CFDA drug listing approval in the first half of 2014

In the first half of 2014, compared with the same period of the past two years, the number of CFDA drugs approved for listing has decreased, and the number of traditional Chinese medicine and biological products is relatively stable: according to the statistics of Insight China Pharma data database of dingxiangyuan, in the first half of this year, CFDA approved 238 drug listing applications (calculated by acceptance number, excluding reexamination, the same below) On the whole, the number of approvals has decreased compared with the same period of the past two years, but the fluctuation is not large Among them, the reduced part is concentrated in chemical medicine, while traditional Chinese medicine and biological products are maintained in a relatively stable state 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 the year, CFDA approved 211 applications for new chemical drugs, a decrease compared with the same period in the past two years, but a slight increase in the number of new chemical drugs approved See the following figure for details: 1 Approval of new drug marketing: (1) moroninazole, the first new drug of class 1.1 in Haosen, Jiangsu Province, attracted attention: according to the Insight China Pharma data database of DXY, in the first half of this year, two new chemical drugs of class 1.1 were approved for production, which was the same as that of the same period last year They are respectively morpholinidazole (API and injection) from Haosen, Jiangsu, adefovir dipivoxil from Fangsheng, Hunan and Warner, and adefovir dipivoxil tablets from Erye, Suzhou The specific data are as follows: Table 1 Chemical drugs of category 1.1 approved for production in the first half of 2014 (data from the insight database of DXY): among them, adefovir dipivoxil has many domestic manufacturers, and this category 1.1 actually has some disadvantages But Jiangsu Haosen's morpholinidazole is worth looking forward to Morpholinidazole is the first new generation of nitroimidazole antibacterial drug with independent intellectual property rights in China, which is independently developed by Jiangsu Haosen According to the information released by hausen, compared with similar products on the market, it has the characteristics of strong antibacterial activity, good tolerance and high safety This is also the first 1.1 new drug variety approved by Jiangsu Haosen so far The research and development of morpholinidazole lasted for more than ten years Jiangsu hausen started the research on project approval of morpholinidazole in 2002, applied for clinical application in April 2005, and obtained the clinical approval document in August of the same year The speed is amazing Since then, it has been in the clinical trial stage Morpholinidazole is evaluated according to the special approved varieties, and it is also a national "major new drug creation project" It was declared to be listed in July 2011, and was approved by the end of February this year In May, it was officially put into production and listed, with the commodity name of mylinda In the first half of the year, three varieties of hausen were approved for marketing, and both innovative drugs and generic drugs have achieved a lot The specific data are as follows: Table 2 Varieties approved for production by Jiangsu Haosen in the first half of 2014 (data from insight data of DXY): (2) sofatone of class 3.1 new drug Wuhan Qirui was approved for the first time in China: according to insight China Pharma of DXY According to data base statistics, in the first half of the year, CFDA approved a total of 41 applications for listing of chemical drugs of category 3.1, involving 21 varieties (including APIs) Among them, only Wuhan Qirui's sofacone (API and dry suspension) is listed for the first time in China Sofacone is mainly used for the treatment of acute gastritis and acute attack of chronic gastritis, which is the only first imitated product approved by Wuhan Qirui so far The commodity name of sofacone dry suspension is ruilang 2 The number of approved generic drugs for listing has been decreasing year by year, and enfexite of Chengdu shengnuo is the first one in China: in the first half of the year, CFDA approved 109 applications for listing of chemical generic drugs Compared with the same period of the past two years, there has been a decrease According to the Insight China Pharma data database of dingxiangyuan, from 2010 to now, the approval amount of chemical generic drugs has been decreasing year by year While the State Food and Drug Administration encourages and supports drug innovation through a series of policies and measures, it also puts forward higher requirements for the quality and imitation level of generic drugs, and strives to improve the phenomenon of repeated application of generic drugs and waste of resources In addition, among the six generic drugs approved for listing in the first half of the year, Chengdu shengnuo biopharmaceutical Co., Ltd is the first one in China to imitate enflucetin for AIDS drug injection Enfwetide is the first HIV fusion inhibitor in the world, which is used to treat chronic human immunodeficiency virus (HIV) infection in adults and children over 6 years old It is an important drug in the field of HIV treatment It was first listed in the United States by Roche in March 2013, and then it has been listed in many countries around the world Roche obtained import approval in December 2005, and enfoviride began to enter the Chinese market Chengdu shengnuo was approved as the first domestic enterprise to be listed by enflutide (API 3.1, preparation 6) 3 Three imported varieties (gadolinitol injection, bemitarine sodium injection and sinakasai hydrochloride tablets) are approved for import for the first time in China: in the first half of the year, CFDA approved 22 drug import applications involving 11 varieties Compared with the same period of the past two years, there has been a decrease Among them, Bracco's MR contrast agent gadolinitol injection, laboratorios farmaceuticos Rovi, S.A.'s antithrombotic drug bemitarin sodium injection, and kylin Co., Ltd.'s sinakasai hydrochloride tablet are the first approved products in China 2、 According to the statistics of Insight China Pharma data database of DXY, in the first half of the year, CFDA approved 16 applications for the listing of traditional Chinese medicine, which was almost the same as that of the same period last year (13 applications) Six of them are new drugs and 10 are supplementary applications The data of new Chinese medicine approved for marketing in the first half of 2014 are as follows: Table 3 New Chinese medicine approved for marketing in the first half of 2014 (data from insight database of dingxiangyuan): 3 CFDA approved 11 applications for listing biological products in the first half of 2014, but no imports: according to insight China Pharma data of dingxiangyuan According to database statistics, in the first half of the year, CFDA approved 11 applications for listing biological products, including 5 supplementary applications and 6 new drug applications Compared with the same period last year, it is relatively stable Unfortunately, no biological products were approved for import in the first half of this year Data of new biological products approved for marketing are as follows: Table 4 New biological products approved for production in the first half of 2014 (data from insight database of dingxiangyuan):