Remogliflozin

Diabetes is a chronic metabolic disease with a high incidence worldwide. As a core innovative category in the hypoglycemic field in the past decade, SGLT2 inhibitors reduce the reabsorption of glucose by renal tubules by inhibiting sodium-glucose co-transporter 2 in the kidney, and achieve hypoglycemic effect through an insulin-independent mechanism, while bringing about cardio-renal protection benefits. Remogliflozin is the first domestically developed SGLT2 inhibitor in China, which is mainly used clinically to improve blood glucose control in patients with type 2 diabetes. It can be used as a monotherapy for patients with poor blood glucose control through diet and exercise, or in combination with other hypoglycemic agents such as metformin. It is especially suitable for high-risk diabetic patients with concomitant cardiovascular diseases and chronic kidney diseases.

At present, the global market size of SGLT2 inhibitors has exceeded USD 20 billion, among which the market size in China has exceeded RMB 12 billion, with a compound annual growth rate of around 18% in the past three years. As a domestic innovative SGLT2 inhibitor, remogliflozin has achieved rapid volume growth after launch by virtue of its lower pricing and advantages in local clinical data. In 2023, its sales in domestic public medical institutions exceeded RMB 300 million. Currently, the competitive landscape of this category in China is dominated by original innovative drugs, and it has not yet been included in the national centralized procurement catalogue. With the expansion of medical insurance coverage in the future, its market growth rate is expected to further increase.

The original research enterprise of remogliflozin is Jiangsu Hengrui Medicine, with the original brand name Ruiqin. The core compound patent will expire in 2042. The currently approved main dosage form is tablet, with a specification of 1mg. This product has been included in the Reference Listed Drugs in the China Listed Drug Catalogue. As of now, the CDE API Registration Platform has not shown other remogliflozin API registration information except those associated with the original research. The only domestically approved marketed preparation of remogliflozin is the remogliflozin tablets from the original research enterprise Hengrui. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of remogliflozin impurity reference standards, covering the full-dimensional research needs including synthetic process impurities and degradation impurities. Most products are available from stock, and orders placed before 16:00 can be shipped on the same day. All products comply with the regulatory requirements of multiple systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the needs of impurity reference standards in API R&D, quality research and production processes.