CSPC PHARMA (01093) announced that the marketing application for its Puluoglitin Metformin Sustained-Release Tablets has been accepted by China's National Medical Products Administration (NMPA). This product is a compound sustained-release formulation of the Group's Class 1 innovative drug Puluoglitin and Metformin Hydrochloride, submitted under chemical drug registration category 2.3, with the proposed indication for "adult patients with type 2 diabetes (T2DM): this product, in conjunction with diet and exercise therapy, is intended for use when metformin monotherapy provides inadequate control or for patients already receiving combined treatment with Puluoglitin and metformin."

Puluoglitin is a dipeptidyl peptidase-4 (DPP-4) inhibitor that works by increasing endogenous levels of active GLP-1, thereby enhancing glucose-stimulated insulin secretion and strengthening the inhibitory effect of glucose on glucagon secretion, which subsequently improves hyperglycemia. Metformin, a biguanide drug, functions by reducing hepatic glucose production, inhibiting intestinal glucose absorption, and improving insulin sensitivity through increased glucose uptake and utilization in peripheral tissues.

Phase III clinical trials conducted in both treatment-naïve T2DM patients and those with inadequate glycemic control on metformin monotherapy have confirmed the favorable efficacy and safety profile of Puluoglitin. Compared to metformin monotherapy, the combination of Puluoglitin and metformin demonstrated significant and durable glucose-lowering effects, a lower incidence of hypoglycemia, and a good safety profile.

Furthermore, this product has a low potential for drug-drug interactions, and patients with mild to moderate renal impairment do not require dose adjustments when taking it. Compared to the co-administration of two separate single-agent formulations, this fixed-dose combination simplifies the treatment regimen and significantly improves patient adherence, leading to more effective blood glucose control.

Currently, the Group is actively advancing the clinical development of a triple-drug combination formulation comprising Puluoglitin, Dapagliflozin, and Metformin Hydrochloride, aiming to benefit a broader patient population.