HRS-5965 capsules, a subsidiary of Hengrui Pharmaceutical (600276.SH), will be included in the priority review process

Zhitongcaijing · 11/03/2025 09:01

Zhitong Finance App News, Hengrui Pharmaceutical (600276.SH) issued an announcement. Recently, the HRS-5965 capsules of the company's subsidiary Chengdu Shengdi Pharmaceutical Co., Ltd. were included in the publication list of priority review varieties by the Drug Evaluation Center of the State Drug Administration. The publicity period is 7 days.

Proposed Indications (or Functional Indications): Treating adult patients with paroxysmal nocturnal hemoglobinuria who have not previously been treated with complement inhibitors. <突破性治疗药物审评工作程序 (试行) >Reason for priority review: After review, this application complies with the relevant requirements of the “Administrative Measures on Drug Registration” and the “Notice of the State Drug Administration on Issuance of the Three Documents” (No. 82 of 2020), and it was agreed that “(1) pharmaceuticals in urgent clinical need, innovative drugs and improved new drugs for the prevention and treatment of diseases such as major infectious diseases and rare diseases” will be included in the priority review and approval process according to the scope of priority review.