Hengrui Pharmaceutical (01276): HRS9531 injection and HRS-5817 injection obtained drug clinical trial approval notices

Zhitong Finance App News, Hengrui Pharmaceutical (01276) issued an announcement. Recently, Fujian Shengdi Pharmaceutical Co., Ltd., a subsidiary of Jiangsu Hengrui Pharmaceutical Co., Ltd. (hereinafter referred to as the “Company”), received approval from the State Drug Administration (hereinafter referred to as the “State Drug Administration”) to issue a “Drug Clinical Trial Approval Notice” for HRS9531 injection and HRS-5817 injection, which will conduct clinical trials in the near future.

RS9531 injection is a novel dual agonist targeting glucagon-like peptide-1 receptor (GLP-1R) and glucose-dependent insulin-stimulating peptide receptor (GIPR) with HRS9531 as the main active ingredient. It can regulate glycolipid metabolism, suppress appetite, and enhance insulin sensitivity in the body, thereby improving blood sugar and weight loss. Currently, for weight loss indications, only Eli Lilly's terpotide injection (trade name: ZEPBOUND) was approved for marketing in the US in November 2023, and in China (trade name: Mu Fengda) in July 2024. According to the EvaluatePharma database, ZEPBOUND's total global sales in 2024 are approximately US$4.926 billion. Up to now, the total R&D investment for HRS9531 related projects is about RMB 518.54 million.

HRS-5817 injection is a class 1 chemical drug developed independently. Preclinical data showed that HRS 5817 can exert weight loss effects in obese animal models and is safe. According to inquiries, there are currently no drugs with the same target approved for marketing at home or abroad. Up to now, HRS-5817 injection has invested about 24.89 million yuan in R&D.