News from the Beijing News (Reporter Zhang Zhaohui) On March 2, Sihuan Pharmaceutical announced that its non-wholly-owned subsidiary Huisheng biological product Jiagliflozin new drug marketing application has been accepted by the State Food and Drug Administration, this is the second time A domestic class 1 innovative drug SGLT-2 inhibitor that has been applied for marketing in China and has been accepted.
Jaggliflozin is a sodium-glucose co-transporter 2 (SGLT-2) inhibitor, which inhibits SGLT-2 and reduces the reabsorption of glucose in renal tubules, thereby increasing urinary glucose excretion and achieving The effect of lowering blood sugar levels. SGLT-2 inhibitor is a new type of oral hypoglycemic drug that is highly recommended internationally for the treatment of patients with type 2 diabetes.
Clinical data show that gaggliflozin not only has a significant hypoglycemic effect, the reduction of glycosylated hemoglobin is -1.4% compared with the baseline; it also has multiple benefits such as lowering blood pressure, weight loss, and improving blood lipids. Low blood sugar risk and good overall safety profile. Compared with the Phase III clinical data results of similar products that have been marketed, gaggliflozin showed similar or even better results.
At present, the SGLT-2 inhibitor products on the market in China include four imported original drugs and one domestic drug, namely Epagliflozin (Merck & Co.) and Empagliflozin (Boehringer Ingelheim). ), Canagliflozin (Johnson & Johnson), Dapagliflozin (AstraZeneca), Henggliflozin (Hengrui Medicine). According to IQVIA data, in 2021, the domestic sales of SGLT-2 inhibitor products will be RMB 2.393 billion.
Sihuan Pharmaceutical said that as a class 1 hypoglycemic innovative drug independently developed by the group and reached the end point of Phase III clinical trials, gaggliflozin has global rights and interests, including patents in China, the United States, Europe, Japan and South Korea right. The acceptance of the listing application for canagliflozin marks the Group’s breakthrough in the field of original research and innovative drugs for the treatment of diabetes.
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