Janagliflozin

For patients with type 2 diabetes, the advent of SGLT2 inhibitors has provided a brand-new path for blood glucose management that also delivers cardio-renal benefits, and gegliflozin is a representative of domestic innovation in this category of drugs. Its mechanism of action does not depend on insulin secretion. By selectively inhibiting sodium-glucose co-transporter 2, it reduces the reabsorption of glucose in primary urine by the renal tubules and promotes the excretion of excess glucose along with urine. While lowering blood glucose, it can also bring additional benefits such as weight loss and blood pressure improvement. At present, this drug is mainly used for blood glucose control in adult patients with type 2 diabetes. It can be used as a monotherapy for patients with poor control through diet and exercise, and can also be used in combination with other hypoglycemic agents such as metformin, especially suitable for the type 2 diabetes population with combined high cardio-renal risk factors.

In the domestic hypoglycemic drug market, SGLT2 inhibitors have maintained a significant growth momentum in recent years. In 2023, the overall market size had exceeded 9 billion yuan, with a compound annual growth rate of over 35%. As the first domestically developed SGLT2 inhibitor with independent intellectual property rights in China, gegliflozin, relying on its advantages of lower pricing and local clinical data, is gradually breaking the market monopoly of originator varieties. It has now been included in the National Reimbursement Drug List, and its hospital sales in the first half of 2024 increased by more than 200% year on year, with its market penetration rate rising rapidly.

Gegliflozin is independently developed by Hengrui Medicine, with the trade name Ruiqin®. The core compound patent will expire in China in 2033. The currently approved dosage form is tablet, with specifications of 100mg and 200mg. Its preparation has been included in the Catalogue of Marketed Drugs in China and is the domestic reference listed drug. In terms of active pharmaceutical ingredients (APIs), Hengrui Medicine's gegliflozin API has completed the registration of APIs, excipients and packaging materials with the Center for Drug Evaluation (CDE), with the registration number Y20220000388 and the status of A. At present, its preparations have been approved for marketing in China. (Data as of June 2025, please refer to the official website of CDE for the latest information.)

CATO can provide a full set of impurity reference standards for gegliflozin, which meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA. Most products are in regular stock, and orders placed before 16:00 can be shipped on the same day, which can fully meet the reference standard use requirements of the whole process of API R&D, quality research and production.