CDE Drug Evaluation Report in June 2015

In June, the first class 1.1 ddp-4 inhibitor in China was listed 3.1 the first group to rush to imitate and pile up hepatitis C Gilead's sofosbuvir / gs-5816 combination was first declared in China Haizheng, Renfu, Yangzi River and other enterprises obtained class 1.1 clinical approval documents Sanofi and Pfizer's new biological products were first declared in China The first half of 2015 has been completed Now let's review the number of drug registration applications undertaken by CDE in the first half of 2015: the following is to analyze the application acceptance, review and approval of chemical drugs, traditional Chinese medicine and biological products 1、 Acceptance of chemical application: in June, CDE undertook 684 new chemical registration applications with acceptance number The specific data of each application type are as follows: 1 New drugs (1) the first class 1.1 new drugs in China to apply for listing of ddp-4 inhibitors of class 1.1 According to the statistics of insight database, in June, CDE undertook 13 applications for class 1.1 new drugs with acceptance number, involving 6 Among them, Jiangsu Hengrui's retagliptin phosphate has applied for listing, and the rest are clinical applications The specific data are as follows: sph3127 is the first new drug of class 1.1 of SHP in the past five years, and it belongs to major special evaluation varieties At present, the variety is in the professional review of ind sequence pharmacy and pharmacology and toxicology, while the non major special varieties before and after sph3127 are still in the queue review Jiangsu Hengrui's repagliptin tablet was put on the market in early June 2015, which is the first DPP-4 inhibitor developed by domestic enterprises in the stage of market application Hengrui continues to lead the domestic drug research and development Fns007 powder injection of Hebei FeNiS Biotechnology Co., Ltd is developed in cooperation with many units such as Shijiazhuang Pharmaceutical Group to treat rheumatoid arthritis The drug has obtained the national "major new drug creation" science and technology major special support, but it does not belong to the major special review varieties At present, the ind queue number is 433 The indication of tq-b3395 declared by Zhengda Tianqing is not available Last year, Zhengda Tianqing group, which focused on 3.1 and 6 generic drugs, launched new drug research and development this year In the first half of this year, it has applied for two 1.1 new drugs Cn128 is a class 1.1 new drug of Hangzhou Zede medicine, and its indications are not known for the time being Hangzhou Zede pharmaceutical is a small and medium-sized technology enterprise established in 2013, which is controlled by Zhejiang hangkai group and Hangzhou saibole Morningstar investment company Jiangxi Qingfeng Pharmaceutical Co., Ltd of Qingfeng Pharmaceutical Group declared sc10914 tablets at the end of June, which may be an anti-tumor drug with the target of PARP inhibitor In the field of anti-tumor, Jiangxi Qingfeng has been focusing on the research and development of new drugs for liver cancer, gastric cancer and lung cancer (2) 3.1 new drugs 3.1 the first group to rush to imitate the cluster hepatitis C field CDE undertook a total of 178 new chemical drugs 3.1 new drug applications with acceptance number in June Among them, there are 173 clinical applications, involving 72 varieties; 5 listing applications, involving 3 varieties According to the potential variety screening system of insight database, we have screened out the varieties that have applied for class 3.1 new drugs for the first time in China, and they may become the first imitations in China in the future The specific data are as follows: naituopidem palonosetron was developed by Japanese sanitary materials and approved by FDA (trade name akynzeo) in 2014 This drug can prevent nausea and vomiting within 24 hours until 120 hours after chemotherapy While keeping up with the popular anti-tumor drugs, Xiansheng pharmaceutical industry also aims at the anti-tumor drugs that can not be separated from chemotherapy, nausea and vomiting Star hepatitis C drug sofosbuvir has been declared in 15 domestic 3.1 categories (calculated according to the group company's de duplication), while the combination drug sofosbuvir / ledipasvir has not been involved by domestic enterprises Until June, Beijing Wansheng Pharmaceutical Co., Ltd declared redipavir API and redipavir tablets, the first in China Fosamprenavir, a former research enterprise of GlaxoSmithKline, is used for the treatment of AIDS The drug was listed in the United States as early as 2003 (trade name lexiva), and its global sales in 2010 exceeded 100 million US dollars Zhejiang Huayi pharmaceutical is the first enterprise in China to declare the drug Daclatasvir is an NS5A inhibitor used by Bristol Myers Squibb to win the market of hepatitis C its trade name is daklinza, which has been listed in Europe and Japan However, it was forced to withdraw its application in the United States This year, it is expected to know the FDA's approval results Jiangsu Wanbang biochemical bypassed the popular sofosbuvi, favoring daclatasvir, and was the first one in China to rush to apply for imitation 2 In June, the highest number of generic applications for generic drugs of digestion and metabolism was reported CDE undertook 188 new applications for generic drugs with acceptance number, involving 105 varieties and 112 enterprises (the same as the group's subsidiaries without merger) The number of generic applications in the mainstream fields of digestion and metabolism, anti infection, cardiovascular and neurology continued to increase, especially in the field of digestive tract 3 For the first time in China, CDE has undertaken 35 new chemical import registration applications with acceptance number, involving 24 varieties Among them, there are 22 clinical applications involving 14 varieties, 13 listing applications involving 10 varieties Among them, the newly developed sofosbuvir / gs-5816 compound drug of the ambitious Gilead company was declared in China for the first time The results of the second phase clinical trial showed that 96% of the patients were cured after 8 weeks of treatment, and now they are in the third phase clinical stage Chemical approval: Haizheng, humanwell, Yangzijiang and other enterprises obtained class 1.1 clinical approval documents According to insight database statistics, Yangzijiang, Zhejiang Haizheng, Yichang humanwell and other enterprises obtained 5 clinical approval documents of chemical 1.1 new drugs in June (subject to the status of "certificate preparation completed - approved documents issued"), of which 4 Varieties belong to special review varieties, but this does not seem to bring the advantage of review and approval time The specific data are as follows: 2 In June, CDE of traditional Chinese medicine undertook 34 new applications of traditional Chinese medicine with acceptance number Among them, there are only 9 new drug applications, 19 supplementary applications, 3 import applications, 2 import re registration applications and 1 copy application 3、 In June, CDE of biological products undertook 49 new applications for biological products with acceptance number The specific data are as follows: among biological products, the first application includes: the asthma drug dupilumab (sar153191) and anti rheumatism drug cooperated by Sanofi and Zaiyuan Sarilumab (sar231893) and tanezumab, a new pain drug cooperated by Pfizer and Lilly Sanofi hopes to stand out in the anti rheumatism market with strong momentum of doxorubicin-6 (IL-6) sarilumab At the same time, Sanofi is also stepping up the research and development of a new asthma drug for injection, dupilumab The clinical trial data of the drug is gratifying Currently, it has entered the third phase of clinical trials in the United States Pfizer and Lilly jointly developed the blocking nerve growth factor (NGF) tanezumab, which will be a new type of drug for chronic pain (including osteoarthritis and cancer-related pain), and will restart the three-phase clinical trials that were limited by rare side effects in 2015.