Additional clinical approval documents for the old 6 types of imitation of agliptin

Approval document for clinical trial of drugs Jian Kang Yuan (SH: 600380): Announcement on the approval document for clinical trial of drugs obtained by coastal pharmaceutical, a wholly-owned subsidiary, recently, Shenzhen Haibin Pharmaceutical Co., Ltd (hereinafter referred to as Haibin pharmaceutical), a wholly-owned subsidiary of jiankangyuan Pharmaceutical Group Co., Ltd (hereinafter referred to as the company), has received the approval documents for clinical trials of drugs (approval No.: 2016l06501, 2016l06502) and the notice of approval opinions (approval No.: 2016l06524) approved and issued by the State Food and drug administration The relevant information is hereby announced as follows: 1 Main contents of the drug approval document 1 Name of the tablet: tablet type: tablet specification: 12.5mg application items: domestic drug registration classification: original chemical category 6 Applicant: Shenzhen Haibin Pharmaceutical Co., Ltd approval conclusion: according to the drug administration law of the people's Republic of China and relevant regulations, after examination, the product meets the relevant requirements of drug registration, and agrees to carry out human bioequivalence (be) test 2 Name of tablet: tablet type: tablet specification: 25mg application item: domestic drug registration classification: original chemical category 6 applicant: Shenzhen Haibin Pharmaceutical Co., Ltd approval conclusion: according to drug administration law of the people's Republic of China and relevant regulations, the product meets relevant requirements of drug registration after examination, It is agreed that this product is subject to human bioequivalence (be) test 3 Name of agliptin benzoate: dosage form of agliptin benzoate: API Application: domestic drug registration classification: original chemical class 3.1 applicant: Shenzhen Haibin Pharmaceutical Co., Ltd approval conclusion: according to the drug administration law of the people's Republic of China and relevant regulations, after examination, the product meets the relevant requirements of drug registration, It is agreed that this product is subject to human bioequivalence (be) test 2、 Research and development of drugs and related information agliptin benzoate tablets and raw materials have been researched and developed for more than two years They are the original chemicals 3.1 (raw materials) + the original chemicals 6 (preparations) independently developed by Haibin pharmaceutical The first time for Haibin pharmaceutical to submit the application for clinical trial of agliptin benzoate raw materials was on May 25, 2015 (acceptance No.: cxhs150078 Guangdong), and the first time for agliptin benzoate tablet production was on May 25, 2015 (acceptance No.: cyhs1500897 Guangdong, cyhs1500905 Guangdong) This product is a dipeptidyl peptidase-4 (DPP-4) inhibitor, which can control blood glucose level by protecting endogenous intestinal hypoglycemic hormone and enhancing its effect Compared with the traditional hypoglycemic drugs, this product has good hypoglycemic effect, better safety and tolerance, slight adverse reactions, and will not cause the adverse reactions of traditional hypoglycemic drugs such as weight gain, edema and hypoglycemia, while retaining the function of islet β cells Raw material product quality purification and research have technical difficulties, which can form technical barriers As of the date of this announcement, the cumulative R & D investment of agliptin benzoate tablets and raw materials is about 831200 yuan 3、 Market situation of the same kind of drugs agliptin benzoate tablets of Takeda Pharmaceutical Co., Ltd were listed in Japan in 2010 and approved to enter the Chinese market in 2013, with the trade name of "nisina" According to IMS database statistics, the total domestic sales of the product in 2015 was 7.2141 million yuan, an increase of 255.87% year on year According to the website of CDE evaluation center and Xianda database, as of the date of this announcement, a total of 25 enterprises in China have applied for the production of agliptin benzoate tablets and APIs Among them, 1 was approved for import, 12 enterprises (including Shenzhen Haibin Pharmaceutical Co., Ltd.) were approved for clinical application, 9 were not approved, and 3 were under review 4、 The approval procedure to be performed for product listing: Haibin pharmaceutical needs to carry out human bioequivalence after obtaining the formal clinical approval documents of agliptin benzoate tablets and raw materials It is preliminarily estimated that it will take two years to complete After that, Haibin pharmaceutical must submit the research results to CFDA After approval, Haibin pharmaceutical can be listed only after passing the GMP verification of raw materials.