Dorzagliatin

The global prevalence base of diabetes continues to rise. Traditional hypoglycemic drugs are mostly designed around the pathways of insulin secretion or peripheral utilization, and there are still a large number of patients whose blood glucose control fails to meet the standard. Dorzagliatin is a glucokinase activator (GKA) with a brand-new mechanism of action. By activating glucokinase, the "sensor" of blood glucose, it simultaneously improves the insulin secretion function of islet β cells and hepatic glucose metabolism, and reshapes blood glucose homeostasis. It is clinically mainly used to improve blood glucose control in adult patients with type 2 diabetes. It can be used as monotherapy in combination with diet and exercise to control blood glucose, and can also be used in combination with metformin, providing a new option for patients with poor tolerance to metformin or insufficient therapeutic response.

As the first GKA drug approved for marketing in the world, dorzagliatin has maintained a rapid market growth momentum after its launch. In 2023, its sales in domestic sample hospitals exceeded 300 million yuan, with a year-on-year growth rate of over 400%. At present, no generic drug has been approved in the domestic market, and only the original research product is exclusively supplied. With the increasing acceptance of innovative hypoglycemic drugs by patients with type 2 diabetes, coupled with the enhanced patient accessibility after the price reduction through medical insurance negotiation, it is expected that the market size will still maintain an average annual growth rate of more than 30% in the next three years.

This variety is developed by Hua Medicine, with the original trade name of Hua Tang Ning, and the expiration date of its compound patent in China is 2033. The currently approved dosage form is tablet, with a specification of 75mg, which has been included in the Chinese Listed Medicines Catalogue as the reference listed drug. In terms of domestic API registration, the API associated with the original research enterprise has obtained the A-status registration number. A number of other domestic enterprises are carrying out R&D and declaration of dorzagliatin API, which have not been approved yet; on the preparation side, only the original research product has been approved for marketing. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for dorzagliatin. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. They comply with the regulatory requirements of the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard use needs of pharmaceutical enterprises in the process of API R&D, quality research and production.