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信达生物(01801.HK)旗下治疗晚期肝癌新药研究达到主要研究终点
阿思达克 09-28 08:47
信达生物(01801.HK)公布,达伯舒(信迪利单抗注射液)联合达攸同(贝伐珠单抗生物类似药)用於晚期肝癌一线治疗的III期临床研究(ORIENT-32)在期中分析达到无进展生存期(PFS)及总生存期(OS)的主要研究终点。这是全球首个公布达到主要研究终点的程序性细胞死亡蛋白1(PD-1)抑制剂联合治疗用於晚期肝癌一线治疗的III期研究。

公司计划就递交达伯舒(信迪利单抗注射液)联合达攸同(贝伐珠单抗生物类似药)用於晚期肝癌一线治疗的新适应症上市申请(sNDA)与国家药品监督管理局(NMPA)药品审评中心进行沟通。

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