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’The API Empagliflozin Receives Marketing Authorization
Release time:
2024-06-20 09:15
Source:
Recently, the API Empagliflozin (Y20220001228) held by Jiudian HongYang has been officially approved by CDE and its registration status has been successfully changed to "A".
It is a highly selective inhibitor of sodium-glucose cotransporter-2 (SGLT2), which is mainly used to improve glycemic control in patients with type 2 diabetes mellitus. It possesses a unique insulin-independent glucose-lowering mechanism, i.e., by reducing glucose reabsorption in the kidneys, lowering the renal glucose threshold, and facilitating the direct excretion of glucose from the urine, thereby lowering blood glucose levels, making this class of drugs a breakthrough in the conventional treatment of diabetes mellitus. In addition to its clear glucose-lowering effect, Empagliflozin can also reduce the risk of cardiovascular events in diabetic patients as well as delay the progression of nephropathy, and it is the world's first type II diabetes drug to reduce the risk of cardiovascular death as confirmed by a large cardiovascular outcome study, and these two indications are expected to be the future growth drivers of Empagliflozin. At the same time, Empagliflozin also brings the additional benefits of weight loss, lower blood pressure, and lower uric acid.
Data show that the sales of Empagliflozin formulation in 2022 is about 610 million dollars. The successful approval of Empagliflozin API will further improve the core competitiveness of Jiudian Hongyang, build up the company's advantageous position, and help the company to develop a broader market. Jiudian Hongyang will also continue to deepen the strategic depth of the R&D industry chain, promote the high-quality development of the APIs and excipients industry, and continue to plow deeper in the field of diabetes, laying a solid foundation for future market promotion.
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