Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHSE: 600276) has announced that its independently developed Class 1 therapeutic biological product, Shudi Insulin Injection, has been approved for marketing by the National Medical Products Administration. The medication is indicated for the treatment of adult patients with type 2 diabetes mellitus (T2DM).

This product represents the first long-acting insulin analog independently developed in China. Shudi Insulin Injection is a basal long-acting insulin developed by the company, offering advantages such as a stable onset of action, prolonged duration of effect, and a low risk of nocturnal hypoglycemia.

The approval is primarily based on two pivotal Phase 3 clinical trials, INS068-301 and INS068-302, which evaluated Shudi Insulin (development code: INS068) in adult T2DM patients. The results demonstrated that in Chinese T2DM patients with inadequate glycemic control on either basal insulin or oral antidiabetic drugs, Shudi Insulin showed overall comparable efficacy to insulin glargine in terms of blood glucose control, while carrying a lower risk of nocturnal hypoglycemia.