Beijing, China, April 7, 2026 – Gan & Lee Pharmaceuticals Inc. (hereinafter referred to as "Gan & Lee Pharmaceuticals", stock code: 603087.SH) announced that its wholly-owned subsidiary, Gan & Lee Pharmaceuticals Shandong Co., Ltd., recently received a drug registration certificate for sitagliptin metformin tablets (II) issued by the National Medical Products Administration (hereinafter referred to as "NMPA") (Acceptance No.: CYHS2403373, Certificate No.: 2026S00914, Drug Approval No.: H20263765).

Sitagliptin and metformin tablets (II) are a combination oral hypoglycemic agent. Each tablet contains 50 mg of sitagliptin phosphate (calculated as sitagliptin) and 850 mg of metformin hydrochloride. Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor that stimulates insulin release in a glucose-dependent manner and reduces glucagon levels by increasing the level of active incretin. Metformin inhibits hepatic gluconeogenesis, reduces glucose absorption in the small intestine, and improves peripheral tissue sensitivity to insulin by increasing glucose uptake and utilization. This product, in combination with diet and exercise therapy, is suitable for type 2 diabetes patients whose blood glucose is poorly controlled with metformin monotherapy or who are receiving combination therapy with both drugs.

According to publicly available data, sitagliptin metformin tablets (II) were approved for marketing by the European Medicines Agency in July 2008, approved by the China National Medical Products Administration for the treatment of type 2 diabetes in July 2012, and included in the National Reimbursement Drug List in 2019. According to data from Moshang, sales in secondary and above hospitals nationwide are projected to reach 346 million yuan in the first three quarters of 2025.

The approval of this drug registration certificate signifies that the product has reached the same quality level as the original drug, and according to relevant national policies, it can be considered as having passed the consistency evaluation, which will benefit its future market sales and competitiveness. Sitagliptin Metformin Tablets (II) is another oral hypoglycemic drug from Gan & Lee Pharmaceuticals, following sitagliptin phosphate tablets and empagliflozin tablets. The successful approval of this product further expands the company's main hypoglycemic product line, enriches the product structure of oral chemical hypoglycemic drugs, and provides new combination therapy options for patients with type 2 diabetes. In addition, this product has advantages such as good safety, a low incidence of hypoglycemia, and higher gastrointestinal tolerance, providing patients with a better treatment experience.

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