China's National Medical Products Administration (NMPA) has approved insulin sudelidec injection — marketed by Jiangsu Hengrui Pharmaceuticals (HKEX: 01276) — for the treatment of adults with type 2 diabetes mellitus (T2DM), marking the first long-acting basal insulin analog independently developed in China to reach the market. The product, developed under the code INS068, is registered as a Class 1 therapeutic biological product and is available as a pre-filled pen injector and cartridge, each at a strength of 3 mL: 300 units.
Insulin sudelidec is a once-daily basal insulin analog administered by subcutaneous injection. It is engineered to provide a smooth, stable onset of action and extended duration of effect, with structural modifications designed to slow systemic absorption from the subcutaneous depot. Hengrui states the product carries a lower risk of nocturnal hypoglycemia compared with insulin glargine, which has been a persistent barrier to long-term insulin adherence in clinical practice.
The approval rests on two pivotal Phase III trials — INS068-301 and INS068-302 — enrolling adult patients with T2DM experiencing inadequate glycemic control on basal insulin or oral antidiabetic agents, respectively. Both studies compared insulin sudelidec with insulin glargine as the active comparator. Results presented at the European Association for the Study of Diabetes (EASD) 2025 meeting demonstrated comparable efficacy in glycemic control across both treatment settings, with a statistically lower incidence of nocturnal hypoglycemia versus insulin glargine.
As a long-acting basal insulin analog, insulin sudelidec activates the insulin receptor to promote peripheral glucose uptake via the PI3K/AKT/GLUT4 pathway and suppress hepatic gluconeogenesis. Its extended pharmacokinetic profile is attributed to structural modifications — likely involving fatty acid conjugation or amino acid substitutions — that promote albumin binding or depot formation, enabling once-daily dosing with a flatter action curve than earlier-generation analogs.