HENGRUI PHARMA (600276.SH) announced that its subsidiary Chengdu Shengdi Pharmaceutical Co., Ltd.'s HRS-5965 capsule has been proposed for inclusion in the priority review list by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). The public notice period is seven days.

The intended indication is for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have not previously received complement inhibitor therapy.

The priority review was granted as the application meets the requirements under the "Drug Registration Management Measures" and the NMPA's 2020 Announcement No. 82 regarding breakthrough therapy drug evaluation procedures. It qualifies under the priority review category for "innovative or improved drugs addressing clinical shortages, major infectious diseases, or rare diseases."