补体因子 B 抑制剂
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恒瑞医药:HRS-5965 胶囊拟纳入优先审评程序
Zhi Tong Cai Jing· 2025-11-03 11:10
Core Viewpoint - 恒瑞医药's subsidiary, 成都盛迪医药, has had its HRS-5965 capsule proposed for inclusion in the priority review list by the National Medical Products Administration, indicating a significant step in the drug's development process [1] Group 1: Product Development - HRS-5965 is a complement factor B inhibitor designed to treat Paroxysmal Nocturnal Hemoglobinuria (PNH), a rare acquired hemolytic disease characterized by the deficiency of CD55 and CD59, leading to complement-mediated intravascular hemolysis [1] - The drug aims to inhibit complement-mediated hemolytic reactions and improve hemoglobin levels in patients [1] Group 2: Market Context - PNH has a low incidence/prevalence and is included in the national list of rare diseases, highlighting the potential market for treatments in this area [1] - Currently, the only drug targeting the same mechanism is Novartis's Iptacopan (Fabhalta), which is projected to generate global sales of approximately $129 million in 2024 according to EvaluatePharma [1] Group 3: R&D Investment - The cumulative research and development investment for HRS-5965 has reached approximately 209.94 million yuan [1]