Count the innovative drugs that have entered the fast lane for review and approval

In 2017 (as of September 30), CDE undertook a total of 3509 drug registration applications (calculated by acceptance number, the same below), an increase of 447 compared with the same period last year (3062), and the review and approval speed was significantly improved In terms of drug types, there are 2759 chemical drugs, 450 biological products and 235 traditional Chinese medicines (see Figure 1 for details) portant;"> portant; "> (Figure 1) According to the pharmaceutical intelligence data, of all the drug registration applications undertaken by CDE in 2017, there were 376 class 1 drugs and 2 class 1.1 drugs, which exceeded nearly half of the total number of class 1 and 1.1 drugs (201) in the same period of 2016 It can be seen that under the guidance of a series of policies such as the listing permit holder system and the priority review system, the awareness of enterprise innovation has been significantly improved, and the form of Jiangsu Hengrui Pharmaceutical Co., Ltd Now it is particularly prominent Among the 376 category 1 drugs, 20 are declared by Jiangsu Hengrui (see Figure 2 for the specific list), which is the largest number of enterprises, 19 of which are special evaluation varieties In the 19 special review varieties, shr1459, a new chemical drug of category 1, has entered the fast lane of review and approval The product entered CDE on February 13, 2017, and has been approved for clinical application on July 21, 2017, lasting less than half a year Shr1459 is a kinase inhibitor It can inhibit the activation, proliferation and survival of B cell through selective inhibition of BTK kinase, and then inhibit the growth of B cell lymphoma At the same time, inhibition of BTK can inhibit the activation of transcription factors, reduce the release of inflammatory factors, and then alleviate rheumatoid arthritis It is understood that ibrutinib is the only Btk inhibitor on the market in the world, and its global sales volume in 2016 is about 2.1 billion US dollars The internal and external efficacy of shr1459 clinical precursor declared by Hengrui is equivalent to that of ibrotinib, and the market prospect is broad In addition to Jiangsu Hengrui's shr1459 tablets, according to the data of pharmaceutical intelligence, as of September 30, there were 38 class 1 drugs accepted by CDE this year, including 28 chemical drugs and 10 biological products 18 varieties including Guangdong Zhongsheng Pharmaceutical Co., Ltd., Shanghai Institute of biological products, Shijiazhuang Yiling Pharmaceutical Co., Ltd., Sichuan Kelun Botai biological Co., Ltd., Suzhou Yasheng Pharmaceutical Co., Ltd also entered the fast lane of review and approval Among the 28 chemical drugs, 25 are new drugs, 3 are imported drugs, 10 varieties in total (see Figure 3 for the specific list) portal; "> TA: image / GIF; BA se64, 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