Gelonghui March 23 丨Hengrui Pharmaceutical (600276.SH) announced that recently, Chengdu Shengdi Pharmaceutical Co., Ltd., a subsidiary of the company, received approval from the China Drug Administration to issue a “Drug Clinical Trial Approval Notice” on HRS-5965 and will conduct clinical trials in the near future.

According to the “Drug Administration Law of the People's Republic of China” and related regulations, HRS-5965 tablets (specifications 25 mg, 100 mg) received on December 26, 2022 met the relevant requirements for drug registration and agreed to conduct clinical trials in indications related to hemolytic anemia mediated by complement participation (including paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, cold agglutinin disease, etc.).

HRS-5965 tablets may inhibit complement system-mediated hemolysis by inhibiting excessive activation of the complement system. Preclinical evidence showed that it had a significant inhibitory effect in complement-mediated hemolysis models and was safe. According to inquiries, no similar products have been approved for listing in China yet. Up to now, a total of about 40.16 million yuan has been invested in R&D projects related to the HRS-5965 film.