China Resources SECCO regigrenide metformin tablets clinical approval

China Resources SECCO, a wholly-owned subsidiary of China Resources Shuanghe, obtained the approval documents for clinical trials of drugs Approval document for clinical trial of drugs: China Resources Shuanghe (SH: 600062): Announcement on the approval document for clinical trial of drugs obtained by wholly-owned subsidiary of China Resources SECCO regigrenide metformin tablets (I) and (II) recently, China Resources SECCO Pharmaceutical Co., Ltd (hereinafter referred to as "China Resources SECCO"), a wholly-owned subsidiary of China Resources Shuanghe Pharmaceutical Co., Ltd (hereinafter referred to as "the company"), has received the approval documents for clinical trials of retaglinide metformin tablets (I) and (II) approved and issued by the State Food and Drug Administration (hereinafter referred to as "the State Food and Drug Administration") Now the relevant information is announced as follows: 1 Main contents of the drug approval 2 Indications of other drug research situations: used for blood glucose control of adult type 2 diabetic patients who have been treated with a megetinide and metformin hydrochloride; It is used for blood glucose control in adult type 2 diabetic patients who are not able to control blood glucose by using a megetinide or metformin hydrochloride alone Other conditions: repaglinide is a new type of non sulfonylurea insulin secretion promoting drug By closing ATP dependent potassium channels in pancreatic β cells, it can stimulate the pancreatic secretion of insulin, specifically recover the early phase of insulin secretion, and reduce the peak of postprandial blood glucose Metformin can inhibit appetite and glucose absorption of intestinal wall, enhance glucose uptake and anaerobic digestion of peripheral tissues, inhibit lactate production caused by tissue respiration, and inhibit gluconeogenesis of liver and kidney Clinical studies have shown that the combination of repaglinide and metformin has a more significant effect of reducing HbA1c compared with the two drugs alone The effect of the combination of repaglinide and metformin on controlling HbA1c is greater than that of the combination of metformin and repaglinide alone This shows that the combination of the two has a good synergistic effect and can control blood glucose more effectively than the single drug Declaration date: April 30, 2015 As of the date of this announcement, the accumulated R & D cost of the drug registration application is about 1.71 million yuan 3、 Market situation of similar drugs: novonordiskinc is the original manufacturer of the tablets (I) and (II), and the trade name is prandimet It was approved by FDA in June 2008 According to the pharmaceutical database (PDB) of China Pharmaceutical Industry Information Center, the sales revenue of prandimet in 2014 was US $308 million; the company did not know the data of similar drugs from other manufacturers in foreign market Domestically, Jiangsu Haosen Pharmaceutical Co., Ltd.'s "Fulaidi" was first imitated and listed in 2014 The product just entered the PDB drug comprehensive database in 2015, and its market sales data has not been known 4、 According to the requirements of laws and regulations related to drug registration in China, human bioequivalence (be) test shall be carried out for drugs after obtaining the approval documents of clinical trials, and the drugs can be produced and put on the market after being approved by the drug evaluation center of the State Food and drug administration.