CSPC Group (01093): Pluragliptin, dagliptin, metformin sustained-release tablets approved for clinical trials in China

According to Zhitong Finance App, Shiyao Group (01093) issued an announcement. Plugliptin dagliflozin metformin sustained-release tablets (this product) developed by the Group has been approved by the State Drug Administration of the People's Republic of China, and clinical trials can be carried out in China.

This product is the world's first clinically approved three-drug combination preparation composed of plugliptin, dapagliflozin, and metformin hydrochloride. Pluglitin is a dipeptidyl peptidase-4 (DPP-4) inhibitor that increases endogenous active glucagon-like peptide-1 (GLP-1) levels by inhibiting DPP-4, thereby enhancing the sensitivity of beta cells and alpha cells to glucose, increasing glucose-stimulated insulin secretion, and enhancing the inhibitory effect of glucose on glucagon secretion, thereby improving hyperglycemia. Dapagliflozin is a sodium-glucose co-transporter 2 (“SGLT2”) inhibitor. By inhibiting SGLT2, it reduces reabsorption of filtered glucose, thereby promoting urinary sugar excretion. Metformin is a biguanide drug that improves glucose tolerance and reduces basal blood sugar and postprandial blood sugar in patients with type 2 diabetes.

The clinical indication approved this time is: “This product is used in combination with diet and exercise for adult type 2 diabetics with poor blood sugar control when using metformin hydrochloride alone.” The three-drug combination formulation complements the drug mechanism of action, covers multiple pathophysiological mechanisms of diabetes, can effectively control blood sugar, and has good safety and tolerability; at the same time, it can reduce the amount of medication taken, simplify the hypoglycemic plan, improve patients' compliance with treatment, and have high clinical development value. The product will provide new treatment options for type 2 diabetics and further enrich the Group's product line in the field of metabolic diseases.