Jiangsu Hengrui Pharmaceuticals (01276): Recaticimab for Injection Receives Drug Clinical Trial Approval Notice

Jiangsu Hengrui Pharmaceuticals (01276) announced that recently, Guangdong Jiangsu Hengrui Pharmaceuticals Co., Ltd., a subsidiary of Jiangsu Hengrui Pharmaceuticals Co., Ltd. (hereinafter referred to as the "Company"), received a Drug Clinical Trial Approval Notice issued by the National Medical Products Administration (hereinafter referred to as the "NMPA") for Recaticimab for Injection, and will conduct clinical trials in the near future. Recaticimab for Injection is a recombinant anti-proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibody independently developed by the Company. It can inhibit the binding of PCSK9 to the low-density lipoprotein receptor (LDLR), increase the number of LDLRs capable of clearing low-density lipoprotein from the blood, thereby lowering LDL-C levels. Currently, similar drugs have been approved for marketing globally, including Amgen's evolocumab, Sanofi's alirocumab, INNOVENT BIO's tafolecimab, JUNSHI BIO's ongericimab, and AKESO's ebronucimab, among others. The Company's Recaticimab for Injection was approved for marketing in China in 2025 for adult patients with hypercholesterolemia and mixed dyslipidemia. According to the EvaluatePharma database, the global sales of the above similar products in 2025 totaled approximately US$3.987 billion. As of now, the cumulative R&D investment in Recaticimab for Injection-related projects is approximately RMB 422.20 million (unaudited).