Jiangsu Hengrui Pharmaceuticals (01276): The application for marketing approval of Sucranolide insulin analog injection has been accepted by the National Medical Products Administration.

Jiangsu Hengrui Pharmaceuticals (01276) announced that recently, Jiangsu Hengrui Pharmaceuticals Co., Ltd. (hereinafter referred to as the "Company") received a "Notice of Acceptance" issued by the National Medical Products Administration (hereinafter referred to as the "NMPA") for the listing application of Shudi Insulin Degludec/Liraglutide Injection. This application for listing is based on two pivotal phase III clinical studies of Shudi Insulin Degludec/Liraglutide Injection (research code: HR17031) conducted in adult patients with type 2 diabetes mellitus (T2DM). The two studies were multicenter, randomized, open-label, positive drug-controlled parallel trials (research codes HR17031-301, HR17031-302). The studies evaluated the efficacy and safety of Shudi Insulin Degludec/Liraglutide Injection compared to the control drugs in T2DM patients with inadequate blood sugar control on oral antidiabetic drugs or basal insulin therapy. The HR17031-301 study was led by Professor Ji Linong from Peking University People's Hospital, involving 54 centers nationwide, with 401 subjects randomized; the HR17031-302 study was led by Professor Chen Liming from Zhu Xianyi Memorial Hospital of Tianjin Medical University, involving 65 centers nationwide, with 393 subjects randomized. The results of both studies showed that Shudi Insulin Degludec/Liraglutide Injection significantly outperformed the control group in the primary endpoints and demonstrated good long-term safety and tolerability in patients with type 2 diabetes. Shudi Insulin Degludec/Liraglutide Injection is a fixed-ratio combination formulation developed independently by the Company, composed of a long-acting basal insulin analog and a glucagon-like peptide-1 receptor agonist. For the treatment of type 2 diabetes, similar drugs have been approved for sale globally, including Xultophy100/3.6 from Novo Nordisk and Soliqua100/33 from Sanofi. According to data from EvaluatePharma database, the global sales of similar drugs in 2025 were approximately $1.018 billion. As of now, the accumulated research and development investment in Shudi Insulin Degludec/Liraglutide Injection project is around 330 million yuan (unaudited).