Dongyang Pharmaceutical (06887): Toku Insulin Injection obtained marketing approval from the National Drug Administration (NMPA)

According to the Zhitong Finance App, Dongyangyang Pharmaceutical (06887) issued an announcement. The Tokugu insulin injection independently developed by the group was officially approved for listing by the National Drug Administration (NMPA), covering the two specifications of refills and pre-filled injection pens.

Tokutani insulin injection is a fourth-generation long-acting basic insulin analog, and its unique molecular structure and mechanism of action give it excellent clinical performance. Its core clinical advantage is: (1) The half-life is about 25 hours, and the duration of action exceeds 42 hours. Once a day administration can cover basic insulin requirements throughout the day. (2) The hypoglycemic curve is stable. The blood sugar variability is only about 1/4 of insulin glargine, and there is very little fluctuation in blood concentration after reaching steady state. (3) The incidence of confirmed hypoglycemia and nocturnal hypoglycemia is lower than insulin glargine, which is statistically significant. Thanks to its ultra-long-lasting pharmacokinetic characteristics, Tokugai insulin injections can be administered at any time of the day without a strict fixed injection time, greatly improving patients' compliance and flexibility.

With the approval of Tokugu insulin injections for marketing, the group has increased the number of insulin products approved in the Chinese market to 6, creating a full range of insulin product matrices covering the second to fourth generation, covering the three major clinical application scenarios of basic, meal time and premixing.

In terms of research and pipeline, the Group's Tokumendong double insulin injection is already in the marketing registration review stage. The innovative drug HEC-151, an ultra-long-lasting insulin weekly formulation, has entered phase I clinical trials. In the future, it will form a multi-level product tier of “Japanese formulation-weekly formulation-compound formulation” with the marketed products to achieve continuous iterative upgrading of the insulin product pipeline.

In terms of internationalization, the group's self-developed glycine insulin injection obtained an approval letter from the US Food and Drug Administration at the end of April 2026, making it the fourth glargine insulin product to be marketed in the US. At the same time, the company became the first Chinese pharmaceutical company to market insulin glargine in the US market. In the future, the Group will continue to promote overseas registration of various insulin products such as Mendong insulin and Tokugai insulin, continue to promote the global layout of insulin products, expand the international market share, enhance the international operation capability and brand influence of enterprises, and promote insulin products independently developed by China to the world, benefiting diabetics around the world.