恒瑞医药：子公司药物HRS-5965胶囊获国家药审中心拟纳入优先审评名单

Core Insights - Chengdu Shengdi Pharmaceutical, a subsidiary of Heng Rui Medicine, has its HRS-5965 capsule proposed for inclusion in the priority review list by the National Medical Products Administration, with a public notice period of 7 days [1] Product Details - Indication: Treatment for adult patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who have not previously received complement inhibitors [2] - Reason for Priority Review: Classified as an innovative drug for rare diseases, meeting the criteria for urgently needed and scarce drugs [2] - Mechanism of Action: Complement factor B inhibitor, capable of inhibiting complement-mediated intravascular and extravascular hemolysis [2] Market Situation - Competitive Landscape: The only drug targeting the same mechanism is Novartis' Iptacopan capsule, which has been approved abroad [2] - Market Size: Novartis' product is projected to achieve global sales of approximately $129 million in 2024 [2] - R&D Investment: Cumulative R&D investment for this project is approximately 210 million yuan [2]