Cigliptin tablets, a 4-class generic drug of Zhengda Tianqing, was approved by the State Food and drug administration

I on February 27, the official website of the State Food and drug administration showed that the 4 generic drugs of Zhengda Tianqing, "xigliptin phosphate tablets" (acceptance No.: cyhs1700378), were approved by the State Food and drug administration, and successfully obtained the first domestic imitation of xigliptin tablets and passed the consistency evaluation Sitagliptin is the first oral DPP-4 inhibitor in the world It was developed by methadone in the United States and obtained FDA in October 2006 Approved for single drug or combined use with metformin and thiazolidinedione to improve blood glucose control of type II diabetes + disease In April 2007, the compound preparation of cigliptin and metformin was approved for marketing in the United States In the second year of listing, sigletin's sales exceeded billion (US $668 million in 2007), and in the third year of listing, sigletin's sales exceeded 1 billion (US $1.4 billion in 2008) Since 2012, the sales have been stable at about 4 billion According to the financial report of MSD in 2019, sigletin achieved global sales of US $3.482 billion, down slightly from last year (global sales of US $3.686 billion in 2108) According to Zheshang Securities report, siegliptin is the largest DPP-4 product in the world, close to the sum of other products Source: in September 2009, CFDA of Zheshang securities approved cigliptin to enter the domestic market, becoming the first DPP-4 inhibitor for the treatment of type 2 diabetes in the domestic market In July 2012, CFDA approved the registration of its compound preparation in China, with the trade name of jienoda In 2017, CFDA entered the national medical insurance (class B) In 2017, the total sales volume of terminals of public medical institutions and urban retail pharmacies in China was 485 million yuan DPP-4 is still in the leading position in the global diabetes market, but in recent years, new diabetes drugs have begun to rise, and their advantages are gradually showing, especially DPP-4, GLP-1 and sglt-2, three hot target drugs In 2017, the market share of insulin accounted for about 54% of the global diabetes drug market, and the market scale of DPP-4 inhibitors was US $11.007 billion, accounting for 26% of the total market Although GLP-1 inhibitors are in a rapid growth stage, the position of DPP-4 inhibitors in the oral hypoglycemic drug market is still difficult to shake for a while Because of the huge market potential of DPP-4, the competition of domestic ddp-4 inhibitors is very fierce According to insight global new drug pool, there are 12 kinds of DPP-4 enzyme inhibitors on the market in foreign countries, among which 5 single DPP-4 enzyme inhibitors have been approved for the market, namely, sigletin, sagletin, vigletin, agliptin and ligletin At present, three generic drugs of DPP-4 inhibitors have been approved for marketing in China They are sagletin of Jiangsu aosaikang, vigletin of hausen and Qilu, and aglitta of Yabao pharmaceutical After being approved, Zhengda Tianqing will successfully take the first generic drug of sagletin in China and become the fourth domestic DPP-4 inhibitor It is worth noting that insight database shows that at present, 8 domestic enterprises have applied for listing of cigliptin according to generic drugs category 3 or 4, another 7 enterprises have been approved for clinical trials, 6 enterprises are carrying out clinical trials, and the overall competition will be more intense in the future.