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    Home > Medical News > Latest Medical News > Analysis report on CDE drug review in March 2017 - drug intelligence registration and acceptance database

    Analysis report on CDE drug review in March 2017 - drug intelligence registration and acceptance database

    • Last Update: 2017-04-11
    • Source: Internet
    • Author: User
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    Highlights: in March, the number of new CDE contractors was 309, excluding reexamination (12), the same below In this month, CDE accepted 39 acceptance numbers of class 1 chemical drugs, involving 14 varieties and 13 manufacturers This month, Jiangsu Hengrui received two varieties of class 1 chemicals, shr8554 and shr-2042, respectively According to statistics, in March 2017, CDE undertook 309 new drug registration applications with acceptance number (excluding reexamination, the same below), up from 285 in February From the first quarter of 2017, the number of applications showed an overall upward trend Figure 1: the application and acceptance of chemical drugs, traditional Chinese medicine and biological products are analyzed under the acceptance of CDE drugs from July 2016 to March 2017 Figure 2 CDE's acceptance of various drug types from January to March 2017 1 CDE undertook 251 new chemical registration applications with acceptance number in March 2017 30 more than last month Figure 3 acceptance of various application types of CDE chemicals in March 2017 1 Application of new chemical drugs of category 1 CDE accepted a total of 39 acceptance numbers of new chemical drugs of category 1 in March 2017, involving 14 varieties and 13 manufacturers In the first quarter of 2017, the number of new chemical drug applications continued to be bullish, which has a great relationship with the current national policy of supporting innovative drugs It is expected that the number of new drug applications will be on the rise in the future Table 1 new chemical class 1 drugs newly undertaken in March 2017 note: as of April 1, 2017, the queue number has been severely increased by word Jiangsu Hengrui In two months of 2017, three chemical class 1 drugs were declared, namely, shr1459 (anti-tumor), shr-2042 (treatment of type II diabetes), shr8554, and one biological product for class 1 treatment shr-1316 (targeting PD-L1 McAb) According to the 2011 report of the World Health Organization, 346 million people in the world suffer from diabetes From 2010 to 2013, diabetes causes 15 to 51 million deaths every year, ranking eighth in the causes of death Diabetes generally doubles the risk, with an estimated global cost of $548 billion in 2013 China's diabetes market has been growing steadily from 2012 to 2016 According to IMS statistics, the growth rate is 47.3% from US $1.9 billion in 2012 to US $2.8 billion in 2016 The future market size of diabetes drugs in China is very considerable Table 2 declaration of Jiangsu Hengrui class 1 drugs from February to March 2017 note: as of April 1, 2017, Guangdong dongyangguang Pharmaceutical Co., Ltd has applied for 2 class 1 chemical drugs (kangdariwei sodium, hec30654acoh) in March, with a total of 7 acceptance numbers Table 3 application of chemical drugs in dongyangguang pharmaceutical industry in March 2017 note: queue No up to April 1, 2017 2 Application of chemical generic drugs In March 2017, CDE undertook a total of 51 chemical drug imitation applications with acceptance number (involving 27 varieties and 24 manufacturers), including 20 generic drugs declared according to the old 6 categories (involving 10 varieties), 20 generic drugs declared according to the new 4 categories (involving 14 varieties), and 11 generic drugs declared according to the new 3 categories (involving 8 varieties) Table 4 notes of new chemical drugs accepted by CDE in March 2017: queue No up to April 1, 2017 3 Declaration of imported chemical drugs in March 2017, CDE undertook 51 new chemical drug import registration applications, including 9 acceptance numbers of class 1 chemical drugs (involving 5 varieties), 31 Acceptance numbers of class 5.1 chemical drugs (involving 17 varieties), and 3 acceptance numbers of class 5.2 chemical drugs (involving 1 variety) Table 5 notes to newly undertaken imported chemical drugs of category 1 in March 2017: as of April 1, 2017, 2 As of March 2017, CDE has undertaken a total of 18 applications for new registration of traditional Chinese medicine, including 3 new drugs (involving 3 varieties, 2 manufacturers), 1 imported drug, 1 re registration for import, and 13 supplementary applications (involving 13 varieties, 13 manufacturers) Table 6 new Chinese medicine in March 2017 note: queue No up to April 1, 2017 3 Biological products In March 2017, CDE undertook a total of 38 applications for registration of new biological products, 18 new drugs (involving 14 varieties and 13 manufacturers), 6 imports (involving 5 varieties and 4 manufacturers), 4 re imports (involving 1 variety), and 10 supplementary applications (involving 6 varieties and 6 manufacturers) Table 7 new class 1 biological products in March 2017 note: queue number as of April 1, 2017 data source: drug intelligence registration and acceptance database note: the intellectual property rights of the above articles belong to drug intelligence network If you need to reprint, please indicate the source and 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