CDE drug review report in February 2015

Key points: • clinical application of 7 chemical 1.1 new drug varieties • clinical application of 6 chemical 1.1 new drug varieties • application of 3.1 new varieties by Jiangsu Haosen, Zhengda Tianqing, Shiyao group, etc • clinical application of recombinant Ebola virus vaccine by the Academy of Military Sciences lasted only one week from acceptance to approval, according to the latest statistics of insight database of Xiangyuan, 2015.2 In January, the drug evaluation center (CDE) of the State Food and drug administration undertook a total of 759 new drug registration applications with acceptance numbers, an increase compared with January (661) Although there are seven days of Spring Festival holiday in February, the number of new CDE acceptance numbers is the highest in five consecutive months On the whole, they all float in the normal range Below, respectively, to analyze the application, acceptance, review and approval of chemical medicine, traditional Chinese medicine and biological products 1、 Acceptance of chemical application: in February, CDE undertook 685 new chemical registration applications with acceptance number, involving 296 varieties The data of each application type is as follows: 1 The proportion of new drug application increased in February In February, CDE undertook 314 new chemical drug registration applications with acceptance number, and the new drug application amount accounted for 46% of the total chemical drug application amount, which was a new record In the past, the proportion is usually about 30% - 40% It seems that enterprises pay more and more attention to the research and development of new drugs, especially the class 3.1 new drugs which have not been listed in China and abroad (1) 1 In February, there were 7 chemical 1.1 new drug varieties applied for clinical application, and the majority of anti-tumor drugs were based on the insight database of DXY In February, there were 7 chemical 1.1 new drug varieties applied for clinical application, which was the same as that in January The specific data are as follows: from the above data, it can be seen that anti-tumor drugs are still favored by enterprises, including TiNi, which has developed overheating Bgb-3111 declared by Baiji Shenzhou is an oral small molecule inhibitor of BTK Btk is an important signal molecule in the B cell receptor (BCR) pathway, which is closely related to a variety of B cell types of malignant tumors, and is also a hot target for the treatment of blood malignant tumors and autoimmune disorders Al2846 declared by Nanjing adcheng is a c-met (C-methionine tyrosine kinase receptor) inhibitor, which has been proved to have significant activity in gastric cancer, breast cancer, colon cancer, renal cell cancer, etc Edcheng is a Sino US joint venture innovative drug R & D company, which is dedicated to the research and development of small chemical anti-cancer drugs, especially tyrosine kinase inhibitors (2) 3.1 new drugs Jiangsu Haosen, Zhengda Tianqing, Shiyao group and other companies introduced new varieties according to the statistics of insight database In February, CDE undertook 223 new chemical drug applications with acceptance number, including 213 clinical applications, involving 77 varieties; 10 listing applications, involving 9 varieties Among them, the following varieties and their corresponding enterprises are first declared by domestic manufacturers, and may become the first imitations in China in the future: among them, the antitumor drugs of Shiyao group, belinstein, adarilis, Jiangsu Haosen, and travanxing, Zhengda Tianqing are all first declared in China Indatero and Novartis were approved for import in June 2012, and Lianyungang Runzhong, a subsidiary of Zhengda Tianqing, declared its API in February, the first declaration among domestic manufacturers Fexolodine and Pfizer have been declared in 2008 They were approved in April 2009 and are still in clinical trial stage Hefei Xinfeng technology is the first one among domestic manufacturers to declare 2 The application of generic drugs is relatively stable In February, CDE undertook 169 new applications of generic drugs for chemical drugs with acceptance number, involving 85 varieties and 97 enterprises (not merging subsidiaries under the same group), with little fluctuation compared with the previous month. Among them, these varieties are mainly concentrated in the treatment fields of nervous system, anti infective drugs, gastrointestinal and metabolic drugs, cardiovascular system, etc 3 First declaration of import in China: Aslan company declared aslan001 for gastric cancer, and Zhaoke pharmaceutical declared that CFLP had 41 new chemical import registration applications in February, which was the same as that in January Among them, there are 34 clinical applications involving 27 varieties and 7 listing applications involving 7 varieties Among them, the following varieties are the first application in China: Aslan's gastric cancer drug aslan001 tablet, and Zhaoke's Tamiflu injection Approval: in February, 6 new chemical drugs of category 1.1 were approved According to the latest display of insight database, in February, 6 new chemical drugs of category 1.1 were approved New drug research and development leaders such as Shiyao group, Beida pharmaceutical, Guangdong dongyangguang, Jiangsu Hengrui will enter the clinical trials The specific data are as follows: among them, the diabetes drug dbpr108 of Shiyao group is a DPP-4 inhibitor, in fact, DPP-4 inhibitors of domestic enterprises have been in the clinical trial stage For example, the competition intensity in the future market can be seen in Jiangsu Hengrui's regletin, Jiangsu Haosen's begletin, Shandong xuanzhu's egletin, Fosun Pharmaceutical / Xinli's egletin and Shandong green leaf's egletin 2、 In February, CDE of traditional Chinese medicine undertook 28 new applications of traditional Chinese medicine with acceptance number The data of each application type is shown in the figure below: among them, there is one new type of traditional Chinese medicine, which is Bailong liquor declared by Chongqing Bailong cancer treatment drug research institute 3、 According to the statistics of insight data of dingxiangyuan, CDE has undertaken 44 new applications for biological products in February The data of each application type is shown in the following figure: there are 3 new varieties of class 1 biological products and 1 new import application All of them are clinical applications The specific data are as follows: among them, the recombinant Ebola virus vaccine declared by the Institute of bioengineering, Academy of Military Medical Sciences of the people's Liberation Army has been approved for clinical use in the same month It took only 20 days before and after receiving the clinical approval, which was faster than expected The review timeline of DXY insight database can clearly see the detailed process and corresponding time point of acceptance number from application acceptance to final approval From the review timeline of insight database, we can see that the recombinant Ebola virus vaccine (acceptance No.: cxsl15000017) was hosted by CDE on February 6 and approved for clinical use on February 12, only for one week