Review report of CDE chemicals in 2019

Original: energy In 2019, the drug dynamic is still one of the important topics related to the national economy and people's livelihood The work of consistency evaluation has been fruitful, and the "4 + 7" volume procurement is booming The negotiation of medical insurance shows the efforts of the state in the work of drug accessibility Many policies issued by the state drive the development of the pharmaceutical industry, and the application, registration, review and approval of drugs in turn reflect the confidence of domestic pharmaceutical enterprises in the pharmaceutical industry this year So what happened to the review of chemical drugs in 2019? Insight database will analyze the application content, review conclusion, important varieties and other aspects to provide reference for you In 2019, the number of domestic chemical drug application acceptance numbers is 6106 (the data is calculated by acceptance number dimension, and the API is removed, the same below) The number of listing application acceptance numbers is 1128, slightly higher than that in 2018, significantly higher than that in 2017 (nearly three times); while the number of clinical application acceptance numbers is 829, significantly higher than that in 2018 / 2017 Overall, the number of clinical applications and listing applications is more than that in 2018 / 2017 In terms of approval, in 2019, there were 1855 acceptance numbers with review conclusions Among them, there are 834 approved clinical acceptance numbers, 427 approved production acceptance numbers and 99 approved import acceptance numbers Compared with the approved number in 2017 / 2018, the number is in a state of fluctuation, which is directly related to the change of registration approval policy and the increase of domestic review in recent years In 2019, the number of chemical application acceptance numbers is 6106, involving 1263 active ingredients and 1470 enterprises The number of acceptance numbers applied for domestic chemical drugs is 3256, accounting for 53%, and the number of acceptance numbers applied for imported chemical drugs is 2850, accounting for 47% See the figure below for detailed application content / application type From the perspective of application types in the past three years, the number of new drug acceptance numbers has gradually increased, and the growth is relatively stable, which is inseparable from the country's strong encouragement of innovation; the import acceptance number is from 2018 After a slight decline in, it began to increase significantly again, so that the domestic people could get more opportunities to use imported drugs and real good drugs; the number of existing national standard acceptance numbers tended to be stable, which to a certain extent reflected that the registration application of domestic imitated varieties was nearly stable and saturated! In terms of registration type, in 2019, the acceptance number of class 1 new drugs is 516, involving 221 varieties, including 332 domestic class 1 new drug varieties, involving 143 varieties, 184 imported class 1 new drug varieties, involving 78 varieties As a whole, the application of innovative drugs is hot! There are 176 new drug varieties of improved type 2, involving 8 varieties; 221 new drug varieties of imitated type 3, involving 123 varieties; 699 new drug varieties of imitated type 4, involving 201 varieties; in 2019, there are 271 acceptance numbers of type 5.1 and 129 acceptance numbers of type 5.2 In 2019, the number of chemical drugs approved is 1855 In terms of clinical approval, due to the influence of policies (consistency evaluation and be filing system for generic drugs in 4 categories), the number of approved clinical products decreased in 2018, only 361, and the number of approved clinical products began to increase due to tacit clinical system in 2019; in terms of approval for listing, it has gradually become stable in recent years; in terms of approval for import, the number has slightly decreased Among 1855 chemical drug acceptance numbers reviewed and approved by CDE in 2019, 1289 were domestic varieties and 566 were imported products In terms of generic drugs, there is a high degree of attention to the consistency evaluation work The number of acceptance numbers approved by CDE has reached 233, which is more than twice the number of acceptance numbers in 2018 It can be seen that even if the centralized purchase price is not friendly enough, there are still Enterprises initiating the consistency evaluation work The consistency evaluation is the general trend and becomes a stepping stone for participating in the centralized purchase to compete for the market In 2019, there are 8 domestic innovative drugs produced in batches by CDE Jiangsu hausen has contracted 2 National Class 1 new drugs (losenapeptide and flumatinib), and the company has been successfully listed, further strengthening the company's product layout; Lvgu pharmaceutical's "971" mannose sodium, which has been approved for listing conditionally for Alzheimer's treatment, has attracted attention at home and abroad; another 5 1 The new drugs are benwemod, which is used in the treatment of psoriasis of immune system by Zhonghao in Guangdong Province, coriamycin, which is used in the treatment of upper respiratory tract infection by Shanghai Tonglian, remazolam, which is used in routine gastroscopy by Hengrui in Jiangsu Province, nilapari, which is used in ovarian cancer by zaiding medicine, and rosalta, which is used in anemia of non dialysis dependent chronic kidney disease by fabergin 。 On the whole, in 2019, the number of domestic drug registration and acceptance is still high, and the investment of enterprises in drugs is still increasing At the same time, the drug audit center of the State Administration has still spent a busier year In terms of output, 8 domestic class 1 new drugs (chemicals) have been approved for listing, which is the "big year" of approval Another bright spot is the high approval of the acceptance number of consistency evaluation varieties, which to a certain extent reflects the gradual access of domestic generic drugs to the right track.