Recently, Hengrui Pharmaceuticals' subsidiary Shandong Shengdi Pharmaceutical Co., Ltd. received the Certificate of Drug Registration approved for issuance by the State Drug Administration, approving the company's self-developed Hengrui Pharmaceuticals Metformin Extended-Release Tablets (I) (II) (Ruicinda®) for marketing, which, together with dietary control and exercise, is applicable to adult patients with type 2 diabetes mellitus (T2DM) who are suitable for receiving treatment with Hengrui Pharmaceuticals and Metformin, in order to improve the glycemic control of such patients. This marks the successful launch of China's first self-developed sodium-glucose cotransporter protein 2 inhibitor (SGLT2i) combined with metformin in a fixed-complex, extended-release formulation, which will bring more convenience to T2DM patients in China.

Diabetes mellitus has become the third chronic disease that seriously endangers human health after tumor and cardiovascular disease. At present, China has become the first country with diabetes, in which patients with type 2 diabetes mellitus (T2DM) have a progressive decline in islet function, accounting for more than 90% of the total number of diabetes patients. Domestic guidelines recommend metformin as the first-line drug for T2DM patients, and if blood glucose is not reached with metformin treatment alone, it should be combined with other glucose-lowering drugs, such as SGLT2i, for second-line treatment. In addition, patients with T2DM are often combined with multiple cardiovascular risk factors, thus affecting their prognosis. Therefore, timely and rational combination of glucose-lowering drugs with different mechanisms of action is crucial for early glycemic targeting and long-term maintenance as well as improving patients' quality of life.

Hengrui Pharmaceuticals independently developed the first SGLT2i in China, which is a new type of oral hypoglycemic drug with cardiorenal protective effect. Metformin can reduce hepatic glucose production, delay the absorption of glucose in the small intestine, and increase the uptake and utilization of glucose in peripheral tissues and improve insulin sensitivity. The approved specifications of Henggelin Metformin Extended-Release Tablets (I)(II) are 5 mg/500 mg and 5 mg/1000 mg, which can cover multiple pathophysiological mechanisms and multiple targets through complementary mechanisms, combining hypoglycemia and cardio-protection, with a good safety profile, and compared with the free combination of the two single drugs, the compound extended-release preparation can simplify the hypoglycemic regimen by decreasing the number of tablets to be taken, which is conducive to improving the patient's It is conducive to improving patients' adherence to treatment.

The approval of Henggelin Metformin Extended-Release Tablets(I)(II) is mainly based on the results of the phase III clinical study and two phase I studies on the combination of Henggelin and metformin in the treatment of T2DM.

The Phase III results showed that after 24 weeks of treatment, compared with the metformin single-agent group, the glycated blood glucose levels in the hengigliflozin 5 mg combined with metformin group ("hengigliflozin 5 mg combination group"), the hengigliflozin 10 mg combined with metformin group ("hengigliflozin 10 mg combination group "The glycosylated hemoglobin (HbA1c) of patients with high baseline (HbA1c ≥8.5%) decreased by 0.76% and 0.80%, respectively; the HbA1c of patients with high baseline (HbA1c ≥8.5%) decreased by 0.88% and 0.97%, respectively; the fasting glucose decreased by 1.72 mmol/L and 1.89 mmol/L, respectively; and the 2-h postprandial glucose decreased by 2.85 mmol/L and 2.73 mmol/L, respectively. /Extending the observation period to 52 weeks, the HbA1c of the Hengglitazin 5 mg and 10 mg combination groups decreased by 1.11% and 0.94%, respectively, compared with the baseline, and the effects on fasting glucose and postprandial glucose were also similar, suggesting that Hengglitazin in combination with metformin had a lasting and stable effect on blood glucose. In addition, the study data showed that Henggelin combined with metformin treatment can significantly reduce systolic blood pressure, diastolic blood pressure and body weight in T2DM patients.

The results of two Phase I studies showed that multiple oral doses of Hengelergine Metformin Extended-Release Tablets (I)(II) did not accumulate significantly in the body, had a favorable safety profile in healthy subjects, and that there was no clinically meaningful effect of food on the absorption of Hengelergine Metformin Extended-Release Tablets (I)(II).

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