China drug approval inventory in 2015

In 2015, when the policy changed dramatically, the declaration of generic drugs and imported drugs shrank, and CDE also made full efforts to review them How many drugs did CFDA approve this year? Which companies are up and down in this year's turmoil? According to insight - China Pharma data database, the distribution of review conclusions corresponding to new drugs, generic drugs, import and supplement applications in 9504 registration applications reviewed by CDE is as follows: according to figure 1, most of new drug applications are clinical approval, disapproval and enterprise withdrawal, of course, there are also applications for production and listing approval In the application of generic drugs, the number of approved to market is twice that of new drugs, but the number of not approved is more than that of new drugs In the application of imported drugs, in addition to the approval of clinical application, there are many applications for withdrawal and disapproval of registration Next, let's look at the specific situation of each review conclusion I Clinical approval: in 2015, there were 4477 acceptance numbers for chemical drugs, including 155 new drugs of category 1.1 and 1645 new drugs of category 3.1 1 According to the statistics of five class 1.1 new drugs approved by Jiangsu Hengrui in one year, in 2015, a total of 50 enterprises obtained class 1.1 new drug clinical approval documents, involving 63 new drug ingredient words, of which 9 enterprises have 2 or more new drug clinical approval documents in one year In addition to Guangzhou Shunjian, which specializes in 1.1 new drugs, most other enterprises are transformed from generic drugs It can be seen that in the trend of new drug R & D application, class 1.1 new drugs are no longer the favorite of a few enterprises, on the contrary, more and more enterprises begin to have the strength to participate in it In 2015, Jiangsu Hengrui obtained 5 clinical approval documents of new drugs of category 1.1, ranking first as always Shanghai Pharmaceutical Research Institute of Chinese Academy of Sciences followed closely, and obtained clinical approval documents for four new drugs Enterprises such as Jiangsu Haosen, Guangdong Dongguang, Zhejiang Haizheng and Shiyao group are not willing to be in the field of generic drugs and first generic drugs, and also reap a lot in the field of innovative drugs 2 The main work of CDE this year is the confirmatory clinical queue in which Zhengda Tianqing's first clinical approval for generic drugs ranks the first in class 3.1 clinical application review Judging from the achievements, in 2015, there were 1645 new drugs of class 3.1 approved in clinical (calculated by acceptance number) In 2015, the first approved clinical area of generic drugs (as shown in Table 2), Zhengda Tianqing ranked first, with 70 registered applications approved Nanjing Huawei Company, which has the largest number of applications, ranked second in the number of clinical approvals this year, and Jiangsu Haosen ranked third It is no surprise that Luo Xin, Qilu, Kelun and Shiyao won the first clinical application competition in this year, ranking in the top seven 2 Approval for listing: in 2015, there were 484 acceptance numbers approved for listing (including approval for production, approval for listing and approval for import), a decrease of 9.7% compared with 2014 However, only chemical drugs were reduced, and the number of approval for traditional Chinese medicine and biological products increased, especially for traditional Chinese medicine, the number of approval has tripled 1 Chemical medicine: Huabang Yingtai class 1 compound preparation was approved to be listed in 2015, and CFDA approved 310 chemical drugs to be listed in total (calculated by acceptance number) In the first half of the year, the number of approved generic drugs decreased while the number of approved new drugs and imported drugs did not change much However, in the second half of the year, the number of approved new drugs and imported chemical drugs began to decrease, down more than 25% compared with 2014 (see figure 3) In the year of drastic decrease in the number of chemical drug approvals, CFDA approved 14 chemical drug varieties to be listed in China for the first time (see Table 3) The first class of new drugs approved for marketing this year is a new compound preparation of Warburg Pincus cream, tazarotene and betamethasone The first three kinds of new drugs on the market are alprinone hydrochloride injection, arginine glutamate injection and omeprazole sodium bicarbonate capsule In addition, most of the drugs approved for marketing for the first time fall into the pockets of foreign-funded enterprises (see Table 3) 2 Traditional Chinese medicine: seven varieties of traditional Chinese medicine of Hunan Fangsheng were approved for listing In 2015, CFDA approved a total of 148 listing of traditional Chinese medicine (calculated by acceptance number) As shown in Figure 4, there was almost no approval for listing of traditional Chinese medicine from 2013 to 2014 In 2015, although the State Administration was busy with on-site inspection, verification and centralized review, it was unexpected that many varieties of traditional Chinese medicine were also approved Most of the traditional Chinese medicines approved for marketing are 8 kinds of new drugs with modified dosage form declared in 2005-2006 The approved varieties include oral solid preparations, oral liquid preparations and ointment for external use In fact, the sudden increase in the approval of traditional Chinese medicine in the first half of the year has begun to take shape By the end of the second half of the year, the number of traditional Chinese medicine approved for listing has increased by three times as much as in 2014 It's strange that in the noisy reform policies in 2015, there was no emphasis on traditional Chinese medicine and no special favorable policies Is the spring of traditional Chinese medicine coming quietly? On the one hand, the State Administration inspected the clinical trials on the spot and attached importance to the consistency evaluation of generic drugs, but on the other hand, it approved the listing of many traditional Chinese medicines We can never guess the mind of the National Bureau As shown in Table 4, Hunan Fangsheng, Hubei jingjiangyuan, Renhe pharmaceutical and other enterprises in the field of traditional Chinese medicine returned with full load in 2015: 3 Biological products: two vaccines from the Institute of medical biology of the medical college were approved for listing in 2015, and CFDA approved a total of 18 biological products to be listed (based on the acceptance number) Among them, the first two class 1 biological products approved for marketing were developed by the Institute of medical biology, Chinese Academy of Medical Sciences One is the inactivated polio vaccine of Sabin strain, which is used to prevent poliovirus infection in children The launch of the vaccine fills the gap in the field of polio vaccine production in China The other is the inactivated vaccine of human enterovirus 71 (human diploid cell) The listing of the vaccine is of great significance to reduce the incidence rate of HFMD in China III the storm of enterprise withdrawing clinical trial self inspection and verification is one of the top ten medical events in 2015 Up to now, the failure rate of registration applications in 722 announcement has reached 73% (calculated according to all self-examination and verification varieties in 722 announcement), 70.9% of which have been withdrawn, involving 488 enterprises (consolidated subsidiaries), and 1150 registration applications (including those withdrawn by extrapolation) In this large-scale campaign, the situation of enterprises withdrawn is shown in Table 5: as we all know, Zhejiang Huahai has withdrawn the most, with 19 registration applications withdrawn In addition, more than 10 acceptance numbers have been withdrawn by enterprises such as Shiyao group, Jiangsu Haosen, Jiangsu Hengrui, Shenzhen Zhijun, etc IV disapproval in 2015, CFDA issued a total of 2033 disapproved drug registration applications (calculated by acceptance number, without distinguishing application content) Among the various application types of chemical drugs, the most disapproved ones are generic drugs, with a total of 774, accounting for 25% of all generic conclusions That is to say, the disapproval rate of chemical generic drugs in this year is 25% The second is new drug application, 709 registrations are not approved, the rate of disapproval is 20.5% For foreign-funded enterprises, the situation is not very optimistic The number of imported chemicals not approved for registration is 185, and the disapproval rate is 27.9% However, 227 applications like "ten thousand essential oils" were not approved, with the disapproval rate of 16.4% Which enterprises are so "unlucky" and get the most disapproval conclusions? In the application of new drugs, Jiangsu Hengrui, which has been the number one in the application, has 39 registration applications that are not approved; Hainan rizhongtian Pharmaceutical Co., Ltd has 40 registration applications that have been killed; among foreign-funded enterprises, Novartis, Lilly, Johnson & Johnson, Pfizer, Bayer and other enterprises have not been spared How do you feel after checking the application, review and approval of drugs in 2015?