Hengrui Pharmaceutical (01276) approved for marketing, a Class 1 therapeutic biological product, the self-developed suldi insulin injection

Zhitongcaijing · 2d ago

Zhitong Finance App News, Hengrui Pharmaceutical (01276) announced that recently, the company received a notice from the State Drug Administration to approve the marketing of the company's self-developed class 1 therapeutic biological product called sultiinsulin injection. This product is the first self-developed long-term insulin analogue in China.

Suldi insulin injection is a basic long-term insulin independently developed by the company. It has the advantages of stable efficacy, long maintenance of efficacy, and low risk of nocturnal hypoglycemia. The approval was mainly based on two key phase III clinical trials with sultiinsulin (R&D code: INS068) to treat adult T2DM patients: the INS068-301 study and the INS068-302 study. Results showed that in Chinese T2DM patients with two different treatment backgrounds (poor glycemic control of basic insulin or oral hypoglycemic agents), sultiinsulin showed a curative effect comparable to insulin glargine overall in controlling blood sugar, and the risk of nocturnal hypoglycemia was lower than insulin glargine.

Similar products have now been approved for marketing worldwide, such as Novo Nordisk's Tresiba® insulin (Tresiba®) and Sanofi's insulin glargine (Toujeo®). According to the EvaluatePharma database, total global sales of Tresiba® and Toujeo® in 2025 were approximately US$3.345 billion. Up to now, the total R&D investment for projects related to suldi insulin injections is approximately RMB 544.3 million (unaudited).