Hengrui Pharmaceutical (600276.SH): Suldi insulin injection approved for marketing. This product is the first self-developed long-term insulin analogue in China

Zhitong Financial App News, Hengrui Pharmaceutical (600276.SH) issued an announcement. 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 to treat type 2 diabetes (T2DM) in adults. This product is the first self-developed long-acting 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) for the treatment of 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 with 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.