Saisheng Pharmaceutical (300485.SZ): Application for drug registration and marketing license for dapagliflozin metformin extended-release tablets was accepted

According to the Zhitong Finance App, Saisheng Pharmaceutical (300485.SZ) issued an announcement. The company's subsidiary, Beijing Saier Biopharmaceutical Co., Ltd. (hereinafter referred to as “Saier Biotech”), recently received a “Notice of Acceptance” from the State Drug Administration for the registration and marketing of drugs produced in the domestic production of dagliflozin metformin sustained-release tablets.

The combination tablet of the SGLT-2 inhibitor dagliflozin and metformin hydrochloride was developed by AstraZeneca Pharmaceuticals in the UK and approved for marketing by the FDA in 2014. In June 2023, this variety was approved for sale in China. SGLT-2 inhibitors work through a non-insulin-dependent mechanism to reduce blood sugar by reducing glucose reabsorption in the kidneys and directly excreting sugar from urine. SGLT-2 in combination with metformin showed better hypoglycemic effects and lower side effects.