Zai Lab Secures Approval for TIVDAK in Hong Kong, Enhancing Women's Franchise in Greater China

Zai Lab Ltd (ZLAB) has secured approval for TIVDAK in Hong Kong, marking a significant milestone for the company's Women's franchise in Greater China. TIVDAK is the first ADC therapy approved for cervical cancer, offering a clinically meaningful survival benefit. The approval strengthens Zai Lab's position in the oncology sector within Greater China and enhances its revenue streams in the region. However, the regulatory approval and commercialization of TIVDAK in mainland China remain critical for long-term market success.

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) has achieved a significant milestone in its Women's franchise by securing approval for TIVDAK (tisotumab vedotin-tftv) in Hong Kong. The drug is now available for the treatment of adult patients with recurrent or metastatic cervical cancer who have experienced disease progression on or after chemotherapy. This approval marks the first time an antibody-drug conjugate (ADC) therapy has been approved for cervical cancer in the region.

The approval is a testament to Zai Lab's commitment to addressing unmet medical needs, particularly in the oncology sector. TIVDAK, which received full approval from the U.S. Food and Drug Administration (FDA) in April 2024, delivers a clinically meaningful survival benefit to patients. The drug's approval in Hong Kong strengthens Zai Lab's position in the Greater China market and enhances its revenue streams in the region.

Andrew Zhu, Chief Commercial Officer, Greater China, Zai Lab, stated, "Today’s approval of TIVDAK marks an important milestone for Zai Lab, further strengthening our Women’s franchise in Greater China. 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."

While the approval in Hong Kong is a significant achievement, the regulatory approval and commercialization of TIVDAK in mainland China remain critical for long-term market success. Zai Lab's Biologics License Application for TIVDAK is currently under review by China's National Medical Products Administration (NMPA), which was accepted in March 2025.

TIVDAK is an ADC composed of Genmab’s human monoclonal antibody directed to tissue factor (TF) and Pfizer’s ADC technology. It utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody. The drug's mechanism of action involves 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.

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). The approval in Hong Kong is a step forward in Zai Lab's strategic plan to expand its market presence and enhance its revenue streams in the region.

References:
[1] https://www.biospace.com/press-releases/zai-lab-announces-approval-of-tivdak-for-patients-with-recurrent-or-metastatic-cervical-cancer-in-hong-kong
[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