港股异动 | 李氏大药厂(00950)涨超7% ZK2401于中国提交新药临床试验申请已获NMPA受理

智通财经
Aug 14

智通财经APP获悉,李氏大药厂(00950)涨超7%,截至发稿,涨7.27%,报1.18港元,成交额201.32万港元。

消息面上,近期,李氏大药厂发布公告,本集团就ZK2401于中国的新药临床试验(IND)申请已获得中国国家药品监督管理局(NMPA)药品评审中心受理。ZK2401为李氏大药厂自主研发的专有抗体药物偶联物(ADC)项目,由李氏大药厂拥有该分子的完整全球知识产权。ZK2401建基于李氏大药厂自主研发的抗PD-L1抗体索卡佐利单抗(Socazolimab),并偶联新型拓扑异构酶I抑制剂载荷。作为李氏大药厂ADC平台的首个项目,ZK2401标志着本集团推进该平台发展的一个重要起点。

董事会认为,提交此项IND申请为本集团肿瘤领域创新管线的一个重要里程碑。该项目体现李氏大药厂在完全自主开发创新生物及ADC资产方面的持续独立研发能力,并符合本集团策略重点,即专注于以专利技术为基础、具有重大临床潜力及有防守竞争优势的差异化产品。截至目前,索卡佐利单抗已获中国NMPA批准上市,用于两项适应症:联合化疗一线治疗广泛期小细胞肺癌(ES-SCLC),以及治疗复发性或转移性宫颈癌。

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