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.

再鼎医药已获得香港卫生署批准TIVDAK®（tisotumab vedotin-tftv）用于治疗化疗后疾病进展的复发性或转移性宫颈癌成人患者。

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.

TIVDAK®（tisotumab vedotin）是一种使用Genmab的人源单克隆抗体靶向组织因子（TF）和辉瑞的ADC技术研发的抗体药物偶联物（ADC）。该药物通过一种蛋白酶可切割的连接子将微管破坏剂单甲基澳瑞他汀E（MMAE）连接到抗体上。

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..

该治疗通过与表达TF的癌细胞结合起效，之后ADC被内化并释放MMAE。这一过程破坏细胞周期并诱导程序性细胞死亡。实验室研究还表明，该疗法可以激活免疫反应，例如抗体依赖性细胞吞噬作用和细胞毒性。

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.

2024年4月，TIVDAK获得美国食品药品监督管理局（FDA）的全面批准，用于化疗后复发或转移性宫颈癌患者。

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.

再鼎医药持有Seagen公司（现为辉瑞的一部分）的独家许可，可在大中华地区（包括中国大陆、香港、澳门和台湾）开发和商业化TIVDAK。

The authorisation makes TIVDAK the first antibody-drug conjugate (ADC) available for cervical cancer in Hong Kong.

该授权使TIVDAK成为香港首个可用于宫颈癌的抗体药物偶联物（ADC）。

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.

TIVDAK也在中国大陆接受监管审查，国家药品监督管理局（NMPA）于2025年3月接受了该公司的生物制品许可申请。

The therapy has been shown to provide meaningful survival benefits for patients with limited treatment options.

该疗法已被证明可为治疗选择有限的患者提供有意义的生存益处。

Source: zailaboratory.com

来源：zailaboratory.com