CDE drug review and analysis report in September 2015

In September 2015, CDE undertook 636 new drug registration applications with acceptance number (excluding reexamination, the same below) Figure 1 total acceptance of CDE drugs from January to September 2015: in September 2015, the total acceptance increased by 10.6% on a month on month basis, with a total of 61 acceptance numbers increased compared with August Figure 2: CDE drug acceptance from January to September 2015, including 554 chemical drugs, 27 traditional Chinese medicines, 50 biological products and 5 pharmaceutical excipients Compared with last month, the number of Chinese medicine applications decreased slightly, and the number of chemical and biological products applications increased Let's analyze the registration, acceptance and evaluation of chemical drugs, traditional Chinese medicine and biological products 1、 In September, CDE undertook 554 new chemical registration applications with acceptance number, up 10.8% month on month Figure 3 acceptance of CDE chemical drugs in April September 2015 the number of new chemical drugs in September increased by 22.8% The following is a detailed analysis of the acceptance of CDE chemicals in September 2015 1 In September, the number of new chemical drugs declared was 199, accounting for 35.9% of the total 1) There are 17 acceptance numbers of class 1.1 new drugs accepted by CDE in this month, involving 7 varieties The figure below shows the new class 1.1 drugs in September Table 1: as a new drug of anti drug resistant tuberculosis, fubitavir, a new type 1.1 drug newly undertaken in September 2015, was jointly developed by Changzhou Yinsheng Pharmaceutical Co., Ltd., Sichuan University and Shanghai Pharmaceutical mingkant new drug development Co., Ltd., and has been approved by the national "12th Five Year Plan" major new drug creation project The target compound has applied for two Chinese invention patents and two international PCT (patent cooperation agreement) patents It is understood that the three parties have also cooperated to develop another new drug, amphetamine, which is a new drug for drug-resistant tuberculosis Finally, the two new drugs will be used in combination in clinical practice to reduce toxic and side effects and shorten the treatment cycle through the effect of different targets It can improve the curative effect of drugs Besinolta, declared by Shanghai Institute of pharmaceutical research, Chinese Academy of Sciences, entered the drug examination center on September 14, 2015 It is understood that the drug is an HDAC inhibitor of double thiazole ring, and the indication should be tumor It was researched and developed by nanfajun research group, with the code name and former name of cf367 and bithiastah Bpi-3016 declared by Beida pharmaceutical is a long-acting GLP-1 analog for the treatment of type II diabetes Table two in September 2015, 1.1 kinds of new drugs approved by the 1.1 category of new drugs, the bromine amine declared by Tianjin Xin Chen Tai Fei medicine, is a new class of chemicals with high penetrating power and used in the treatment of osteoarthritis The spray type may be used to relieve muscle tissue pain and osteoarthritis, and has been approved clinically before Furetinib succinate was applied by Chongqing fuchuang Pharmaceutical Research Co., Ltd for the drug varieties to be recommended for priority review for major new drug creation science and technology special projects It was undertaken by CDE on March 6, 2015, and was successfully approved in less than 7 months It is understood that shr6390 of Hengrui medicine is a CDK4 / 6 inhibitor, and the details are unknown for the time being 2) 3.1 new drug Figure 4 acceptance quantity of chemical drugs from January to September 2015 3) generic drug Figure 5 acceptance quantity of generic drugs 2 CDE acceptance number of new Chinese medicine registration applications in September, including 4 new drugs and 22 supplementary applications Figure 6: acceptance of CDE traditional Chinese medicine from April to September 2015 3 There are 50 new registration application acceptance numbers of biological products undertaken by CDE in September 2015 Figure 7 acceptance of CDE biological products from April to September 2015 application for new biological products increased this month, including 2 class 1 biological products projects Table 3 notes to category 1 biological products newly undertaken in September 2015: queue No up to October 8, 2015 4、 In September 2015, FDA approved 5 new molecular entities and therapeutic biological products Table IV new molecular entities and therapeutic biological products newly approved by FDA in September 2015