Inventory (2): number of clinical approval of drugs in the first half of 2013-2015

After the approved clinical quantity of new drugs doubles, is the approval of new drugs on the market the right way? The number of approved biological products has remained stable, and the number of approved chemical drugs has decreased by 22% Unexpectedly, the number of approved traditional Chinese medicine has increased six times The specific situation is shown in the following figure: below, we will analyze the approval and listing of chemical drugs, traditional Chinese medicine and biological products in the first half of this year 1、 In the first half of 2015, compared with the same period last year, the number of generic drugs approved for listing decreased by half, with the largest drop being generic drugs, down 44.6% The approval of generic drugs has been reduced, and the approval standard of generic drugs will be improved The question is, where are the 9000 acceptance numbers still in the Anda series? The number of new drugs approved and imported drugs approved is almost the same from 2013 to three times in the first half of 2014 and 2015 It can be seen that the fate of imported drugs in China has been rough in the past two years, but the situation of imported drugs may reverse after taking the ride of document 140 1 New drug (1) 1.1 new drug, Shenzhen micro core anticancer new drug, xidabantamine (epsilon) was approved to go on the market in the first half of 2015, only Shenzhen micro core 1.1 new drug, xidabantamine tablets, was approved to go on the market at the beginning of the year, which is the only 1.1 new drug approved to go on the market in the first half of 2015, and also the first drug approved to go on the market with the results of phase II clinical trials This drug for the treatment of recurrent and refractory peripheral T-cell lymphoma (PTCL) has been introduced before and will not be described in detail (concerned about Insight WeChat official account, reply to "201501" can see the introduction of Sida) (2) the 3.1 class of new drugs, first bromine sodium bromide, preempted the ophthalmic market Aupu's exclusive listing was 2015 in the first half of the year CFDA approved 40 applications for 3.1 new drugs (including the acceptance number), involving 22 varieties According to insight's variety screening system, the first class 3.1 new drugs approved for marketing in China are as follows: 2 In the first half of 2015, CFDA approved 27 applications for the listing of imported chemicals (calculated by acceptance number), involving 15 varieties, a slight increase over the same period last year According to insight's variety screening system, the chemicals approved for import for the first time in China are as follows: acitinib of Pfizer and abitrone of Xi'an Janssen were approved for listing in May Before that, class 3.1 acceptance of these two varieties was declared successively, and the approval stage was centralized from the end of July to the beginning of August According to the drug administration law, 72 These acceptances are likely to be returned to trial in a centralized manner (concerned about Insight WeChat official account, reply to "021" can see the "centralized review") two In the first half of the 2015 year of Chinese medicine, 108 approved applications of Chinese medicine approved by the CFDA (in the acceptance number), 6 times the number compared with the same period last year, 58% of which were 7, 8 drugs and modified dosage forms Previously, due to the reasons of traditional Chinese medicine injection and drug price reduction, the number of approved traditional Chinese medicine every year is very small This year, CDE has made efforts to accept 6 times of the number of approved traditional Chinese medicine in the first half of the year The approved traditional Chinese medicine does not include injections, and no traditional Chinese medicine injections are under review 3、 In the first half of 2015, CFDA approved a total of 12 biological products to be listed (calculated by acceptance number) The only class 1 biological product approved for marketing is Sabin polio inactivated vaccine The specific situation is as follows: Sabin polio inactivated vaccine is independently developed by medical biology research of Chinese Academy of Medical Sciences The vaccine contains antigens of three serotypes of polio virus and is used to prevent acute infectious diseases caused by poliovirus types I, II and III The drug fills the gap in the field of polio inactivated vaccine in China and is the first Sabin strain polio inactivated vaccine in the world