Zai Lab Limited Stock Price, News & Analysis

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.

Zai Lab (NASDAQ: ZLAB; HKEX: 9688) has scheduled the announcement of its first quarter 2025 financial results and corporate updates for May 8, 2025, before U.S. market opening. The company will host a conference call and webcast at 8:00 a.m. ET (8:00 p.m. HKT) on the same day.

Interested participants can access the live webcast through the company's investor relations website and must register in advance for the conference call through the provided registration links. A replay will be available on the company's website after the call.

Zai Lab (NASDAQ: ZLAB; HKEX: 9688) has announced the presentation of preclinical data for two internally developed cancer therapies at the AACR Annual Meeting 2025 in Chicago. The company will showcase:

1. ZL-6201: A novel antibody-drug conjugate (ADC) targeting LRRC15, which is overexpressed in various mesenchymal tumors including sarcoma, glioblastoma, and melanoma. This potential first-in-class treatment will be presented by Dr. Bing Wan on April 29, 2025.

2. ZL-1222: A next-generation PD-1-targeted IL-12 immunocytokine therapy designed to combine potent antitumor activity with improved systemic safety. Dr. Linda Liu will present this late-breaking research on April 28, 2025.

These developments align with Zai Lab's strategy for their internally developed global oncology pipeline, targeting multiple cancer types that remain challenging to treat with current standard-of-care therapies.

Zai Lab (NASDAQ: ZLAB) announced that China's NMPA has accepted the Biologics License Application (BLA) for TIVDAK to treat recurrent or metastatic cervical cancer patients whose disease progressed after systemic therapy.

The BLA is supported by the global Phase 3 innovaTV 301 trial and its China subpopulation results. In China, where approximately 150,000 new cervical cancer cases are diagnosed annually, TIVDAK demonstrated a 45% reduction in death risk compared to chemotherapy (HR: 0.55) in the China subpopulation. The median overall survival was not reached in the TIVDAK arm versus 10.7 months in the chemotherapy arm after 11.5 months median follow-up.

TIVDAK, the only antibody-drug conjugate therapy in cervical cancer, showed favorable results in secondary endpoints including progression-free survival and objective response rate, with manageable safety profile consistent with global data.