The R & D investment is 16 million yuan, lasting for 7 years, and the new drug shagliptin tablet of aosaikang pharmaceutical industry is approved to go on the market!

On January 21, Beijing Oriental New Star Petrochemical Engineering Co., Ltd announced that its holding subsidiary Jiangsu aosaikang Pharmaceutical Co., Ltd (hereinafter referred to as "aosaikang pharmaceutical") had recently received the approval document for drug registration (approval document No.: 2019s00011, 2019s0012) approved and issued by the State Drug Administration Saxagliptin Tablets is suitable for type 2 diabetes mellitus and belongs to DPP-4 inhibitor At present, DPP-4 inhibitors listed in China mainly include Sig Leo Dean, Shah Glenn Dean, Vee Glenn Dean, A Glenn Dean and liggliptin, all of which are imported exclusive varieties According to IMS statistics, the global diabetes drug market has reached US $80 billion and maintained an average annual growth rate of more than 15% DPP-4 inhibitors accounted for 26% of the total market in 2017 The total size of China's diabetes market is 40 billion yuan, of which 56% are oral drugs Since July 1, 2017, all five DPP-4 inhibitors have been included in the national medical insurance catalog (class B), and have been widely used in clinical practice Compared with the traditional hypoglycemic drugs, DPP-4 inhibitors have the characteristics of not increasing the risk of hypoglycemia, neutral effect on body weight, good cardiovascular safety and so on It has become one of the main programs of oral drug therapy for type 2 diabetes According to the announcement, shagliptin is the first approved generic drug in China after 7 years of research and development The acceptance time of the first production application submitted by aosaikang Pharmaceutical Co., Ltd is September 16, 2014 (Acceptance Number: cyhs1401304, cyhs1401305); after the completion of clinical bioequivalence test, the acceptance time of production application according to the new registration classification of 4 categories is June 9, 2017 (Acceptance Number: cyhs1700173, cyhs1700174) The following is the original announcement: