Zhitong Finance App News, Shandong Xinhua Pharmaceutical Co., Ltd. (00719) issued an announcement. Recently, the company received the “Drug Registration Certificate” for dagliflozin tablets approved and issued by the State Drug Administration.
In March 2025, Xinhua Pharmaceutical submitted to the Drug Evaluation Center (CDE) of the China Drug Administration the registration application data for the marketing license registration of drugs produced in China and was accepted. The “Drug Registration Certificate” was obtained in August 2026. The review concluded that registration was approved.
This product is suitable for adult patients with type 2 diabetes: (1) can be treated as a single agent to improve blood sugar control on the basis of diet and exercise; (2) when metformin hydrochloride is not well controlled, it can be used in combination with metformin hydrochloride to improve blood sugar control on the basis of diet and exercise; (3) when using insulin alone or insulin in combination with oral hypoglycemic agents, it can be used in combination with insulin to improve blood sugar control on the basis of diet and exercise. This product is also suitable for adult patients with heart failure: reducing the risk of cardiovascular death, hospitalization due to heart failure, or emergency medical treatment for heart failure in adult patients with symptomatic chronic heart failure.
This product belongs to category B of the “National Catalogue of Drugs for Basic Medical Insurance, Work Injury Insurance and Maternity Insurance (2025)”. According to relevant statistics, the sales volume of dapaglinet tablets in public medical institutions in China in 2025 is approximately RMB 11.4 billion.