On January 12, CSPC Pharmaceutical Group (1093.HK) announced that its marketing application for pruluglitin metformin extended-release tablets (hereinafter referred to as "the product") has been accepted by the National Medical Products Administration of the People's Republic of China (hereinafter referred to as "NMPA")
This product is a combination sustained-release formulation of our Group's Class 1 innovative drug prulugliptin and metformin hydrochloride. It is being submitted for registration under Chemical Drug Registration Classification 2.3, with the proposed indication being (for adult patients with type 2 diabetes mellitus ( T2DM ): this product, in conjunction with diet and exercise therapy, is indicated for patients whose blood sugar is not adequately controlled by metformin monotherapy or who are currently receiving combination therapy with prulugliptin and metformin). Prulugliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor. By inhibiting DPP-4, it increases the level of endogenous active GLP -1, thereby increasing glucose-stimulated insulin secretion and enhancing the inhibitory effect of glucose on glucagon secretion , thus improving hyperglycemia. Metformin is a biguanide drug that reduces hepatic glycogen production, inhibits intestinal glucose absorption, and improves insulin sensitivity by increasing glucose uptake and utilization by peripheral tissues.
Phase III clinical newly treated type 2 diabetes mellitus (T2DM ) patients and those with T2DM whose glycemic control was inadequate with metformin monotherapy demonstrated the efficacy and safety of prulugliptin. Compared to metformin monotherapy, prulugliptin in combination with metformin provided a significant and sustained hypoglycemic effect with a lower incidence of hypoglycemia and a good safety profile. Furthermore , the product has a low likelihood of interactions with other drugs, and no dose adjustment is required for patients with mild to moderate renal impairment. Compared to the combination of two monotherapy formulations, this combination simplifies treatment regimens, significantly improves patient adherence, and thus more effectively controls glycemia.
Currently, the Group is actively advancing the clinical development of a three-drug combination formulation consisting of pruluglitin, dapagliflozin, and metformin hydrochloride, with the aim of benefiting more patients.

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