Zai Lab Receives Approval for TIVDAK® in Hong Kong for Cervical Cancer Patients
Tuesday, September 02, 2025
Zai Lab has received approval from the Hong Kong Department of Health for TIVDAK® (tisotumab vedotin-tftv) to treat adults with recurrent or metastatic cervical cancer whose disease has progressed after chemotherapy.
TIVDAK® (tisotumab vedotin) is an ADC developed using Genmab’s human monoclonal antibody that targets tissue factor (TF) and Pfizer’s ADC technology. The drug uses a protease-cleavable linker to attach monomethyl auristatin E (MMAE), a microtubule-disrupting agent, to the antibody.
The treatment works by binding to TF-expressing cancer cells, after which the ADC is internalised and MMAE is released. This process disrupts the cell cycle and induces programmed cell death. Laboratory studies also suggest that the therapy can activate immune responses such as antibody-dependent cellular phagocytosis and cytotoxicity.
TIVDAK gained full approval from the US Food and Drug Administration (FDA) in April 2024 for use in patients with recurrent or metastatic cervical cancer after chemotherapy.
Zai Lab holds an exclusive licence from Seagen Inc., now part of Pfizer, to develop and commercialise TIVDAK in Greater China, including mainland China, Hong Kong, Macau and Taiwan.
The authorisation makes TIVDAK the first antibody-drug conjugate (ADC) available for cervical cancer in Hong Kong.
TIVDAK is also under regulatory review in mainland China, where the National Medical Products Administration (NMPA) accepted the company’s Biologics Licence Application in March 2025.
The therapy has been shown to provide meaningful survival benefits for patients with limited treatment options.
Source: zailaboratory.com
