恒瑞医药(600276.SH)子公司HRS-5965胶囊拟纳入优先审评程序

Core Viewpoint - Heng Rui Medicine (600276.SH) announced that its subsidiary Chengdu Shengdi Pharmaceutical Co., Ltd.'s HRS-5965 capsules have been proposed for inclusion in the priority review list by the National Medical Products Administration (NMPA) [1] Group 1: Product Information - HRS-5965 is intended for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria who have not previously received complement inhibitor therapy [1] - The proposed priority review is based on the application meeting the requirements outlined in the "Drug Registration Management Measures" and the announcement regarding the "Procedures for the Review of Breakthrough Therapy Drugs" [1] Group 2: Regulatory Context - The priority review is aimed at innovative drugs and modified new drugs that are urgently needed for clinical use, particularly for the treatment of major infectious diseases and rare diseases [1]