CDE Drug Evaluation Report in July 2016

Hot spot in July, application volume picked up in July, but it was still low, new class 1 drugs declared by new registration classification appeared for the first time in July, advanced biological anti HIV ibovetai declared to be on the market, PD-1 monoclonal antibody pdr001 of Novartis undertaken by CDE, human papillomavirus adsorption vaccine of GSK was approved to be on the market, application volume picked up in July, but it was still low According to the latest statistics of Insight China Pharma data database of DXY, in July 2016, there were 271 new drug registration applications undertaken by CDE with acceptance number, up from last month, but the acceptance volume is still very low Next, we will analyze the application acceptance, review and approval of chemical drugs, traditional Chinese medicine and biological products in July 2016 ◆ application acceptance 1 According to insight database statistics, CDE undertook 220 new chemical registration applications with acceptance number in July 2016, up from last month 1 New drugs (1) class 1 new drugs first appeared in July, class 1 new drugs declared by new registration classification according to insight database statistics In July, CDE undertook 9 class 1 new drug applications for chemical drugs with acceptance number, involving 6 varieties, including 1 variety applied for listing, and others are clinical applications Aibo Weitai, a national first-class new drug independently developed by frontier bio Pharmaceutical (Nanjing) Co., Ltd., was listed in July The drug was first applied for clinical application by its subsidiary Chongqing frontier Biotechnology Co., Ltd in 2007, and all the preset clinical end-point indicators were achieved in phase III clinical trials in advance Zaiding pharmaceutical declared in July that alanine - brinib tablet is an oral kinase inhibitor, which is mainly used to treat HCC and other solid tumors At present, the highest research and development progress in the world is phase III clinical The drug was first developed by Bristol Myers Squibb In March 2015, it authorized zaiding pharmaceutical to have the exclusive right of development, production and commercial promotion of the drug in China, including Hong Kong and Macao Suzophubuweipatavir tablet, which is declared by Jiliya (Hangzhou) Pharmaceutical Co., Ltd., is a protein inhibitor of hepatitis C virus NS 5 and is used for the treatment of hepatitis C The drug was approved for marketing in the European Union on July 8 this year The spray dried dispersible tablet, which is declared with the drug, is the raw material of WEP Fg-4592 capsule, which is declared by fabergin (China) Pharmaceutical Technology Development Co., Ltd., is an oral hypoxia inducible factor proline hydrogenase inhibitor It has the functions of stimulating erythropoiesis, regulating iron metabolism and reducing the level of ferritin At present, clinical research is used to treat anemia, and the highest research and development progress is phase III clinical The drug was first applied for clinical application by Beijing famarezzi Technology Co., Ltd in July 2009 However, there is no information about the application of F [18F] alpha peptide by Jiangsu shimekang Pharmaceutical Co., Ltd (2) In July 2016, CDE undertook 5 applications for new chemical drugs of category 1.1, involving 2 varieties, all of which were clinical applications Gma204 capsule, which was declared by Hangzhou Hongyun Huaning Biomedical Engineering Co., Ltd., is a new generation of tyrosine kinase inhibitor It is applied to NSCLC with EGFR mutation in clinic It provides new hope and choice for advanced patients with chemotherapy failure or resistance to the first generation of EGFR inhibitors and new T790M mutation There is no information about hl-085 capsule and its API declared by Shanghai Kezhou pharmaceutical research and Development Co., Ltd (3) In July 2016, CDE undertook a total of 15 applications for new chemical drugs of category 3.1, involving 6 varieties, all of which were clinical applications 3.1 the acceptance volume of new drugs of category 1 is becoming less and less, at the same time, there are three types of generic drugs applied for acceptance on August 1 2 In July 2016, CDE undertook a total of 55 chemical and generic drug applications with acceptance number, which is not much different from 53 applications last month 3 In July 2016, CDE undertook 5 new chemical import registration applications with acceptance number, down from last month All applications involved 3 varieties, among which imported chemical drugs declared according to new registration classification 5.1 and 5.2 have appeared PS: 5.1 applies for listing of the original research drugs listed overseas in China, and 5.2 applies for listing of the non original research drugs listed overseas in China This month, three imported chemicals were declared in China They are the 5.2 imported chemicals of Novartis, salmeterol and ticasone powder, which are used to treat asthma and chronic obstructive pulmonary disease The drug was first developed by GlaxoSmithKline and approved by FDA on August 24, 2000 Ixazomib capsule, a class 5.1 imported drug declared by Takeda pharmaceutical, is a proteasome inhibitor, which is used to treat patients with multiple myeloma The drug was declared by Takeda pharmaceutical and approved by FDA on November 20, 2015 Plx3397 HCl capsule declared by Kuntai enterprise management (Shanghai) Co., Ltd is a CSF-1R inhibitor, which is used for the treatment of pigmented villonodular synovitis (giant cell tumor of tendon sheath bone) At present, the drug has carried out a number of clinical studies in the world, among which the clinical trials for the treatment of pigmented villonodular synovitis have entered the third stage 2、 In July 2016, CDE undertook 21 new applications of traditional Chinese medicine with acceptance number, including 3 re registration of imports (involving 1 variety), 3 new drug applications (involving 3 varieties) and 15 supplementary applications (involving 14 varieties) It's down from last month 3、 In July 2016, CDE undertook 26 new applications for biological products with acceptance number Among them, 7 new drug applications (involving 6 varieties), 9 import applications (involving 3 varieties) and 10 supplementary applications (involving 8 varieties) In the pdr001 CDE declaration of PD-1 monoclonal antibody of Novartis, another PD-1 monoclonal antibody is pdr001 declared by Novartis At present, the drug has carried out a number of clinical studies all over the world, among which the clinical trials for the treatment of NPC have entered the second phase of clinical trials, and Novartis launched the drug for the treatment of solid tumor I / II clinical trials on July 18 this year At present, China has 9 declared PD-1 / PD-L1 drugs (5 of which are imported) ◆ review and approval 1 According to the advanced screening of insight database, a total of 879 acceptance numbers completed the review in July 2016 (including acceptance numbers entering the approval stage and existing review conclusions) The total number of completed reviews decreased compared with last month, while the number of completed reviews of traditional Chinese medicine and biological products increased 2 In July 2016, 789 chemical acceptance numbers completed the review As shown in Figure 4, the number of completed reviews of each sequence in July is similar to that in the previous month, and the number of completed reviews of Anda and ind is low, while the number of completed reviews of confirmatory clinical and supplementary applications is large 3 In the aspect of clinical approval of class 1.1 new drugs, according to insight database statistics, there are 13 class 1.1 new drugs approved in July, involving 33 acceptance numbers The number of clinical 1.1 new drugs increased from last month 4 Review and approval of class 1 biological products in July, the number of approved clinical products of class 1 biological products was 2 They are the mouse nerve growth factor for injection of shutaishen (Beijing) biopharmaceutical Co., Ltd and the recombinant human papillomavirus type 16 E7 fusion protein vaccine for treatment of Shanghai Zerun Anke biopharmaceutical Co., Ltd Shanghai Zerun Anke biopharmaceutical Co., Ltd is a subsidiary of Yunnan Watson Biotechnology Co., Ltd on August 8, 2013, the company obtained the material with immunity American invention patent authorization certificate, and began to develop the recombinant human papillomavirus type 16 E7 fusion protein vaccine for treatment with the patent According to the insight database drug development history query function, Yunnan Watson Biotechnology Co., Ltd has applied for the clinical application of recombinant human papillomavirus bivalent (16 / 18 type) vaccine (yeast) as early as July 2009 At present, the 16 types of enterprises in application are: Chengdu Institute of Biological Products Co., Ltd., Beijing Kangle Weishi Biotechnology Co., Ltd and Shanghai Bowei Biotechnology Co., Ltd GSK human papillomavirus adsorptive vaccine was approved for marketing In July, GSK's human papillomavirus adsorptive vaccine was approved for import by CFDA After more than ten years, GSK's human papillomavirus adsorptive vaccine was approved for marketing in China, and it is also the first HPV vaccine approved for marketing in China.