H药拿下全球首个!胃癌“免化疗”方案即将上市

健识局
Dec 16, 2025

12月15日,复宏汉霖发布公告称,PD-1斯鲁利单抗“H药”联合含铂化疗新辅助治疗,在手术后辅助治疗,用于PD-L1阳性、可手术切除的胃癌适应症上市注册申请获得国家药监局受理,并纳入优先审评审批程序。根据国家药审中心的相关规定,纳入优先审评审批程序的药品,技术审评时限将大幅缩短至130个工作日。如果一切顺利的话,H药胃癌围手术期治疗适应症或将明年上半年获批上市。H药的突破,将免疫治疗推向一个新的...

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