Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported that the Hong Kong Department of Health has granted approval for TIVDAK (tisotumab vedotin-tftv). The drug is indicated for adult patients with recurrent or metastatic cervical cancer whose disease progressed after initial chemotherapy.
Andrew Zhu, Chief Commercial Officer, Greater China, at Zai Lab, highlighted the significance of this approval. He noted that treatment options for patients with this type of advanced cervical cancer are limited. TIVDAK, as the first antibody-drug conjugate (ADC) therapy for this indication, offers a substantial improvement in patient survival. Zhu emphasized Zai Lab‘s readiness to quickly distribute TIVDAK in Hong Kong, leveraging their established commercial infrastructure.
TIVDAK‘s mechanism involves a targeted antibody linked to a cytotoxic agent. The antibody binds to tissue factor (TF) on cancer cells. This leads to the release of the cytotoxic agent inside the cancer cells, disrupting cell division and causing cell death. Preclinical studies support this mechanism of action. TIVDAK also exhibits antibody-dependent cellular phagocytosis and cytotoxicity.
The drug received full approval from the U.S. Food and Drug Administration (FDA) in April 2024 for a similar patient population. Zai Lab holds an exclusive license from Seagen Inc., now a part of Pfizer, to develop and commercialize TIVDAK in Greater China, which includes mainland China, Hong Kong, Macau, and Taiwan.
Zai Lab‘s Biologics License Application (BLA) for TIVDAK is currently under review by China‘s National Medical Products Administration (NMPA). The NMPA accepted the application in March 2025.
Zai Lab is a biopharmaceutical company focused on developing and commercializing innovative treatments for unmet medical needs. Their therapeutic areas of interest include oncology, immunology, neuroscience, and infectious diseases. The company operates in both China and the United States.
The company’s announcement included a cautionary statement about forward-looking information. These statements involve inherent uncertainties and risks, including those related to commercialization, funding, clinical trial outcomes, regulatory approvals, and business operations in China. Actual results may differ materially from the company’s projections.
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