Zai Lab Secures China NMPA Approval for TIVDAK, First ADC for Recurrent or Metastatic Cervical Cancer
核心洞察
China's NMPA has approved TIVDAK (tisotumab vedotin) as the first antibody-drug conjugate for previously treated recurrent or metastatic cervical cancer (搜索) in China.
The approval is supported by the global Phase 3 innovaTV 301 trial, which showed a statistically significant overall survival benefit (HR=0.70, p=0.0038) versus chemotherapy.
The China subpopulation demonstrated a 45% reduction in the risk of death (HR: 0.55), with consistent benefit regardless of prior anti-PD(L)1 therapy exposure.
Zai Lab Limited announced on June 8, 2026, that China's National Medical Products Administration (NMPA) has approved the Biologics License Application (BLA) for TIVDAK (tisotumab vedotin for injection), making it the first antibody-drug conjugate (ADC) approved in China for the treatment of adult patients with recurrent or metastatic cervical cancer (搜索) whose disease has progressed on or after chemotherapy.
The regulatory milestone addresses a significant unmet medical need in China, where an estimated 150,000 new cases of cervical cancer occur annually and the disease remains one of the leading causes of cancer death among women.
"Cervical cancer remains one of the leading causes of cancer death in women in China. Antibody-drug conjugates have proven to be novel and effective treatments for many types of cancer, and we are pleased to bring this innovative therapeutic class to patients in China with cervical cancer," said Rafael G. Amado, M.D., President and Head of Global Research and Development at Zai Lab.
Robust Clinical Evidence from innovaTV 301
The NMPA approval is anchored by results from the global, randomized Phase 3 innovaTV 301 clinical trial, which met its primary endpoint of overall survival (OS) in the intention-to-treat (ITT) population. In the global study, TIVDAK demonstrated a statistically significant OS benefit compared to chemotherapy, with a hazard ratio of 0.70 (95% CI: 0.54–0.89; two-sided p=0.0038).
The China subpopulation, conducted as an exploratory analysis by Zai Lab, showed consistent and clinically meaningful results. Patients in this subgroup experienced a 45% reduction in the risk of death compared to those receiving chemotherapy (HR: 0.55, 95% CI: 0.27–1.15).
Notably, 54.1% of the China subpopulation had received prior anti-PD(L)1 therapy, which represents the current standard of care for second-line treatment of cervical cancer. TIVDAK demonstrated consistent OS benefit trends irrespective of prior immunotherapy exposure.
"Treatment options are very limited for cervical cancer patients once recurrence or metastasis occurs," said Dr. Lingying Wu, Ph.D., China Leading Principal Investigator of the innovaTV 301 Study and Professor of the Department of Gynecologic Oncology at the National Cancer Center / Cancer Hospital Chinese Academy of Medical Sciences. "Consistent with findings from the global innovaTV 301 trial, the China subpopulation data demonstrate that TIVDAK offers significant clinical benefits to these patients, irrespective of prior PD-(L)1 inhibitor therapy."
Safety Profile
No new safety signals were identified among patients in the China subpopulation who received TIVDAK. In the global study, the most common Grade ≥3 treatment-emergent adverse events (TEAEs) were anemia (8.4%), urinary tract infection (4.4%), and abdominal pain (4.0%). In the China subpopulation, the most common Grade ≥3 TEAEs were anemia (11.4%), cough (5.7%), and malaise (5.7%).
Mechanism of Action and Global Regulatory Footprint
Tisotumab vedotin is an ADC composed of Genmab's human monoclonal antibody directed to tissue factor (搜索) (TF) and Pfizer's ADC technology, which utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody. The ADC binds to TF-expressing cancer cells, followed by internalization and release of MMAE via proteolytic cleavage, leading to cell cycle arrest and apoptotic cell death. In vitro, tisotumab vedotin also mediates antibody-dependent cellular phagocytosis and antibody-dependent cellular cytotoxicity.
The NMPA approval follows regulatory approvals in the United States, Japan, the European Union, the United Kingdom, Macau (China), and Hong Kong (China). TIVDAK received full approval from the U.S. Food and Drug Administration in April 2024, with initial U.S. approval secured in September 2021 under the accelerated approval pathway.
Zai Lab holds an exclusive license from Seagen Inc., a company later acquired by Pfizer, for TIVDAK in Greater China (mainland China, Hong Kong, Macau, and Taiwan). The company plans to leverage its extensive experience and expanding presence in the Chinese gynecologic oncology community, along with commercial synergies from its ZEJULA team, to bring TIVDAK to patients across China.