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Zai Lab Limited (ZLAB) is a global biopharmaceutical innovator developing therapies for oncology, autoimmune disorders, and infectious diseases. This news hub provides verified updates on clinical advancements, regulatory milestones, and strategic partnerships critical to investors and healthcare professionals.
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Zai Lab (NASDAQ: ZLAB) announced positive Phase 3 results for bemarituzumab in treating FGFR2b-positive first-line gastric cancer. The FORTITUDE-101 clinical trial demonstrated that bemarituzumab plus chemotherapy achieved a statistically significant and clinically meaningful improvement in overall survival compared to placebo plus chemotherapy in patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction cancer.
The study focused on patients with FGFR2b overexpression (defined as 2+/3+ staining in ≥10% of tumor cells) who are non-HER2 positive. Bemarituzumab is the first FGFR2b inhibitor to show significant overall survival benefit in a Phase 3 trial for first-line treatment of FGFR2b-positive gastric cancer.
The most common adverse events included reduced visual acuity, punctate keratitis, anemia, neutropenia, nausea, corneal epithelium defect, and dry eye. Ocular events occurred with greater frequency and severity in the bemarituzumab arm. The company plans to pursue regulatory submission in China, where the drug has already received Breakthrough Therapy designation.
Zai Lab (NASDAQ: ZLAB) has received Fast Track designation from the FDA for ZL-1310, its DLL3-targeted antibody-drug conjugate (ADC) for treating extensive-stage small cell lung cancer (ES-SCLC). The drug previously received Orphan Drug designation for SCLC. The company plans to initiate a pivotal study in 2025, aiming for potential accelerated approval by 2027.
The Fast Track status enables more frequent FDA interactions and eligibility for Accelerated Approval and Priority Review. Zai Lab will present updated data at the 2025 ASCO Annual Meeting and host an investor conference call on June 2, 2025, to discuss clinical development plans.
Zai Lab (NASDAQ: ZLAB) will present data on two internally developed oncology therapies at AACR 2025. The first, ZL-6201, is a potential first-in-class antibody-drug conjugate (ADC) targeting LRRC15-positive solid tumors, with plans to begin IND-enabling studies in 2025. Preclinical studies show ZL-6201 effectively suppresses tumor growth and demonstrates efficient internalization within tumor cells.
The second therapy, ZL-1222, is a novel anti-PD-1/interleukin-12 immunocytokine designed to improve upon current IL-12 treatments by reducing systemic toxicity while maintaining anti-tumor activity. Preclinical data indicates potent anti-tumor activity in both anti-PD-1 sensitive and resistant tumor models with improved safety profiles.
Both therapies showcase Zai Lab's commitment to developing innovative oncology treatments that address limitations of first-generation therapies, particularly in delivering higher concentrations of cytotoxic agents while limiting off-target toxicity.
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) announced it will present updated data from its ongoing global Phase 1a/1b clinical trial (NCT06179069) for ZL-1310, a potential first-in-class DLL3-targeted antibody-drug conjugate (ADC), at the 2025 ASCO Annual Meeting. The trial focuses on patients with extensive-stage small cell lung cancer (ES-SCLC) who have received at least one prior platinum-based chemotherapy regimen.
The data presentation will take place during a poster session on June 2, 2025, at McCormick Place Convention Center. Dr. Manish R. Patel from Florida Cancer Specialists/Sarah Cannon Research Institute will present the findings. The company will also host an investor conference call and webcast on the same day to discuss the data and outline future clinical development plans.
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) announced that China's National Medical Products Administration (NMPA) has accepted their supplemental New Drug Application (sNDA) for repotrectinib. The drug is intended to treat adult patients with solid tumors containing neurotrophic tyrosine receptor kinase (NTRK) gene fusion, specifically for cases where the disease is locally advanced or metastatic, or where surgery could cause severe morbidity.
The treatment targets patients who have either progressed after prior therapies or lack satisfactory alternative treatments. Notably, there are currently no approved treatments in China for NTRK-positive cancers for both TKI-naïve and TKI-pretreated patients. The NMPA previously granted priority review to repotrectinib in February 2025 for treating adult patients with advanced solid tumors having NTRK gene fusion.