恒瑞医药：创新药富马酸立康可泮胶囊用于血红蛋白尿症适应症上市申请获受理

Core Viewpoint - Heng Rui Medicine's subsidiary Chengdu Shengdi Pharmaceutical has received a notice from the National Medical Products Administration regarding the acceptance of its drug application for HRS-5965 capsules, aimed at treating adult patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who have not previously received complement inhibitor therapy [1] Group 1: Drug Development and Clinical Trials - The application for HRS-5965 is based on a key study (HRS-5965-301) evaluating the efficacy of HRS-5965 capsules compared to eculizumab in PNH patients who have not previously received complement inhibitor therapy [1] - The phase III clinical trial involved 76 patients and was conducted across 13 centers in China, led by prominent researchers from the Chinese Academy of Medical Sciences [1] - The total research and development investment for HRS-5965 capsules has reached approximately 218 million yuan [1]