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 research-based, commercial-stage biopharmaceutical company based in China and the United States, with a focus on oncology, immunology, neuroscience, and infectious disease. The Zai Lab news feed on Stock Titan aggregates company announcements, clinical updates, regulatory milestones, and financial disclosures that the company releases through channels such as Business Wire and SEC filings.
Investors and followers of ZLAB stock can use this page to review news on Zai Lab’s global pipeline, including progress of assets like zocilurtatug pelitecan (zoci), a DLL3-targeted antibody-drug conjugate for extensive-stage small cell lung cancer and other neuroendocrine carcinomas, and ZL-1503, an IL-13/IL-31R bispecific antibody for atopic dermatitis. Updates on other oncology and immunology programs, such as ZL-6201, ZL-1222, and ZL-1311, also appear in company press releases.
The news stream highlights regulatory developments in Greater China, including National Medical Products Administration (NMPA) approvals and National Reimbursement Drug List (NRDL) decisions for products in Zai Lab’s commercial portfolio. Recent examples include announcements about COBENFY for schizophrenia and AUGTYRO for ROS1-positive non-small cell lung cancer and NTRK-positive solid tumors, as well as renewals and coverage decisions for VYVGART, NUZYRA, and ZEJULA.
In addition, this page surfaces Zai Lab’s financial result releases, conference call notices, and participation in healthcare and investor conferences. These items provide context on revenue trends, R&D spending, and the company’s dual-engine strategy combining a China commercial business with a global innovation platform. Bookmark this page to quickly access ZLAB-related news, organized in one place for efficient review of the company’s ongoing clinical, regulatory, and corporate developments.
Zai Lab (NASDAQ: ZLAB) reported updated Phase 1 data for zocilurtatug pelitecan (zoci) in extensive-stage small cell lung cancer (ES-SCLC) as of Sept 15, 2025. In 102 evaluable patients, zoci showed high activity across doses, including a 68% ORR in the 1.6 mg/kg second-line cohort (n=19) and an 80% ORR in patients with brain metastases who had not received prior brain radiotherapy (n subset). Median duration of response was 6.1 months and median PFS was 5.4 months. Safety at 1.6 mg/kg showed 13% Grade ≥3 TRAEs and no discontinuations for toxicity in that cohort. A global Phase 3 registrational study (≈665 patients, NCT07218146) has opened for enrollment.
Zai Lab (NASDAQ: ZLAB) will report third quarter 2025 financial results and provide corporate updates on November 6, 2025, before U.S. markets open. A conference call and live webcast will follow at 8:00 a.m. ET (9:00 p.m. HKT). Participants must register in advance using the provided webcast or dial-in registration links. Dial-in details will be sent in the confirmation email after registration. A replay will be posted on the company website shortly after the call. The live webcast is accessible via the company's investor site and the listed media-server registration pages.
Zai Lab (NASDAQ: ZLAB) announced an oral presentation of updated data for zocilurtatug pelitecan (zoci) from its global Phase 1 trial (NCT06179069) at the AACR-NCI-EORTC conference in Boston, Oct 22–26, 2025.
The late-breaking abstract features additional follow-up in previously treated extensive-stage small cell lung cancer (ES-SCLC). Zai Lab said it remains on track to initiate a Phase 3 registrational study by year-end 2025. An investor webcast and conference call to discuss the data and plans is scheduled for Oct 24, 2025, 11:00 a.m. ET.
Zai Lab (NASDAQ: ZLAB) has received approval from the Hong Kong Department of Health for TIVDAK (tisotumab vedotin-tftv), a groundbreaking treatment for adult patients with recurrent or metastatic cervical cancer who experienced disease progression during or after chemotherapy.
TIVDAK represents a significant advancement as the first antibody-drug conjugate (ADC) therapy for cervical cancer, offering meaningful survival benefits. The company plans to leverage its existing ZEJULA commercial infrastructure in Hong Kong for immediate distribution. Additionally, TIVDAK's Biologics License Application is currently under review by China's National Medical Products Administration (NMPA), following its acceptance in March 2025.
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) announced its participation in two major healthcare investor conferences in September 2025. The company will present at the Cantor Global Healthcare Conference on September 4 at 10:20 a.m. ET and participate in a fireside chat at the Morgan Stanley 23rd Annual Global Healthcare Conference on September 9 at 2:35 p.m. ET. Both events will take place in New York.
Investors can access live webcasts of both presentations through Zai Lab's Investor Relations website, with recordings available for 90 days after the events.
Zai Lab (NASDAQ: ZLAB) has received Innovative Medical Device Designation from China's NMPA for Tumor Treating Fields (TTFields) in pancreatic cancer treatment, following positive Phase 3 PANOVA-3 trial results. This designation enables expedited regulatory review and allows submission before approval in the country of origin.
The Phase 3 PANOVA-3 trial evaluated TTFields with gemcitabine and nab-paclitaxel as first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma. The trial met its primary endpoint with statistically significant improvement in median overall survival. Zai Lab plans to submit for regulatory approval in China in H2 2025.
Zai Lab (NASDAQ: ZLAB) has announced the formation of its Oncology Scientific Advisory Board (SAB), comprising eight distinguished leaders in oncology research and clinical practice. The advisory board will support the advancement of the company's oncology products and pipeline, including internally developed therapies.
The newly formed SAB includes prominent experts from prestigious institutions such as Yale University School of Medicine, UCLA, University of Chicago, Sarah Cannon Research Institute, University of Manchester, Yale Cancer Center, University of Pittsburgh Medical Center, and MD Anderson Cancer Center. Dr. Rafael G. Amado, President and Head of Global R&D at Zai Lab, emphasized the significance of this development for advancing innovative treatment options for patients globally.
Zai Lab (NASDAQ: ZLAB) reported Q2 2025 financial results with total revenues growing 9% year-over-year to $110.0 million. The company reaffirmed its full-year 2025 revenue guidance of $560-590 million. Operating loss improved by 28% year-over-year to $54.9 million, with the company on track to achieve profitability in Q4 2025.
Key highlights include VYVGART's record patient utilization and ZL-1310's promising clinical data showing 67% overall response rate in second-line SCLC. The successful Phase 3 FORTITUDE-101 study of bemarituzumab in gastric cancer met its primary endpoint, with China regulatory submission expected in H2 2025.
The company maintains a strong financial position with $832.3 million in cash and equivalents as of June 30, 2025, supporting its commercial expansion and pipeline development.
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) has scheduled its second quarter 2025 financial results announcement and corporate updates for August 7, 2025, before U.S. markets open. 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 must register in advance through the provided links to access either the webcast or dial-in options. A replay of the event will be available on the company's website after the call.
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.