May 2014 CDE drug review report

Recently, the insight data team of dingxiangyuan sorted out and analyzed the registration applications of drugs accepted by CDE in May 2014, with a total number of 802 applications (calculated by acceptance number, the same below), a large increase compared with the same period of the past two years In the past five months, CDE acceptance has increased significantly this year As can be seen from Figure 1, the monthly acceptance volume of CDE in the past two years has fluctuated between 500 and 700, and only a few months exceeded this range This year, however, except for February, which was the same as the same period in the past, the number of other months exceeded 700, and even exceeded 800 in January and may However, the increased acceptance is mainly concentrated in the chemical part The following is an analysis of the acceptance and review of chemical and biological products in May 2014 （1） Acceptance and review of new drugs 1 In May, there were 187 new drug applications accepted by CDE with acceptance number, a decrease compared with 231 applications last month (1) 1 In the application for new chemical drugs of class 1, there are 19 applications for new drugs of class 1.1, involving 8 varieties, which are the same as last month, and these 8 varieties are all included in the list of special approved varieties by CDE Table 1 Among the chemical 1.1 new drug applications accepted by CDE in May 2014, PTS of Tianjin HongRi Pharmaceutical Co., Ltd is a new drug listing application, and other varieties are new drug clinical applications P-toluenesulfonamide is the first anticancer drug with high efficiency, broad spectrum, low toxicity and specific identification and staining by intratumoral injection at home and abroad The indication declared by HongRi pharmaceutical industry is central lung cancer with severe airway obstruction From Insight China Pharma Da TA database is used to query the review of p-toluenesulfonamide injection (acceptance No.: cxhs1400080), as shown in Figure 4, we can clearly see all the event records of it in CFDA and CDE so far It has been included in the NDA (new drug production application for market) review task sequence by CDE according to special approved varieties on May 29, and it is currently in the status of queuing for review As a special approved product, the evaluation of the drug will go through a green channel, and it may be able to obtain marketing license in the next two to three years In addition, in April last year, the 1.1-class chemical drug, picolamine mesylate for injection, which was declared by HongRi pharmaceutical industry for the treatment of sepsis, has been approved for clinical use and will soon receive clinical approval At the same time, the company also has generic drugs such as flupentine, aripiprazole, pramipexole, etc which are under review Among the other clinical varieties applying for new drugs of class 1.1, remazolam besylate of humanwell pharmaceutical is used for surgical anesthesia However, ramazolam toluene sulfonate of Jiangsu Hengrui has been approved for clinical use by the end of March last year, and humanwell Pharmaceutical Co., Ltd is changing toluene sulfonate into benzene sulfonate this time Wicagrel is a new antithrombotic drug of 1.1 class jointly developed by Jiangsu Weikeli and China Pharmaceutical University through the cooperation of industry, University and research It is an improvement on the best-selling drug clopidogrel (2) In May, CDE accepted a total of 130 applications for class 3.1 new drugs, involving 61 varieties, with a slight decrease compared with the previous month There are 43 applications for listing, involving 27 varieties; 87 clinical applications, involving 34 varieties Among them, zatobrofen, an anti arthritis drug of Dianhong Pharmaceutical Co., Ltd (tablet and capsule, API is declared by Nanjing Baijingyu Pharmaceutical Co., Ltd.), and narabine, an anti-tumor drug of Zhengda Tianqing, is first declared for listing in China (3) In May, Jiangsu Hengrui obtained clinical approval documents for two new class 1.1 chemical drugs, namely, the antineoplastic cimetidine and the diabetes drug furoglitazone Hengrui has been in the leading position in the field of innovative drug research and development in China These two varieties have been approved clinically, which may make the company have a breakthrough in the field of anti-tumor drugs and oral hypoglycemic drugs research and development In addition, bevaludine for injection, a new anticoagulant drug of class 3.1 from Haosen, Jiangsu Province, has been approved for production (the current status of its API is that the on-site inspection has been completed), which is the second enterprise in China to obtain production approval documents for the product After its listing, it will break the monopoly position of the first imitator, xinlitai, in the domestic market Table 2 New chemical drugs of categories 1.1 and 3.1 approved for clinical use and marketing in May 2014 2 In May, CDE accepted 40 chemical drug import applications, slightly less than last month (47) A total of 28 varieties are involved, of which 7 varieties are applied for listing and 21 varieties are applied for clinical application It is worth noting that in the clinical application, Merck's diabetes drug mk-3102 tablets, Weicai's weight-loss drug chloranthine hydrochloride tablets, Roche's anti-tumor drug alectinib capsule, AB science's anti-tumor drug masetinib mesylate tablets are all the first clinical applications for imported new drugs in China 3 Acceptance of generic drugs in May, CDE accepted 179 chemical generic drugs applications, involving 101 varieties and 113 enterprises (not combined with subsidiaries under the same group), almost the same as that in April As shown in Figure 5, these generic drugs are mainly concentrated in the fields of systemic anti infective drugs, gastrointestinal and metabolic drugs, nervous system, cardiovascular system, anti-tumor drugs and immunomodulators （2） Acceptance and evaluation of biological products in May, CDE accepted 18 applications for new biological products with acceptance number, of which only one new type of class 1 drug was applied for clinical application of influenza a h7n9 split vaccine by Shanghai Institute of biological products H7n9 influenza virus split vaccine was initially declared clinical by Hualan biological vaccine Co., Ltd in January this year After that, Beijing Tiantan biology and Beijing Kexing biology successively declared that Shanghai Institute of biological products is the fourth h7n9 vaccine manufacturer accepted by CDE In May, there were 9 applications for import of biological products, involving 6 varieties Among them, 4 varieties are clinical applications and 2 varieties are listing applications, as shown in Table 3: Table 3 Among the biological products applied for import in May 2014, omazumab of Novartis is the first listing application in China Omazumab is an anti IgE monoclonal antibody, which is used to treat moderate to severe persistent allergic asthma It was first listed in the United States in 2003, and then in many countries Recently, it was approved by the United States and the European Union for a new indication of chronic spontaneous urticaria Novartis applied for clinical application in China in January 2007, and obtained clinical approval document in April 2008 This is the first time in China to apply for listing If this product is listed, it is expected to bring new treatment hope for domestic asthma patients (da ta source: Insight China Pharma da ta database)