恒瑞医药(600276.SH)子公司HRS-5965胶囊拟纳入优先审评程序

智通财经
Nov 03, 2025

智通财经APP讯,恒瑞医药(600276.SH)发布公告,近日,公司子公司成都盛迪医药有限公司的HRS-5965胶囊被国家药品监督管理局药品审评中心拟纳入优先审评品种公示名单,公示期7日。

拟定适应症(或功能主治):治疗既往未接受过补体抑制剂治疗的阵发性睡眠性血红蛋白尿症成人患者。拟优先审评理由:经审核,本申请符合《药品注册管理办法》和《国家药监局关于发布<突破性治疗药物审评工作程序(试行)>等三个文件的公告》(2020年第82号)有关要求,同意按优先审评范围“(一)临床急需的短缺药品、防治重大传染病和罕见病等疾病的创新药和改良型新药”纳入优先审评审批程序。

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