Coming! Hausen takes the lead in Qilu, and the heavyweight DPP-4 inhibitor is officially approved for the first time!

Recently, Jiangsu Haosen Pharmaceutical Co., Ltd.'s viagretine tablet was approved with the approval number of gjzz h20193060 Viagliptin is the second DPP-4 inhibitor on the market in the world to reduce hyperglycemia in type 2 diabetes Developed by Novartis, it was approved by the European Drug Administration (EMA) on September 26, 2007, with the trade name of galvus; later, it was approved by the Japan pharmaceutical medical device integration Agency (PMDA) on January 20, 2010; it was approved by the former CFDA in 2011, and compared with sigletin, vigletin was not approved by the FDA and could not be used for kidney and liver injury Patients should be given orally twice a day In recent years, the sales volume of wigletin has not fluctuated much, basically between us $1.1 billion and US $1.2 billion, and there is still a large amount of space in the market In 2017, the sales volume reached US $1.233 billion At present, there are only imported drugs from Novartis in China As the patent of the drug is about to expire (the patent of the drug compound expires in China on December 9, 2019), the competition for generic drugs is intensified At present, there are 21 acceptance numbers of generic drugs, among which 14 acceptance numbers are declared according to the old 6 categories, and 12 acceptance numbers have been approved for clinical application In addition, 2 acceptance numbers are hausen and Qilu According to the tracking of phase 2 (1, 2) of yaogajun, a column of yaozhi.com, hausen and Qilu have been approved before and after approval, and finally hausen has won the first formal approval of generic drugs At present, Qilu shows "issued parts" In addition, there are seven acceptance numbers registered according to the new four categories, which are under "review and approval", involving famous enterprises such as Yangzi River and Beijing Taide It is reported that the domestic diabetes market is over 50 billion yuan However, the market of DPP-4 inhibitors has opened a new round of market competition pattern with the addition of five varieties (sigletin, sagletin, vigletin, ligletin, and agliptin) to the 2017 version of the national health insurance catalog, with a promising future.