Core Viewpoint - Chengdu Shengdi Pharmaceutical, a subsidiary of Hengrui Medicine, has announced that its HRS-5965 capsules are proposed to be included in the priority review list by the National Medical Products Administration (NMPA) of China, indicating a significant step towards potential market approval for a treatment targeting paroxysmal nocturnal hemoglobinuria in adults who have not previously received complement inhibitors [1] Drug Information - Drug Name: HRS-5965 Capsules [1] - Dosage Form: Capsule [1] - Applicant: Chengdu Shengdi Pharmaceutical Co., Ltd. [1] - Proposed Indication: Treatment for adult patients with paroxysmal nocturnal hemoglobinuria who have not previously received complement inhibitor therapy [1] Priority Review Justification - The application meets the requirements outlined in the "Drug Registration Management Measures" and the announcement regarding the "Review Procedures for Breakthrough Therapy Drugs" issued by the NMPA [1] - The drug is categorized under priority review for "clinically urgent shortage drugs, innovative drugs, and modified new drugs for the prevention and treatment of major infectious diseases and rare diseases" [1]