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恒瑞医药:HRS-5965胶囊药物拟纳入优先审评程序

Core Viewpoint - Heng Rui Medicine's subsidiary Chengdu Shengdi Pharmaceutical Co., Ltd. has announced that its HRS-5965 capsule is proposed to be included in the priority review list by the National Medical Products Administration (NMPA) [1] Group 1: Product Information - HRS-5965 capsule is a complement factor B inhibitor designed to suppress complement-mediated hemolytic reactions, thereby increasing hemoglobin levels [1] - The condition targeted by HRS-5965, Paroxysmal Nocturnal Hemoglobinuria (PNH), is a rare acquired hemolytic disease characterized by the deficiency of CD55 and CD59, leading to complement-mediated intravascular hemolysis [1] Group 2: Market Context - PNH has a low incidence/prevalence rate and has been included in the National "First Batch of Rare Diseases Directory" [1]