关注,又新增2款国产创新药拟纳入突破性疗法

北京药研汇
Dec 19, 2025

纳入“突破性治疗药物”名单的新药是指用于防治严重危及生命或者严重影响生存质量的疾病,且尚无有效防治手段,或者与现有治疗手段相比有足够证据表明具有明显临床优势的创新药或者改良型新药。近日,2025年12月17日,根据国家药品监督管理局药品审评中心(CDE)官网显示,2款国产创新药拟纳入突破性疗法,分别来自恒瑞医药、宁波新湾科技。其中,恒瑞医药本次拟纳入突破性疗法的产品为注射用SHR-A1904,拟...

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