Tilray® (Vetisortuzumab for Injection) Approved by the National Medical Products Administration for the Treatment of Adult Patients with Recurrent or Metastatic Cervical Cancer

– Tisotumab vedotin is the first antibody-drug conjugate (ADC) approved in China for previously treated recurrent or metastatic cervical cancer

– Tisotumab vedotin demonstrated a statistically significant overall survival benefit in the global Phase 3 innovaTV 301 clinical study (including data from the China subpopulation)

Shanghai, China and Cambridge, Massachusetts, USAJune 9, 2026 /PRNewswire/ — Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) announced on June 8, 2026, that the National Medical Products Administration (NMPA) has approved the Biologics License Application (BLA) for TIVDAK^® (tisotumab vedotin for injection) for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. The approval is based on results from the global, randomized, controlled Phase 3 innovaTV 301 clinical study. The study met its primary endpoint, demonstrating an overall survival (OS) benefit with tisotumab vedotin compared to chemotherapy in adult patients with previously treated recurrent or metastatic cervical cancer, including in the exploratory China subpopulation.

Following approvals in the United States, Japan, the European Union, the United Kingdom, Macau, and Hong Kong, the NMPA approval of tisotumab vedotin further underscores the robust global clinical evidence supporting its introduction in China. The indication wording varies slightly across different regions.

“Cervical cancer remains one of the leading causes of cancer death among women in China. Antibody-drug conjugates represent an innovative and effective treatment option for many cancer types, and we are delighted to bring this novel therapy to cervical cancer patients in China,” said Dr. Rafael G. Amado, President and Head of Global R&D at Zai Lab. “Combined with the prior global approvals of tisotumab vedotin for this disease, this BLA approval in China further validates the solid global clinical benefit evidence for this therapy in advanced patients with limited treatment options.”

Results from the Phase 3 innovaTV 301 clinical study, including data from the China subpopulation conducted by Zai Lab, supported the global approval of tisotumab vedotin:

• In the China subpopulation, 54.1% of patients had received prior anti-PD-(L)1 antibody therapy, which is the current second-line standard of care for cervical cancer. Tisotumab vedotin showed a consistent trend of OS benefit regardless of prior immunotherapy exposure^[2].
• No new safety signals were identified in the China subpopulation treated with tisotumab vedotin. The most common ≥Grade 3 treatment-emergent adverse events (TEAEs) in the global study were anemia (8.4%), urinary tract infection (4.4%), and abdominal pain (4.0%)^[1]. The most common ≥Grade 3 TEAEs in the China subpopulation were anemia (11.4%), cough (5.7%), and fatigue (5.7%)^[2].

“Once cervical cancer recurs or metastasizes, treatment options for patients become very limited,” said Professor Wu Lingying, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences, and principal investigator of the innovaTV 301 study in China. “The China subpopulation data are consistent with the overall results of the global innovaTV 301 study, showing that tisotumab vedotin can provide significant clinical benefit to patients, regardless of prior anti-PD-(L)1 antibody therapy.”

Zai Lab will leverage its deep experience in the women’s oncology field in China and its expanding market presence, utilizing commercial synergies with the ZEJULA^® team, to make tisotumab vedotin accessible to patients in China.

About Cervical Cancer in China

It is estimated that there are approximately 150,000 new cases of cervical cancer in China each year^[3]. For patients with recurrent or metastatic cervical cancer whose disease progresses during or after systemic therapy, current treatment options are limited. Tisotumab vedotin is expected to provide a new treatment option for previously treated advanced cervical cancer patients.

About Tisotumab Vedotin

Tisotumab vedotin (marketed as TIVDAK^® in the EU, US, UK, and Japan) is an antibody-drug conjugate (ADC) composed of a human monoclonal antibody targeting tissue factor (TF) from Genmab and Pfizer’s ADC technology, which uses a protease-cleavable linker to covalently attach the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody. Nonclinical data suggest that the anticancer activity of tisotumab vedotin is due to the ADC binding to TF-expressing cancer cells, followed by internalization of the ADC-TF complex and release of MMAE via proteolytic cleavage. MMAE disrupts the microtubule network of actively dividing cells, leading to cell cycle arrest and apoptotic cell death. In vitro, tisotumab vedotin also mediates antibody-dependent cellular phagocytosis and antibody-dependent cellular cytotoxicity.

Tisotumab vedotin received full approval from the U.S. Food and Drug Administration (FDA) in April 2024. The drug was initially approved in the U.S. in September 2021 under an accelerated approval pathway for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. The drug has been approved for the same indication in Japan, the European Union, Macau, and Hong Kong.

Zai Lab obtained an exclusive license from Seagen Inc. (subsequently acquired by Pfizer) for tisotumab vedotin in Greater China (comprising mainland China, Hong Kong, Macau, and Taiwan). Zai Lab is solely responsible for the development, supply, and commercialization of tisotumab vedotin in Greater China.

About Zai Lab

Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is a research-based, commercial-stage innovative biopharmaceutical company headquartered in China and the United States. We are dedicated to addressing significant unmet medical needs in oncology, immunology, neuroscience, and infectious diseases through the discovery, development, and commercialization of innovative products. Our goal is to leverage our capabilities and resources to improve human health and well-being in China and around the world.

For more information about Zai Lab, please visit www.zailaboratory.com or follow the company’s official WeChat account: Zai Lab.

Zai Lab Forward-Looking Statements

This press release contains forward-looking statements about Zai Lab’s future expectations, plans, and prospects, including but not limited to statements regarding the prospects and plans for the development and commercialization of tisotumab vedotin in Greater China, the potential benefits of tisotumab vedotin, and potential therapies for cervical cancer. Such forward-looking statements may contain words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would,” and other similar expressions. These statements constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact, nor are they guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those anticipated in the forward-looking statements. Actual results may differ materially from those indicated in the forward-looking statements due to various important factors, including but not limited to: (1) our ability to successfully commercialize our approved products and generate revenue from them; (2) our ability to obtain funding for our operations and business activities; (3) the results of clinical and preclinical development of our product candidates; (4) the content and timing of decisions by relevant regulatory authorities regarding our product candidates; (5) risks associated with doing business in China; and (6) other factors identified in our most recent annual and quarterly reports filed with the U.S. Securities and Exchange Commission (SEC) and other reports. We expect that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

For copies of documents filed with the SEC, please visit the company’s website at www.zailaboratory.com and the SEC website at www.SEC.gov.

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