China NMPA approves Zai Lab’s TIVDAK for recurrent or metastatic Cervical cancer

CAR-T Digest - August 2020

Weekly Digest - June 2026

08 June 2026: China NMPA approves Zai Lab’s TIVDAK for recurrent or metastatic Cervical cancer

Zai Lab has received approval from China’s National Medical Products Administration for TIVDAK for the treatment of adult patients with recurrent or metastatic cervical cancer whose disease has progressed on or after chemotherapy, bringing the first approved ADC for this setting to patients in China
The approval was supported by results from the global phase 3 innovaTV 301 trial, where TIVDAK demonstrated a statistically significant overall survival benefit versus chemotherapy in previously treated recurrent or metastatic cervical cancer, reducing the risk of death by 30% (HR=0.70) and achieving a median overall survival of 11.5 months versus 9.5 months, with consistent efficacy observed in the China patient subgroup
TIVDAK becomes the first antibody-drug conjugate approved in China for previously treated recurrent or metastatic cervical cancer, providing a new treatment option for patients who historically faced limited therapeutic choices and poor outcomes after disease progression
TIVDAK is a tissue factor-directed ADC that combines a human monoclonal antibody targeting TF with a protease-cleavable linker and the microtubule-disrupting payload MMAE, enabling selective delivery of cytotoxic therapy to tumor cells
Strategically, the approval strengthens Zai Lab’s oncology franchise in Greater China by adding a globally validated ADC to its commercial portfolio, while establishing an early leadership position in cervical cancer ADC therapy and reinforcing the growing role of ADCs in gynecologic oncology