Inventory (1): number of clinical approval of drugs in the first half of 2013-2015

In the environment of the growth of biological drugs and the shrinking of the registration of imported drugs, what is the situation of drug approval in China? According to insight database statistics, in the first half of 2015, CFDA approved 465 drug clinical applications (calculated by acceptance number, excluding reexamination, the same below) On the whole, the number of clinical approval increased significantly compared with the same period of the past two years, especially the number of chemical drugs, up 39.3% compared with the same period of last year The specific situation is shown in the following figure: below, analyze the approved clinical situation of chemical medicine, traditional Chinese medicine and biological products respectively 1、 The chemical drug review accelerated, and the number of approved clinical new drugs increased by 85.2% In the first half of 2015, the number of approved clinical new drug acceptance increased by 85.2% compared with the same period last year, almost doubling Among them, more than 50% of clinical approval documents belong to class 3.1 new drugs It seems that the speed of CDE review has become the hottest topic after dinner After being pushed to the forefront in the last half year, CDE has begun to vigorously accelerate the review of new drugs 1 In the first half of 2015, there were 62 new drugs (according to the acceptance number) of class 1.1, involving 27 varieties That is to say, on average, 4-5 new drugs of category 1.1 enter the clinic every month, as shown in the figure below: the specific information of the approved clinical new drugs of category 1.1 is listed in the insight monthly drug review report, which will not be described here (focus on Insight WeChat public number, reply "year + Month" can download monthly drug review report, for example, "201507") (2) 3.1 new drugs 2015 first half year, a total of 138 3.1 new drugs approved clinical (according to the official account number), involving 52 varieties The number of class 3.1 new drug applications soared Before the 72 "heavy losses" at the end of July, the number of approved clinical drugs accounted for more than 50% of the number of approved clinical new drugs According to insight's variety screening system, in the first half of 2015, CFDA approved a total of 81 clinical applications for imported chemicals (according to the acceptance number), involving 47 varieties, slightly less than the same period last year According to insight variety screening system, there are 17 varieties of imported drugs approved for clinical use for the first time in China The clinical trials of Gilead's hepatitis C drug sofosbuvir in China bring good news to Chinese hepatitis C patients At the same time, tenofovir and enteriptinol, two AIDS compound drugs cooperated by Gilead and Johnson & Johnson, were approved for clinical use; doliravir sodium tablets, a GlaxoSmithKline AIDS drug, was also approved for clinical trials in China, and gw685698 / gsk573719 / gw642444 inhalation powder spray was also approved; In addition, bay85-3934 sodium tablet, a heart disease drug of Bayer medicine, and th-302, a soft tissue sarcoma drug of Merck xuelanuo, were approved for the first time in China In the first half of 2015, CFDA approved 63 clinical applications for biological products (based on the acceptance number), including 13 class 1 biological products and 14 imported biological products According to insight's variety screening system, the details of imported biological products approved for clinical use for the first time in China are as follows: Amgen's evolocumab (trade name repatha) competes with Sanofi alirocumab's PCSK9, which competes with Sanofi in the United States and Amgen in Europe In China, Amgen competes with Novi even faster Evolocumab has been approved twice in the first half of the year, while alirocumab is still under review Gevokizumab was used to treat gangrenous pyoderma (PG) and obtained the orphan drug qualification of FDA However, it failed to achieve the main goal of reducing ocular inflammation in its later clinical trials and suffered a stock crash The drug was approved for clinical use in China in January 2015 Romistine, a thrombopoietin (TPO) drug, was approved earlier and was approved by FDA in 2008 The drug was first developed by Kirin Pharmaceutical (Kirin later merged with Concorde fermentation), and the development rights of the United States, Europe and other countries were licensed to Amgen The drug has been approved for clinical use in China Sanofi's alpha glucosidase for injection was approved for clinical use in February, and then submitted to CFDA for listing in June Currently, Sanofi is in the review status, ranking 42 in the listing application queue.