses SHANGHAI & CAMBRIDGE, Mass. / May 12, 2024 / 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... Read More

Net product revenue of $87.1 million for the first quarter of 2024, representing 39% y-o-y growth; 43% y-o-y growth at constant exchange rate (CER) VYVGART ® (efgartigimod alfa injection) sales of $13.2 million for the first quarter of 2024, driven by increased patient access; an estimated 2,700 new patients were treated with VYVGART in the first quarter of 2024 Regulatory reviews ongoing for sulbactam-durlobactam for ABC,... Read More

Company to Host Conference Call and Webcast on May 9, 2024, at 8:00 a.m. ET (8:00 p.m. HKT) SHANGHAI & CAMBRIDGE, Mass. / Apr 15, 2024 / 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... Read More

SHANGHAI & CAMBRIDGE, Mass. / Apr 11, 2024 / 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... Read More

Poster sessions to highlight Phase 1 trials of internal oncology candidates ZL-1310, a next-generation antibody-drug conjugate for small cell lung cancer and other DLL3+ solid tumors, and ZL-1218, an anti-CCR8 antibody for advanced solid tumors These internally discovered programs underscore the Company’s focus on extending oncology R&D innovation to people with cancer worldwide SHANGHAI & CAMBRIDGE, Mass. / Apr 02, 2024 /... Read More

SHANGHAI & CAMBRIDGE, Mass. / Apr 01, 2024 / Business Wire / 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 monotherapy in patients with pretreated locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring a KRAS G12C mutation, met the primary endpoint of progression-free survival (PFS)... Read More

The METIS trial demonstrated 21.9 months median time to intracranial progression for patients treated with Tumor Treating Fields and supportive care compared to 11.3 months for patients treated with supportive care alone SHANGHAI & CAMBRIDGE, Mass. / Mar 27, 2024 / Business Wire / Zai Lab Limited (Nasdaq: ZLAB; HKEX: 9688) partner Novocure (NASDAQ: NVCR) today announced the phase 3 METIS clinical trial met its primary... Read More

ZL-1310 is an innovative ADC targeting DLL3, a promising therapeutic target in small cell lung cancer and other DLL3 + solid tumors Data will be shared in a poster presentation at the European Lung Cancer Congress 2024 (ELCC 2024) SHANGHAI & CAMBRIDGE, Mass. / Mar 13, 2024 / Business Wire / Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that it will present findings from preclinical studies highlighting the... Read More

Findings will be shared in oral presentations at the 2024 Congress of the European Society of Gynaecological Oncology (ESGO) and the 2024 Society for Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer SHANGHAI & CAMBRIDGE, Mass. / Mar 06, 2024 / 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,... Read More

SHANGHAI & CAMBRIDGE, Mass. / Mar 06, 2024 / 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... Read More

Total product revenue of $266.7 million for Full-Year 2023, representing 25% y-o-y growth; 31% y-o-y growth at constant exchange rate (CER) VYVGART ® (efgartigimod alfa injection) was launched in September 2023 in China and we estimate that nearly 1,000 patients were treated through the fourth quarter before its listing on China’s National Reimbursement Drug List (NRDL) We estimate that nearly 1,000 new patients were treated... Read More

Company to Host Conference Call and Webcast on February 28, 2024, at 8:00 a.m. ET (9:00 p.m. HKT) SHANGHAI & CAMBRIDGE, Mass. / Jan 25, 2024 / Business Wire / 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... Read More

Phase 1/2 TRIDENT-1 study data demonstrate repotrectinib’s clinically meaningful response rates and durable clinical activity in patients with ROS1-positive non-small cell lung cancer Data show robust intracranial activity both in TKI naïve and pretreated settings in patients with ROS1-positive NSCLC Findings demonstrate potential of repotrectinib to overcome limitations of first-generation TKIs in terms of durability of... Read More

SHANGHAI & CAMBRIDGE, Mass. / Dec 19, 2023 / 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 January 2024: J.P. Morgan 42nd Annual Healthcare Conference Presentation: Monday, January 8, 2024, 3:45 p.m. PST Location: San Francisco A live webcast of the presentation will be available on the... Read More

BOSTON, Dec. 13, 2023 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. , a biopharmaceutical company focused on the development and commercialization of innovative therapies for life-threatening diseases and other public health threats, today announced that China’s National Healthcare Security Administration (NHSA) has added the oral formulation of NUZYRA® (omadacycline) to the country’s National Reimbursement Drug List... Read More

SHANGHAI & CAMBRIDGE, Mass. / Dec 12, 2023 / Business Wire / 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: VYVGART ® (efgartigimod alfa injection) is included for the first time in the NRDL for the treatment of adult... Read More

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... Read More

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: Jefferies London Healthcare Conference Fireside Chat: Wednesday, November 15 th at 1:00 p.m. GMT Location: London 6th Annual Evercore ISI HealthCONx Conference Fireside... Read More

SHANGHAI, China and CAMBRIDGE, Mass., Oct. 18, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that it will report financial results for the third quarter of 2023 and recent corporate updates, after the closing of the U.S. equity markets on November 7, 2023. The Company will host a live conference call and webcast on November 8, 2023, at 8:00 a.m. ET. Conference Call and Webcast... Read More

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... Read More

SHANGHAI, China and CAMBRIDGE, Mass., Aug. 30, 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 investigational repotrectinib for the treatment of patients with advanced solid tumors that have an NTRK gene fusion who have progressed following... Read More

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: Citi's 18th Annual BioPharma Conference Panel Discussion: Wednesday, September 6 th at 10:30 a.m. ET Location: Boston 2023 Cantor Global Healthcare Conference Fireside... Read More

Total product revenue of $68.9 million for the second quarter of 2023, representing 45% y-o-y growth; 53% y-o-y growth at constant exchange rate VYVGART ® (efgartigimod alfa injection) approved in China as first-and-only neonatal Fc receptor (FcRn) blocker for generalized myasthenia gravis (gMG); preparations for launch underway; subcutaneous efgartigimod for gMG under Biologics License Application (BLA) review Primary... Read More

SHANGHAI, China and CAMBRIDGE, Mass., July 20, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that it will report financial results for the second quarter of 2023 and recent corporate updates, after the closing of the U.S. equity markets on August 7, 2023. The Company will host a live conference call and webcast on August 8, 2023, at 8:00 a.m. ET. Conference Call and Webcast Information... Read More

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 SHANGHAI, China and CAMBRIDGE, Mass., July... Read More

Study met primary endpoint (p=0.000039); VYVGART ® Hytrulo demonstrated 61% reduction (HR: 0.39 95% CI: 0.25; 0.61) in risk of relapse versus place IgG autoantibodies shown to play significant role in underlying CIDP disease biology Favorable safety and tolerability profile consistent with previous clinical trials and confirmed safety profile of VYVGART ® Zai Lab enrolled a significant number of patients in the Greater China... Read More

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... Read More

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). “We are pleased to... Read More

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... Read More

First-and-only approved FcRn antagonist for gMG patients by NMPA 68% of anti-AChR antibody positive gMG patients treated with VYVGART were responders (n=44/65) on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale compared with 30% of patients treated with placebo (n=19/64) (p<0.0001) during the first treatment cycle in the Phase 3 ADAPT trial Zai Lab to seek National Reimbursement Drug List (NRDL) inclusion for... Read More

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). “We are pleased to obtain the NMPA’s... Read More

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 Tumor Treating Fields therapy together with immune checkpoint inhibitors resulted in an unprecedented 8-month improvement in median overall survival LUNAR is the first phase 3 clinical trial in more... Read More

Three poster presentations to provide updates on Zai Lab’s oncology programs focused on unresectable solid tumors, ovarian cancer and gastrointestinal stromal tumors Early Phase 1/2 study data from Zai Lab’s internally developed ZL-1211 program support a solid safety/tolerability profile and preliminary antitumor activity SHANGHAI, China and CAMBRIDGE, Mass., June 01, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB;... Read More

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: Jefferies Global Healthcare Conference Fireside Chat: Friday, June 9, 2023, 10:30 a.m. ET Location: New York Goldman Sachs 44th Annual Global Healthcare Conference Fireside... Read More

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). “The CDE’s decision to grant... Read More

Total product revenue of $62.8 million for the first quarter of 2023, representing a 36% increase y-o-y; ZEJULA® achieved 44% y-o-y growth Expansion of Zai Lab’s lung cancer franchise and global oncology pipeline with a next generation antibody-drug conjugate (ADC) program Strong balance sheet with a cash position of $931.4 million as of March 31, 2023, compared to $1,009.3 million as of December 31, 2022 Company to host... Read More

SHANGHAI, China and CAMBRIDGE, Mass., April 27, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced a strategic partnership and exclusive worldwide license agreement with MediLink Therapeutics (MediLink). MediLink is an innovative drug development company focusing on next generation anti-body-drug conjugates (ADCs) and related technologies. Through this collaboration, we have expanded our lung... Read More

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. Our partner NovoCure Limited (Novocure) is... Read More

SHANGHAI, China and CAMBRIDGE, Mass., April 20, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that it will report financial results for the first quarter of 2023 and recent corporate updates after the closing of the U.S. equity markets on May 9, 2023. The Company will host a live conference call and webcast on May 10, 2023, at 8:00 a.m. ET. Conference Call and Webcast Information... Read More

SHANGHAI and CAMBRIDGE, Mass., April 11, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) will present new data including a translational and biomarker data analysis from its internal oncology discovery program ZL-1211 at the upcoming 2023 American Association for Cancer Research (AACR) Annual Meeting in Orlando on April 14-19, 2023. ZL-1211 is an anti-CLDN18.2 antibody currently in a Phase 1 clinical... Read More

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) KarXT was generally well tolerated, with a side effect profile substantially consistent with previous trials of KarXT in schizophrenia Karuna is on track to submit a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) in mid-2023, with... Read More

Total revenue of $215.0 million for 2022, representing a 49.0% increase y-o-y; ZEJULA ® achieved 55.2% y-o-y growth Strong balance sheet with a cash position of $1.0 billion as of December 31, 2022 Company to host conference call and webcast on March 2, 2023, at 8:00 a.m. EST SHANGHAI and CAMBRIDGE, Mass., March 01, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced full-year 2022 financial... Read More

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: Jefferies 2023 Biotech on the Bay Summit Panel Discussion: Thursday, March 16, 2023, 12:15 p.m. ET Location: Miami 26th Credit Suisse Asian Investment Conference Date: Monday,... Read More

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)... Read More

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... Read More

SHANGHAI and CAMBRIDGE, Mass., Feb. 09, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), today announced that it will report financial results and corporate updates for the twelve months ended December 31, 2022, after the closing of the U.S. equity markets on March 1, 2023. The Company will host a live conference call and webcast on March 2, 2023, at 8:00 a.m. ET. Conference Call and Webcast Information... Read More

SHANGHAI and CAMBRIDGE, Mass., Jan. 31, 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 February 2023: Guggenheim Oncology Conference Fireside Chat: Wednesday, February 8, 2023, 3:20 p.m. EST Location: New York SVB Securities Global Biopharma Conference Fireside Chat: Tuesday,... Read More

SHANGHAI and CAMBRIDGE, Mass., Jan. 30, 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 status to the New Drug Application (NDA) for sulbactam-durlobactam (SUL-DUR) for the treatment of infections caused by Acinetobacter baumannii, including multidrug-resistant... Read More

SHANGHAI and CAMBRIDGE, Mass., Jan. 18, 2023 (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 both QINLOCK ® (ripretinib) for advanced gastrointestinal stromal tumor... Read More

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... Read More

The LUNAR study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in overall survival The full LUNAR data will be presented at a future medical congress SHANGHAI and CAMBRIDGE, Mass. and ROOT, Switzerland, Jan. 05, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (Nasdaq: ZLAB; HKEX: 9688) and Novocure (NASDAQ: NVCR) today announced the LUNAR study met its primary endpoint,... Read More

SHANGHAI and CAMBRIDGE, Mass., Jan. 03, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) a patient-focused, innovative, commercial-stage, global biopharmaceutical company, today announced the appointment of Rafael G. Amado, M.D. as President, Head of Global Oncology Research and Development, effective December 30, 2022. Dr. Amado brings to Zai Lab deep expertise in the field of oncology and significant... Read More

SHANGHAI, China and CAMBRIDGE, Mass., Dec. 20, 2022 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), a patient-focused, innovative, commercial-stage, global biopharmaceutical company, today announced that senior management from Zai Lab will participate in the following investor conferences in January 2023: Morgan Stanley Virtual China Opportunity Conference Meetings: Wednesday, January 4, 2023 - Friday,... Read More

Median overall survival (mOS) was numerically longer for patients receiving ZEJULA regardless of biomarker status, at 46.3 months compared to 43.4 months in the placebo group No new safety issues were identified SHANGHAI, China and CAMBRIDGE, Mass., Dec. 15, 2022 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), a patient-focused, innovative, commercial-stage, global biopharmaceutical company, today presented... Read More