Hengrui Pharma's Self-Developed Class 1 Biologic Insulin Analogue Receives Market Approval

Stock News07-29

Hengrui Pharma (01276) has announced that it has received approval from the National Medical Products Administration for its independently developed Class 1 therapeutic biologic product, Shudi Insulin Injection. This marks China's first domestically developed long-acting insulin analogue.

The product is a basal long-acting insulin developed by the company, characterized by a stable onset of action, extended duration of efficacy, and a low risk of nocturnal hypoglycemia. The approval is primarily based on two pivotal Phase III clinical trials (INS068-301 and INS068-302) evaluating the treatment of adult type 2 diabetes mellitus (T2DM) patients. The results indicated that in Chinese T2DM patients with inadequate glycemic control on either basal insulin or oral antidiabetic drugs, Shudi Insulin demonstrated comparable overall efficacy in blood glucose management to insulin glargine, while exhibiting a lower risk of nocturnal hypoglycemia.

Globally, similar products have already been approved, including Novo Nordisk's insulin degludec (Tresiba®) and Sanofi's insulin glargine (Toujeo®). According to data from the EvaluatePharma database, combined global sales of Tresiba® and Toujeo® in 2025 were approximately $3.345 billion. As of the current date, the cumulative research and development investment in the Shudi Insulin Injection project totals approximately RMB 544.3 million (unaudited).

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According to data from the EvaluatePharma database, combined global sales of Tresiba® and Toujeo® in 2025 were approximately $3.345 billion. 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This marks China's first domestically developed long-acting insulin analogue.The product is a basal long-acting insulin developed by the company, characterized by a stable onset of action, extended duration of efficacy, and a low risk of nocturnal hypoglycemia. The approval is primarily based on two pivotal Phase III clinical trials (INS068-301 and INS068-302) evaluating the treatment of adult type 2 diabetes mellitus (T2DM) patients. The results indicated that in Chinese T2DM patients with inadequate glycemic control on either basal insulin or oral antidiabetic drugs, Shudi Insulin demonstrated comparable overall efficacy in blood glucose management to insulin glargine, while exhibiting a lower risk of nocturnal hypoglycemia.Globally, similar products have already been approved, including Novo Nordisk's insulin degludec (Tresiba®) and Sanofi's insulin glargine (Toujeo®). According to data from the EvaluatePharma database, combined global sales of Tresiba® and Toujeo® in 2025 were approximately $3.345 billion. 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