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Pharmaceutical Network September 24 recently, NMPA data show that Zhengda Tianqing Pharmaceutical Group's Kagle net tablets 4 imitation listing applications entered the "in the approval" state, if successfully approved will become the second domestic after Howson.
, Four types of generic listing applications from Colum Pharmaceuticals are also being reviewed and approved.
Figure 1: Kagle Net Tablet Registration, Zhengda Tianqing Pharmaceutical Group Source: NMPA Kaglile Net, developed by Johnson and Johnson, is the first FDA-approved SGLT-2 inhibitor and was approved in the United States in March 2013.
The drug reduces the level of glucose in the blood by inhibiting the re-absorption of glucose by the renal tube, thus achieving the effect of treating type 2 diabetes, and the drug has therapeutic effect on type 2 diabetes at all stages because it does not rely on insulin secretion and action levels.
products were approved to enter the Chinese market in September 2017 and entered the National Health Insurance Directory through health care negotiations in November 2019, limiting the use of "second-line medications".
Figure 2: Kagley net imitation listing application source: Minet MED2.0 China Drug Review Database in December 2019, Howson Pharmaceuticals' Kagle net tablet 4 type of imitation listing application was approved, won the "first imitation and first review", if Zhengda Qing successfully approved to become the second domestic, the current listing application is still in review and Colum.
meters of intranet data show that in 2019 in China's urban public hospitals, county-level public hospitals, urban community centers and township hospitals (referred to as China's public medical institutions) terminal, the market size of non-insulin-based hypoglycemic drugs has risen to 28.5 billion yuan, the last three years of growth rate of more than 15%, showing a high-speed growth trend, more than 1 billion varieties are also as high as five.
Figure 3: 2020 to date is the approval of the day-to-day pharmaceutical group listed diabetes drugs source: Midenet MID drug index comprehensive database in recent years, Zhengtianqing Pharmaceutical Group in the field of diabetes drugs continue to increase the size of China's public medical institutions terminal, the company's share of diabetes drugs from 0.15 in 2015 88% rose to 1.05% in 2019, so far in 2020 there have been shagritin tablets (the second in the country), phosphoric acid sigredin tablets (domestic first imitation) approved, currently in addition to the Kaglile net film in the approval, Engli net film 4 categories of listing applications in the review and approval.
source: NMPA official website, Minet database review data statistics as of September 23, 2020.