At an Interim Analysis, Bemarituzumab Plus Chemotherapy Significantly Improved Overall Survival in People With FGFR2b Overexpression Compared to Chemotherapy Alone SHANGHAI & CAMBRIDGE, Mass. / Jun 30, 2025 / Business Wire / Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced the Phase 3 FORTITUDE-101 clinical trial evaluating first-line bemarituzumab plus chemotherapy (mFOLFOX6) met its primary endpoint of overall... Read More

Data highlights potential of ZL-1503 as a promising treatment for moderate-to-severe atopic dermatitis and other IL-13 and IL-31-driven diseases Favorable preclinical safety profile, prolonged half-life and durable suppression of both inflammatory and pruritogenic pathways support advancement of ZL-1503 to IND-enabling studies Zai Lab plans to file an IND for ZL-1503 for moderate-to-severe atopic dermatitis by the end of... Read More

Clinically meaningful anti-tumor activity of ZL-1310 observed in heavily pretreated population of patients with small cell lung cancer (SCLC) across dose escalation and expansion cohorts In second-line (2L) SCLC, objective response rate (ORR) was 67% across all dose levels (n=33) and 79% at 1.6 mg/kg dose (n=14) Median duration of response has not yet been reached, with 29 of 38 responders remaining on study; 27 of 31... Read More

TTFields therapy concomitant with gemcitabine and nab-paclitaxel is the first treatment to show a clinically meaningful and statistically significant improvement in overall survival (OS) for patients with unresectable, locally advanced pancreatic adenocarcinoma in a Phase 3 trial The OS benefit observed with TTFields therapy is supported by significantly improved quality of life and extended pain-free survival, a key outcome... Read More

SHANGHAI & CAMBRIDGE, Mass. / May 30, 2025 / 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 June 2025: Jefferies Global Healthcare Conference Fireside Chat: Wednesday, June 4, 2025, 10:30 a.m. EST Webcast Link: https://wsw.com/webcast/jeff319/zlab/1845848 Location: New York, NY Goldman... Read More

The Company is on track to initiate a pivotal study for ZL-1310 in small cell lung cancer (SCLC) in 2025 SHANGHAI & CAMBRIDGE, Mass. / May 19, 2025 / Business Wire / Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ZL-1310, the Company’s potential first-in-class Delta-like ligand (DLL3) antibody-drug conjugate (ADC), for the treatment... Read More

Total revenues grew 22% y-o-y to $106.5 million for the first quarter of 2025; reaffirming full-year 2025 revenue guidance of $560 million to $590 million Operating loss improved significantly, declining 20% year-over-year to $56.3 million for the first quarter of 2025, and 25% to $37.1 million on an adjusted basis 1 ; on track to achieve profitability 1 in the fourth quarter of 2025 ZL-1310 (DLL3 ADC) is advancing rapidly,... Read More

Findings support advancement of ZL-6201 into Investigational New Drug (IND)-enabling studies in 2025 as a potential first-in-class and best-in-class antibody-drug conjugate (ADC) treatment for patients with leucine-rich repeat-containing protein 15 (LRRC15)-positive solid tumors Data from preclinical studies suggest ZL-1222, a novel anti-PD-1/interleukin-12 (IL-12) immunocytokine, induces potent anti-tumor activity through... Read More

Zai Lab will highlight potential of ZL-1310 as a promising, best-in-class Delta-like ligand (DLL3-targeted) ADC for patients with extensive-stage small cell lung cancer (ES-SCLC) Investor conference call and webcast to discuss data and clinical trial plans on June 2, 2025, at 7:00 a.m. CT / 8:00 a.m. ET / 8:00 p.m. HKT SHANGHAI & CAMBRIDGE, Mass. / Apr 23, 2025 / Business Wire / Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688)... Read More

SHANGHAI & CAMBRIDGE, Mass. / Apr 21, 2025 / Business Wire / Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that China’s National Medical Products Administration (NMPA) has accepted the supplemental New Drug Application (sNDA) for repotrectinib for the treatment of adult patients with solid tumors that harbor a neurotrophic tyrosine receptor kinase ( NTRK ) gene fusion. The application is intended for patients... Read More

Company to host conference call and webcast on May 8, 2025, at 8:00 a.m. ET (8:00 p.m. HKT) SHANGHAI & CAMBRIDGE, Mass. / Apr 14, 2025 / Business Wire / Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that it will report its first quarter 2025 financial results and provide recent corporate updates on May 8, 2025, before the opening of the U.S. equity markets. The announcement will be followed by a conference call... Read More

Poster presentation will highlight the potential of ZL-6201 as an innovative antibody-drug conjugate (ADC) for the treatment of sarcoma and other leucine-rich repeat-containing protein 15 (LRRC15)-positive solid tumors Late-breaking poster presentation will summarize data from preclinical evaluation of ZL-1222, a promising next-generation interleukin-12 (IL-12) immunocytokine therapy for the treatment of various cancers... Read More

SHANGHAI & CAMBRIDGE, Mass. / Mar 12, 2025 / Business Wire / 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 TIVDAK (tisotumab vedotin-tftv) for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy. “In China, cervical cancer... Read More

SHANGHAI & CAMBRIDGE, Mass. / Mar 03, 2025 / 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 March 2025: Leerink Partners 2025 Global Healthcare Conference Fireside Chat: Monday, March 10, 2025, 9:20 a.m. EST Location: Miami, FL Jefferies Biotech on the Beach Summit Time: Tuesday, March... Read More

Total revenues grew 66% y-o-y to $109.1 million for the fourth quarter of 2024 and 50% y-o-y to $399.0 million for the full-year 2024; Full-year 2025 revenue guidance of $560 million to $590 million VYVGART ® and VYVGART Hytrulo ® sales reached $30.0 million for the fourth quarter of 2024 and $93.6 million for the full-year 2024 Loss from operations decreased 45% y-o-y to $67.9 million for the fourth quarter of 2024 and 23%... Read More

Company to host conference call and webcast on February 27, at 8:00 a.m. ET (9:00 p.m. HKT) SHANGHAI & CAMBRIDGE, Mass. / Jan 28, 2025 / Business Wire / 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... Read More

SHANGHAI & CAMBRIDGE, Mass. / Jan 22, 2025 / Business Wire / 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). “Receiving an Orphan Drug Designation for ZL-1310 recognizes its potential to... Read More

SHANGHAI & CAMBRIDGE, Mass. / Jan 17, 2025 / Business Wire / 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. “There are more than 8 million patients living with schizophrenia in China who face significant unmet needs due to the limited efficacy and... Read More

Improved overall survival (OS), progression-free survival (PFS) and confirmed objective response rate (ORR) were observed in the China subpopulation treated with TIVDAK compared to chemotherapy, consistent with those in the global population The safety profile of TIVDAK among the China subpopulation was manageable and consistent with that observed in the global population Zai Lab intends to submit a New Drug Application... Read More

Exclusive collaboration and licensing agreement for povetacicept in the region Zai Lab will leverage its local expertise and commercial footprint to accelerate development of povetacicept and bring the medicine to eligible patients in the region if approved SHANGHAI & CAMBRIDGE, Mass. & BOSTON / Jan 10, 2025 / Business Wire / Zai Lab Limited (Nasdaq: ZLAB; HKEX: 9688) and Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX)... Read More

SHANGHAI & SUZHOU, China & CAMBRIDGE, Mass. / Jan 09, 2025 / Business Wire / 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.... Read More

SHANGHAI & CAMBRIDGE, Mass. / Dec 12, 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 January 2025: 43rd Annual J.P. Morgan Healthcare Conference Presentation: Tuesday, January 14, 2025, 1:30 p.m. PST Location: San Francisco A live webcast of the presentation will be available on the... Read More

PANOVA-3 met its primary endpoint with a statistically significant improvement in overall survival for patients with unresectable, locally advanced pancreatic adenocarcinoma treated in the first-line with TTFields concomitant with gemcitabine and nab-paclitaxel Novocure plans to file for regulatory approval in the U.S., EU, Japan and other key markets; Zai Lab plans to file for regulatory approval in China Full results from... Read More

SHANGHAI & CAMBRIDGE, Mass. / Nov 27, 2024 / Business Wire / 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: AUGTYRO ® (repotrectinib) is included in the NRDL for the treatment of adult patients with locally advanced or... Read More

SHANGHAI & CAMBRIDGE, Mass. / Nov 21, 2024 / Business Wire / Zai Lab (“Zai Lab”, NASDAQ: ZLAB; HKEX: 9688) and Pfizer (“Pfizer”, NYSE: PFE) announced today a strategic collaboration for the novel antibacterial drug XACDURO ® (sulbactam-durlobactam) in mainland China. Pfizer’s affiliated companies will be exclusively authorized to undertake and perform certain commercialization activities for XACDURO ® in mainland China.... Read More

SHANGHAI & CAMBRIDGE, Mass. / Nov 18, 2024 / Business Wire / 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... Read More

SHANGHAI & CAMBRIDGE, Mass. / Nov 14, 2024 / Business Wire / 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. The gross proceeds to Zai Lab from... Read More

SHANGHAI & CAMBRIDGE, Mass. / Nov 13, 2024 / Business Wire / 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... Read More

Strong growth in net product revenue of 47% y-o-y to reach $101.8 million for the third quarter of 2024 Positive China bridging study of KarXT in schizophrenia; expected regulatory submission in early 2025 Global Phase 1 data of ZL-1310 (DLL3 ADC) suggests best-in-class potential in extensive-stage SCLC Three product launches in mainland China expected by the end of 2024, and up to four potential regulatory submissions to... Read More

First and only NMPA-approved treatment for patients with CIDP in China Third approval for efgartigimod franchise in China demonstrating Zai Lab’s deep expertise developing innovative treatments across a broad range of diseases SHANGHAI & CAMBRIDGE, Mass. / Nov 11, 2024 / Business Wire / Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) and argenx (Euronext & Nasdaq: ARGX) today announced that China’s National Medical Products... Read More

KarXT demonstrated a statistically significant 9.2-point reduction in PANSS Total score from baseline at Week 5 compared to placebo (p=0.0014) Trial also met all secondary endpoints, demonstrating statistically significant reductions in positive and negative symptoms of schizophrenia, as measured by the PANSS positive subscale, PANSS negative subscale and PANSS negative Marder factor score KarXT has a tolerable safety... Read More

Objective response rate (ORR) of 74% across all tested dose levels of ZL-1310 in patients with recurrent extensive-stage small cell lung cancer (SCLC) Favorable pharmacokinetics (PK) and safety profile support continued evaluation of ZL-1310 as a single agent and in combination for the treatment of extensive-stage SCLC in recurrent and first-line therapy Zai Lab to host conference call and webcast to discuss data on October... Read More

SHANGHAI & CAMBRIDGE, Mass. / Oct 18, 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 conferences in November and December 2024: Goldman Sachs APAC Healthcare Corporate Day 2024 Time: November 5-8, 2024 Location: Hong Kong, Hong Kong Jefferies London Healthcare Conference Fireside Chat: Tuesday,... Read More

Company to host conference call and webcast on October 24, 2024, at 8:30 a.m. ET (8:30 p.m. HKT), following plenary oral presentation of data at the EORTC-NCI-AACR Symposium (ENA) 2024 SHANGHAI & CAMBRIDGE, Mass. / Oct 17, 2024 / Business Wire / 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... Read More

Company to Host Conference Call and Webcast on November 12, 2024, at 8:00 a.m. ET (9:00 p.m. HKT) SHANGHAI & CAMBRIDGE, Mass. / Oct 16, 2024 / Business Wire / 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... Read More

Oral presentation during plenary session will discuss potential of ZL-1310 as an innovative ADC targeting Delta-like ligand 3 (DLL3), a validated therapeutic target in small cell lung cancer (SCLC) ZL-1310 is part of Zai Lab’s growing, internally developed global oncology pipeline SHANGHAI & CAMBRIDGE, Mass. / Oct 09, 2024 / Business Wire / Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688; “Zai Lab”) today announced that data from... Read More

Late-breaking oral presentation will discuss the potential of ZL-1503 as a novel treatment for moderate-to-severe atopic dermatitis and other diseases involving the IL-13 and IL-31 pathways ZL-1503 is part of Zai Lab’s internally discovered and developed global pipeline SHANGHAI & CAMBRIDGE, Mass. / Sep 17, 2024 / Business Wire / Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688; “Zai Lab”) today announced that data from a... Read More

Poster session will highlight potential of ZL-1218 to modulate tumor microenvironment and regulate anticancer immune response in advanced solid tumors Trial update demonstrates the advancement of company’s robust, internal global oncology pipeline SHANGHAI & CAMBRIDGE, Mass. / Aug 27, 2024 / Business Wire / Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that data from a Phase 1 study of ZL-1218, the company’s... Read More

SHANGHAI & CAMBRIDGE, Mass. / Aug 22, 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 conferences in September 2024: Morgan Stanley 22 nd Annual Global Healthcare Conference Location: New York, New York Cantor Fitzgerald Global Healthcare Conference Fireside Chat: Thursday, September 19, 2024,... Read More

Net product revenue of $100.1 million for the second quarter of 2024, representing 45% y-o-y growth; 47% y-o-y growth at constant exchange rate (CER) VYVGART ® (efgartigimod alfa injection) sales of $23.2 million for the second quarter of 2024; raising full-year VYVGART revenue guidance to exceed $80.0 million Expansion of Zai Lab’s global oncology pipeline with a next generation ROR1 antibody-drug conjugate (ADC) program... Read More

First and only NMPA-approved subcutaneous (SC) injectable providing additional flexibility and optionality for gMG patients in China Consistent clinical benefit and safety profile of efgartigimod SC compared to IV demonstrated in Phase 3 ADAPT-SC study SHANGHAI & CAMBRIDGE, Mass. / Jul 16, 2024 / Business Wire / Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) and argenx (Euronext & Nasdaq: ARGX) today announced that China’s... Read More

Manuscript represents the first publication from China’s gynecology oncology field to be published in Cell Publication highlights first-time learnings about the landscape of ovarian cancer microenvironment stratified by HRD and how a PARP inhibitor perturbs it Data suggest combination of niraparib and ZL-1218, an investigational CCR8 antibody, may decrease tumor burden, offering synergistic potential for improving efficacy... Read More

Company to Host Conference Call and Webcast on August 7, 2024, at 8:00 a.m. ET (8:00 p.m. HKT) SHANGHAI, China & CAMBRIDGE, Mass. / Jul 10, 2024 / 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... Read More

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

This is the first compound in Zai’s portfolio of internally developed drugs to advance into Phase 2, demonstrating Zai’s global capabilities Based on a proof-of-concept study, ZL-1102 is the first topical biologic to show penetration of psoriatic skin resulting in a clinical response SHANGHAI & CAMBRIDGE, Mass. / May 22, 2024 / Business Wire / Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the first patient... Read More

Drug-resistant Acinetobacter baumannii is a growing global health threat and high priority pathogen needing new antibiotics, according to World Health Organization China NMPA approval based on comprehensive clinical data demonstrating robust activity of SUL-DUR against carbapenem-resistant bacterial strains In China, it is estimated there are approximately 300,000 cases of Acinetobacter infections and approximately 74% of... Read More

sBLA submission based on positive results from the ADHERE trial, the first positive global neonatal FC receptor (FcRn) pivotal study for CIDP There are currently no approved therapies available in China for this serious autoimmune disease Milestone underscores Zai Lab’s operational capabilities and deep expertise developing and commercializing innovative treatments in China across a broad range of diseases SHANGHAI &... Read More

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