CFDA drug clinical approval in the first half of 2014

According to the statistics of Insight China Pharma data database of dingxiangyuan, in the first half of the year, CFDA approved a total of 314 drug clinical applications (calculated by acceptance number, excluding reexamination, the same below) In general, the number of approvals has decreased compared with the same period of the past two years, while the decrease is mainly concentrated on chemical drugs The specific situation is shown in the following figure: below, we will analyze the approved clinical situation of chemical medicine, traditional Chinese medicine and biological products in the first half of this year 1、 Compared with the same period of the past two years, the number of approved clinical drugs has decreased: in the first half of the year, CFDA approved 261 clinical drugs, of which the number of approved new drugs has increased slightly compared with the same period of last year, while the number of approved other application types has decreased compared with the same period of last year, as shown in the following figure: Now, let's take a look at the clinical approval of new chemical drugs and imports in the first half of this year 1 Clinical approval of new drugs: (1) new drugs of category 1.1: in the first half of this year, 10 new chemical drugs of category 1.1 were approved, and Hengrui accounted for two: according to the statistics of Insight China Pharma data database of DXY, in the first half of this year, 10 new chemical drugs of category 1.1 obtained clinical approval documents, which was less than that of the same period last year (15) Among these 10 varieties, Jiangsu Hengrui has two leading enterprises, namely, the anti-tumor drug cimidridi (API and tablet) and the diabetes drug furoglitazone (API and tablet) In the first half of 2014, the data of class 1.1 new drugs approved for clinical use are as follows: Table 1 Class 1.1 new drugs approved for clinical use in the first half of 2014 (data from the insight database of DXY): it is worth noting that three of them were originally listed applications, but they were not approved for marketing at last, but clinical approval documents were sent, and clinical trials need to be continued They are fluoxinib mesylate in Jiangsu hausen, butane sulfonic acid in Liaoning Lantian Pharmaceutical Co., Ltd and sucrose gel from Hebei Medical University In addition, it can be seen from the above data that most of these new chemical drugs 1.1 took about one year from entering the drug examination center to obtaining clinical approval documents (2) Class 3.1 new drugs: in the first half of the year, three new chemical drugs of class 3.1 were approved for the first time in China In the first half of the year, CFDA approved 74 clinical applications for new chemical drugs of class 3.1, an increase compared with the same period last year Due to the large number of varieties, we mainly screened out the first two approved clinical enterprises and corresponding varieties which have not been listed in China at present according to the variety screening system of Insight China Pharma data database of DXY The specific data are as follows: Table 2 The first half of 2014 approved clinical class 3.1 new drugs and their corresponding enterprises (the first two in China): 2 Import clinical approval: anti-tumor drugs are still a hot spot: in the first half of 2014, CFDA approved 81 clinical applications for import of chemical drugs (calculated by acceptance number), a decrease compared with the same period last year (105) According to the variety screening system of dingxiangyuan insight database, we screened 11 varieties that were first approved for clinical import in China in the first half of this year Among them, Bayer has 3 varieties, Novartis has 2 varieties In addition, as many as five of these 11 varieties of anti-tumor drugs are still hot research and development The specific data are as follows: Table 3 The first approved clinical imported varieties in the first half of 2014 (data from the insight database of DXY): according to the global R & D progress data of the Insight China Pharma data database of DXY, only o nyx The pharmaceutical company's kafezomi (trade name: kyrolis) was approved by FDA in July 2012 and has been listed in the United States The rest of the products have not been listed in the world It can also be seen from this that large pharmaceutical enterprises will, in general, conduct clinical research in multiple countries and regions at the same time 2、 Clinical approval of traditional Chinese medicine is relatively stable: in the first half of the year, CFDA approved a total of 9 clinical applications of traditional Chinese medicine (based on acceptance number), which is almost the same as that of the same period last year (8) Eight of them are new drugs and one is supplementary application Specific data are as follows: Table 4 Approved clinical traditional Chinese medicine in the first half of 2014 (data from the insight database of DXY): 3 In the first half of 2014, there were 4 new biological products of class 1, which were approved for clinical use, and anti-tumor monoclonal antibody drugs developed fever: according to the Insight China Pharma data of DXY According to database statistics, in the first half of the year, CFDA approved 44 clinical applications for biological products (based on acceptance number), a decrease compared with the same period last year (53) Among them, there are 4 varieties of class 1 new drugs, and 3 of them are anti-tumor monoclonal antibodies Specific data are as follows: Table 5 Class 1 new drugs of biological products approved for clinical use in the first half of 2014 (data from insight database of DXY): in recent years, the development of pharmaceutical biotechnology is rapid, and the monoclonal antibody is more popular According to the list of the world's best selling drugs released by Gen in 2013, seven of the top ten are biological products, and the most remarkable is that the top three are all McAbs (adamumumab, infliximab and rituximab) Nitorzhumab injection (trade name: taixinsheng) of Baitai bio Pharmaceutical Co., Ltd is the first humanized anti-tumor mAb in China and the third mAb approved to treat solid tumors in the world, mainly used to treat epithelial tumors in head and neck, esophagus, stomach, lung, breast, colon, rectum and other parts In fact, taixinsheng has been approved for listing in January 2008 and officially listed in June of the same year After coming into the market, Baitai continues to carry out clinical research on new indications (Note: review of China's drug declaration acceptance in the first half of 2014, http://img.dxycdn.com/drugdb/pdf/20140710/201407109636.pdf)