Hong Kong Approves TIVDAK for Advanced Cervical Cancer Treatment

Zai Lab Limited announced that TIVDAK has been approved in Hong Kong for treating advanced cervical cancer that has progressed on or after chemotherapy. TIVDAK is currently under review for its Biologics License Application by China's National Medical Products Administration. The approval in Hong Kong follows the acceptance of TIVDAK's BLA in March 2023.

Zai Lab Limited (ZLAB, 9688.HK) has announced that the Hong Kong Department of Health has approved TIVDAK (tisotumab vedotin-tftv) for the treatment of adult patients with recurrent or metastatic cervical cancer that has progressed on or after chemotherapy. This approval marks a significant milestone in the company's efforts to expand treatment options for advanced cervical cancer in Greater China [1].

TIVDAK is an antibody-drug conjugate (ADC) that combines a human monoclonal antibody directed to tissue factor (TF) with a microtubule-disrupting agent, monomethyl auristatin E (MMAE). The drug's mechanism of action involves binding to TF-expressing cancer cells, internalization, and release of MMAE, which disrupts the microtubule network and leads to cell cycle arrest and apoptotic cell death [2].

The approval in Hong Kong follows the acceptance of TIVDAK's Biologics License Application (BLA) by China's National Medical Products Administration (NMPA) in March 2025. TIVDAK has already received full approval from the U.S. Food and Drug Administration (FDA) for adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy [2].

Zai Lab, an innovative biopharmaceutical company based in China and the United States, has an exclusive license from Seagen Inc. (acquired by Pfizer) to develop and commercialize TIVDAK in Greater China. The company is focused on discovering, developing, and commercializing innovative products that address unmet medical needs in oncology, immunology, neuroscience, and infectious disease [2].

The approval of TIVDAK in Hong Kong further strengthens Zai Lab's Women's franchise in Greater China. The company is uniquely positioned to ensure that TIVDAK reaches patients without delay, leveraging its established commercial infrastructure for ZEJULA in Hong Kong [2].

References:
[1] https://www.rttnews.com/3570682/zai-lab-s-tivdak-approved-in-hong-kong-for-advanced-cervical-cancer-treatment.aspx
[2] https://www.morningstar.com/news/business-wire/20250901343152/zai-lab-announces-approval-of-tivdak-for-patients-with-recurrent-or-metastatic-cervical-cancer-in-hong-kong