科伦博泰生物-B(06990)：ITGB6 ADC SKB105新药临床试验申请获国家药品监督管理局批准

智通财经

Jan 04

智通财经APP讯，科伦博泰生物-B(06990)发布公告，公司自主研发的靶向整合素β6(ITGB6)抗体偶联药物(ADC)SKB105(亦称CR-003)的新药临床试验(IND)申请已获中国国家药品监督管理局(NMPA)药品审评中心(CDE)批准，用于治疗晚期实体瘤。

2025年12月，公司与Crescent Biopharma, Inc.就SKB105/CR-003与SKB118(程序性细胞死亡蛋白-1(PD-1)x血管内皮生长因子(VEGF)双特异性抗体，亦称CR-001)达成战略合作，其中公司授予Crescent在美国、欧洲及所有其他大中华地区(包括中国内地、香港、澳门及台湾)以外市场研究、开发、生产和商业化SKB105/CR-003的独家权利，Crescent则授予公司在大中华地区研究、开发、生产和商业化SKB118/CR-001的独家权利。公司计划于近期向中国国家药品监督管理局药品审评中心递交SKB118/CR-001的IND申请。

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