Zai Lab has announced that China’s National Medical Products Administration (NMPA) has approved its Biologics Licence Application (BLA) for TIVDAK (tisotumab vedotin-tftv) for the treatment of patients with recurrent or metastatic cervical cancer who have experienced disease progression after systemic therapy..

再鼎医药宣布，中国国家药品监督管理局 (NMPA) 已批准其 TIVDAK（tisotumab vedotin-tftv）的生物制品许可申请 (BLA)，用于治疗既往接受过系统治疗后出现疾病进展的复发性或转移性宫颈癌患者。

Cervical cancer is a leading cause of cancer-related death among women in China, with a high number of new cases each year. Treatment options for recurrent or metastatic cervical cancer remain limited. TIVDAK has the potential to provide a new option for patients with advanced disease who have exhausted other treatments..

宫颈癌是中国女性癌症相关死亡的主要原因之一，每年新发病例数量众多。对于复发性或转移性宫颈癌，治疗选择仍然有限。TIVDAK 有潜力为那些已用尽其他治疗方案的晚期患者提供一种新的选择。

TIVDAK is an ADC that combines a monoclonal antibody targeting tissue factor (TF) with an anti-cancer agent. It is designed to bind to TF-expressing cancer cells, leading to internalisation of the drug and subsequent cell death. The treatment also engages immune system mechanisms to enhance its effect..

TIVDAK是一种抗体药物偶联物（ADC），它将靶向组织因子（TF）的单克隆抗体与抗癌药物结合。其设计旨在与表达TF的癌细胞结合，促使药物内化并导致细胞死亡。该疗法还利用免疫系统机制来增强其效果。

Cervical cancer remains a major health issue in China, with approximately 150,000 new cases diagnosed annually. Treatment options for patients with recurrent or metastatic disease after initial therapy are currently limited. TIVDAK, an antibody-drug conjugate (ADC), has shown promising results, including improved overall survival in the pivotal global Phase 3 innovaTV 301 trial..

宫颈癌仍然是中国面临的一个主要健康问题，每年约有150,000例新发病例。对于初始治疗后复发或转移性疾病的患者，目前的治疗选择有限。TIVDAK是一种抗体药物偶联物（ADC），在关键的全球III期innovaTV 301试验中显示出良好的结果，包括总生存期的改善。

The approval is supported by data from this clinical trial (NCT04697628), including results from a China-specific subpopulation. Findings from this group, reported in early 2025, were in line with the global trial results.

该批准得到了这项临床试验（NCT04697628）数据的支持，其中包括来自中国特定亚组人群的结果。该组人群的研究结果于2025年初公布，与全球试验结果一致。

TIVDAK reduced the risk of death by 45% compared to chemotherapy (HR: 0.55 [95% CI: 0.27-1.15]) in patients who had received prior standard treatments, including anti-PD(L)1 therapy. At a median follow-up of 11.5 months, the median overall survival had not been reached in the TIVDAK group, compared to 10.7 months in the chemotherapy group..

与化疗相比，TIVDAK在先前接受过标准治疗（包括抗PD(L)1疗法）的患者中将死亡风险降低了45%（HR: 0.55 [95% CI: 0.27-1.15]）。在中位随访11.5个月时，TIVDAK组的中位总生存期尚未达到，而化疗组为10.7个月。

Secondary outcomes, such as progression-free survival and objective response rate, also showed a benefit with TIVDAK. The safety profile in Chinese patients was consistent with global data.

次要终点如无进展生存期和客观缓解率也显示出TIVDAK的益处。中国患者的安全性数据与全球数据一致。

Zai Lab holds an exclusive licence from Seagen Inc., which was acquired by Pfizer in 2023, to develop and commercialise TIVDAK in Greater China, including mainland China, Hong Kong, Macau, and Taiwan.

再鼎医药持有由Seagen Inc.（该公司于2023年被辉瑞收购）授予的独家许可，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。

Source: zailaboratory.com

来源：zailaboratory.com