Welcome to our dedicated page for Zai Lab news (Ticker: ZLAB), a resource for investors and traders seeking the latest updates and insights on Zai Lab stock.
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; 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.
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) has announced its participation in two major investor conferences in March 2025. The company's senior management team will attend the Leerink Partners 2025 Global Healthcare Conference on March 10, featuring a fireside chat at 9:20 a.m. EST in Miami, FL. They will also participate in the Jefferies Biotech on the Beach Summit on March 11 in Miami, FL.
A live webcast of the fireside chat will be accessible through Zai Lab's Investor Relations website at ir.zailaboratory.com/webcasts-presentations, with archived replay available for 90 days after the event.
Zai Lab (NASDAQ: ZLAB) reported strong financial results for Q4 and full-year 2024. Total revenue grew 66% year-over-year to $109.1M in Q4 and 50% to $399.0M for full-year 2024. The company provided 2025 revenue guidance of $560-590M.
Key highlights include:
- VYVGART franchise generated $93.6M in net product revenue in its first full launch year
- Loss from operations decreased 45% y-o-y to $67.9M in Q4 and 23% to $282.1M for full-year
- Early clinical data for ZL-1310 showed 74% ORR in SCLC trial
- Cash position of $879.7M as of December 31, 2024
The company expects to achieve profitability on a non-GAAP basis by Q4 2025 and targets $2B in revenue by 2028, driven by VYVGART franchise expansion and upcoming potential blockbuster launches including KarXT for schizophrenia and bemarituzumab for gastric cancer.
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) has scheduled the release of its fourth quarter and full year 2024 financial results for February 27, 2025, before U.S. market opening. The company will host a conference call and webcast at 8:00 a.m. ET (9:00 p.m. HKT) on the same day to discuss the results and provide corporate updates.
Interested participants must register in advance through the provided registration link. Upon registration, they will receive dial-in details via confirmation email. A replay of the call will be available on the company's investor relations website.
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) has received Orphan Drug Designation (ODD) from the U.S. FDA for ZL-1310, their first-in-class DLL3 antibody-drug conjugate (ADC) designed to treat small cell lung cancer (SCLC). The designation comes after promising results from an ongoing Phase 1a/1b study in patients with previously treated extensive-stage SCLC.
The ODD grants several benefits, including waiver of Prescription Drug User Fee Act registration application fee, tax credits for certain clinical trials, and potential seven-year U.S. market exclusivity upon approval. The drug has shown promising objective response rates and favorable safety profile in Phase 1 trials for patients with recurrent SCLC.
Zai Lab (NASDAQ: ZLAB) announced that China's NMPA has accepted the New Drug Application for KarXT to treat adult schizophrenia. The application is supported by successful Phase 1 and Phase 3 trials in China, alongside global EMERGENT clinical program data.
The China Phase 3 study achieved its primary endpoint, showing a significant 9.2-point improvement over placebo in PANSS total score reduction (-16.9 KarXT vs. -7.7 placebo, p=0.0014). The study also met all key secondary efficacy endpoints. Common side effects included vomiting, tachycardia, nausea, hypertension, dizziness, and diarrhea.
With over 8 million schizophrenia patients in China facing treatment options, KarXT represents the first new treatment class in decades. The drug recently received FDA approval in September 2024 under the brand name COBENFY™, notably without atypical antipsychotic class warnings or boxed warnings.
