2017h1 domestic drug registration and application trend: Class 1 new drug blowout, East Sunshine explosion
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Last Update: 2017-07-03
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Source: Internet
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Author: User
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In the first half of 2017 (as of June 30), CDE has undertaken 2119 drug registration applications (calculated by acceptance number, the same below), down 139 from the first half of 2016 (2258) In terms of drug types, it includes 1676 chemicals, 289 biological products, 138 traditional Chinese medicines, 10 excipients, 4 in vitro diagnostic reagents and 2 combination of drugs and instruments In the first half of 2017, the registration and application of all kinds of drugs in China note: excluding diagnostic reagents, excipients and combination of medical devices In terms of application types, it includes 322 new drug applications, 215 import applications, 213 imitation applications, 1190 supplementary applications, 84 reexamination applications, 74 import re registration applications and 1 combination of medical devices More than one year after the implementation of the registration classification and priority evaluation system for new chemical drugs, the registration and application of chemical drugs in China has become increasingly rational The number of drugs registered and declared according to the old classification, such as 1.1 new drugs, 3.1 new drugs and 3.2 new drugs, is increasingly scarce Overview of chemical drug registration and application in the first half of 2017 221 class 1 new drugs were registered and applied in China in the first half of 2017, involving 80 varieties, twice as many as 37 in the same period of 2016 In terms of the number of enterprises, Hengrui has applied for 6 class 1 new drugs, showing strong R & D strength; dongyangguang has exploded, applying for 5 class 1 new drugs; among foreign pharmaceutical enterprises, Novartis and Roche have applied for 4 class 1 new drugs In the first half of 2017, there were 289 applications for registration of biological products for class 1 new drugs registered and declared in 2017h1, significantly higher than the same period in 2016, which also showed a hot prospect of domestic development of biological drugs Without considering the supplementary application, reexamination and import re registration, there are 84 new drug applications and 48 import applications In terms of drug types, there are 18 biological products for prevention and 114 biological products for treatment 2017h1 domestic registered monoclonal antibody drugs note: some drugs are not declared for the first time; import re registration, reexamination and supplementary application are not considered In the first half of 2017, there were There are 138 applications for registration of traditional Chinese medicine in total If supplementary application, reexamination and import re registration are not considered, there are 11 applications of category 6, 2 applications of category 8, 1 Application of category 5, 1 Application of category 9 and 1 Application of import The conclusion of 2017H1 registration is from the declaration of three categories of drugs, the innovation of Chinese medicine is at a standstill; the research and development of biopharmaceuticals is hot, and domestic enterprises gather together to catch up with PD-1 and other popular targets and therapies, and start with bubbles The declaration of chemical drugs gradually becomes rational, and the number of 1 kinds of innovative drugs has increased significantly With the implementation of MAH system in pilot cities, the enthusiasm of universities and scientific research institutes for new drug application will be stimulated, and the subsequent application of class 1 new drugs is expected to increase.
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