Core Viewpoint - Heng Rui Medicine's subsidiary Chengdu Shengdi Pharmaceutical's HRS-5965 capsules have been proposed for inclusion in the priority review list by the National Medical Products Administration [1] Group 1: Product Information - HRS-5965 capsules are a complement factor B inhibitor designed to suppress complement-mediated hemolytic reactions and improve hemoglobin levels [1] - The target indication is Paroxysmal Nocturnal Hemoglobinuria (PNH), a rare acquired hemolytic disease characterized by the lack of CD55 and CD59, leading to complement-mediated intravascular hemolysis [1] Group 2: Market Context - PNH has been included in the national list of rare diseases due to its low incidence/prevalence [1] - Currently, the only drug approved for this indication is Novartis' Iptacopan (Fabhalta®), which is projected to have a global sales revenue of approximately $129 million in 2024 according to EvaluatePharma [1] Group 3: R&D Investment - The cumulative R&D investment for the HRS-5965 project has reached approximately 209.94 million yuan [1]