科伦博泰生物(06990):SKB565新药临床试验申请获国家药品监督管理局批准

智通财经
Jul 27

智通财经APP讯,科伦博泰生物(06990)发布公告,本公司已收到国家药品监督管理局(NMPA)药品审评中心(CDE)同意新型双载荷ADC药物SKB565新药临床试验(IND)申请的临床试验通知书,用于治疗晚期实体瘤。这是本公司首个进入临床阶段的双载荷抗体偶联药物(ADC)。

凭藉在ADC领域的技术沉淀与平台优势,本公司已布局一系列结合高价值靶点、差异化设计并具备全球潜力的创新分子。在此基础上,本公司进一步拓展“ADC+肿瘤免疫学(IO)”策略-一方面聚焦优质联用疗法的探索,包括正在临床进行中的多种ADC与程序性细胞死亡蛋白(配体)1 (PD-(L)1) 单克隆抗体联合方案,以及PD-1╱血管内皮生长因子(VEGF)双特异性抗体SKB118与本公司众多专有ADC系列资产的联用;另一方面推进一体化策略研发,在单一ADC分子中整合具有协同作用机制的功能元件。

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