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Hong Kong has approved TIVDAK for treating recurrent or metastatic cervical cancer. Zai Lab's Chief Commercial Officer, Andrew Zhu, stated that this is an important milestone for the company, as TIVDAK delivers a clinically meaningful survival benefit to patients. TIVDAK is currently under review for a Biologics License Application by China's NMPA.

Hong Kong has approved TIVDAK (tisotumab vedotin-tftv) for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. This approval marks a significant milestone for Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), as it expands the company's Women's franchise in Greater China [1].

Zai Lab's Chief Commercial Officer, Andrew Zhu, stated that this approval is an important step forward for the company, highlighting that TIVDAK delivers a clinically meaningful survival benefit to patients. With the established commercial infrastructure for ZEJULA in Hong Kong, Zai Lab is well-positioned to ensure TIVDAK reaches patients without delay [1].

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 [1]. The drug is an antibody-drug conjugate (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. 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 [1].

TIVDAK received full approval from the 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 [1]. 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) [1].

Zai Lab is an innovative, research-based, commercial-stage biopharmaceutical company focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease [1]. The company's goal is to leverage its competencies and resources to positively impact human health.

References:
[1] https://www.businesswire.com/news/home/20250901343152/en/Zai-Lab-Announces-Approval-of-TIVDAK-for-Patients-with-Recurrent-or-Metastatic-Cervical-Cancer-in-Hong-Kong