速递丨治疗胃癌,复宏汉霖抗PD-1单抗获NMPA纳入突破性治疗品种

医药观澜
Nov 21

11月20日,复宏汉霖宣布,创新型PD-1抑制剂H药斯鲁利单抗被中国国家药品监督管理局(NMPA)药品审评中心(CDE)正式纳入突破性治疗品种,联合化疗用于新辅助/辅助治疗胃癌。此前,H药针对该适应症的3期临床研究达到了主要终点,作为胃癌围手术期以免疫单药取代术后辅助化疗的治疗方案,有望为患者带来生存获益与生活质量提升的双重突破。胃癌是全球高发恶性肿瘤,发病率和死亡率均位居所有癌种的第五位。目前...

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