Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma) has obtained marketing approval from China’s National Medical Products Administration (NMPA) for insulin sudelidec injection, a Class 1 therapeutic biological product independently developed by the company.\n\nKey product features\n• Product: Insulin sudelidec injection (development code: INS068) \n• Formulations: 3 mL pre-filled pen injector and 3 mL cartridge, each containing 300 units \n• Indication: Treatment of adults with type 2 diabetes mellitus (T2DM) \n• Classification: China’s first domestically developed long-acting basal insulin analog\n\nClinical evidence\nApproval is based on two pivotal Phase III trials (INS068-301 and INS068-302) involving Chinese adults with T2DM who had inadequate glycaemic control on basal insulin or oral antidiabetic agents. Insulin sudelidec delivered glycaemic control comparable to insulin glargine while reducing the risk of nocturnal hypoglycaemia.\n\nMarket context\n• China hosts the largest diabetes population globally at about 148 million individuals, with T2DM accounting for over 90 % of cases. \n• International comparators Novo Nordisk’s Tresiba and Sanofi’s Toujeo generated combined global sales of US$3.35 billion in 2025, underscoring substantial market potential for long-acting insulins.\n\nInvestment snapshot\nHengrui Pharma’s cumulative R&D spend on insulin sudelidec stands at RMB 544.30 million (unaudited).\n\nRisk reminder\nThe company notes that post-approval production and sales remain subject to uncertainties and advises investors to exercise caution.