On September 1, 2025 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported the Hong Kong Department of Health has approved TIVDAK (tisotumab vedotin-tftv) in Hong Kong for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy (Press release, Zai Laboratory, SEP 1, 2025, View Source [SID1234655613]).
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"Today’s approval of TIVDAK marks an important milestone for Zai Lab, further strengthening our Women’s franchise in Greater China," said Andrew Zhu, Chief Commercial Officer, Greater China, Zai Lab. "Treatment options for patients with recurrent or metastatic cervical cancer after initial therapy are limited. TIVDAK, the first antibody-drug conjugate (ADC) therapy in cervical cancer, delivers a clinically meaningful survival benefit to patients. With our established commercial infrastructure for ZEJULA in Hong Kong, we are uniquely positioned to ensure TIVDAK reaches patients without delay."
TIVDAK is currently under regulatory review for its Biologics License Application by China’s National Medical Products Administration (NMPA), which was accepted in March 2025.
About TIVDAK (tisotumab vedotin-tftv)
TIVDAK (tisotumab vedotin) is an ADC composed of Genmab’s human monoclonal antibody directed to tissue factor (TF) and Pfizer’s ADC technology that utilizes a protease-cleavable linker that covalently attaches 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 binding of the ADC 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.
TIVDAK received full approval from U.S. Food and Drug Administration (FDA) in April 2024 for adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
Zai Lab has an exclusive license from Seagen Inc., acquired by Pfizer, to develop and commercialize TIVDAK in Greater China (mainland China, Hong Kong, Macau, and Taiwan, collectively).