China’s NMPA issued an approval for Tivdak (tisotumab vedotin) as a treatment for recurrent or metastatic cervical cancer, making it the first antibody-drug conjugate cleared for this indication in China. Zai Lab Limited (Nasdaq: ZLAB; HKEX: 9688) holds exclusive rights to the drug across Greater China under a license originally executed with Seagen — subsequently acquired by Pfizer — and will be responsible for its commercialization. With an estimated 150,000 new cervical cancer diagnoses annually in China, the approval addresses a population where treatment options after platinum-based chemotherapy remain limited.
The NMPA approved Tivdak for adult patients with recurrent or metastatic cervical cancer whose disease has progressed on or after chemotherapy, administered intravenously. Tisotumab vedotin is an ADC comprising a human monoclonal antibody directed against tissue factor (TF), developed by Genmab, conjugated via a protease-cleavable linker to monomethyl auristatin E (MMAE), using Pfizer’s ADC platform technology. Upon binding to TF-expressing tumor cells, the ADC-TF complex is internalized and MMAE is released, disrupting microtubule polymerization and triggering cell cycle arrest and apoptosis.
The approval is supported by the global, randomized Phase III innovaTV 301 trial (NCT04697628), which enrolled adults with previously treated recurrent or metastatic cervical cancer. The trial met its primary endpoint of overall survival (OS) in the intention-to-treat population, with a hazard ratio of 0.70 (95% CI: 0.54–0.89; p=0.0038) versus investigator’s choice chemotherapy. A prespecified China subpopulation analysis, presented at the 2025 Chinese Society of Clinical Oncology meeting, showed an HR of 0.55 (95% CI: 0.27–1.15), corresponding to a reported 45% reduction in the risk of death. Notably, 54.1% of the China subpopulation had received prior anti-PD-(L)1 therapy, and OS benefit trends remained consistent regardless of prior immunotherapy exposure.