Shandong Xinhua Pharmaceutical Co, listed under 00719.HK, has announced the receipt of the Drug Registration Certificate for dapagliflozin tablets, officially approved by China's National Medical Products Administration (NMPA).

The company submitted its domestic production marketing authorization application for the drug to the NMPA's Center for Drug Evaluation (CDE) in March 2025, which was accepted for review. After a thorough evaluation process, the certificate was granted in August 2026, marking the drug's official approval for registration.

Dapagliflozin tablets are indicated for adult patients with type 2 diabetes mellitus, serving as a monotherapy to enhance glycemic control alongside diet and exercise. Additionally, the drug can be combined with metformin hydrochloride when glucose levels remain inadequately controlled with metformin alone, or used in conjunction with insulin—whether as a standalone therapy or with other oral hypoglycemic agents—when current treatments fail to achieve sufficient glycemic management.

Beyond diabetes care, the medication is also approved for adult patients with symptomatic chronic heart failure, aimed at reducing the risks of cardiovascular death, heart failure-related hospitalizations, or urgent medical visits due to the condition.

Dapagliflozin tablets are classified under Category B of the National Basic Medical Insurance, Work-Related Injury Insurance, and Maternity Insurance Drug Catalog (2025 Edition). Industry data indicates that sales of dapagliflozin tablets in Chinese public medical institutions reached approximately RMB 11.4 billion in 2025.