CDE drug review report in April 2015

Key points in April, the drug declaration volume reached the highest level since this year, Zhengda Tianqing declared for the first time in nearly four years that the chemical medicine 1.1 new drug Qilu pharmaceutical rushed to copy, quickly took orally once a week, the hypoglycemic drug tragliptin was rushed by domestic pharmaceutical companies to copy, GSK submitted the application for the import and listing of dotilavir Jiangsu Hengrui's new analgesic drug M6G has been approved for clinical use The application, acceptance, review and approval of chemical drugs, traditional Chinese medicine and biological products are analyzed respectively 1、 Acceptance of chemical application: in April, CDE undertook 728 new chemical registration applications with acceptance number, involving 327 varieties The specific data of each application type are as follows: 1 New drugs (1) 8 chemical drugs (1.1 class) 8 chemical drugs (1.1 class) clinical application of new drugs according to insight database statistics In April, CDE undertook a total of 23 chemical drugs (1.1 class) application with acceptance number, involving 8 varieties, and all of them are new drug clinical applications The specific data are as follows: the specific indications of tq-b3234 declared by Zhengda Tianqing are not available for the time being This is Zhengda Tianqing's only chemical 1.1 new drug declared in recent 4 years after its application for sulbutinib in 2011 Zhengda Tianqing is a leading pharmaceutical enterprise in the field of generic drugs in China, but its R & D in the field of innovative drugs still needs to be strengthened At present, it has not been approved to be listed as a class 1.1 new drug Tnp-2092 declared by Danuo medicine is used for gastrointestinal infection In addition to tnp-2092, there are still undeclared new drug candidates tnp-2198 and tnp-2500 with different sterilization mechanisms on the R & D pipeline Naparo is the second class 1.1 new drug declared by Shandong Henri after amoquini According to the research and development progress of the existing product line of Shandong Henry, it is speculated that the drug is kbp-7026, a selective chemokine receptor (CRTH2) inhibitor, which is used to treat inflammatory and autoimmune diseases, such as asthma and chronic obstructive pulmonary disease Ro6889678 declared by Roche is midazolam, hypnotic and sedative Hs-10241 declared by Jiangsu Haosen is a c-met inhibitor and a new anti-tumor drug Betatinib, an EGFR inhibitor, is used in the treatment of non-small cell lung cancer The drug is purchased from Aspedia company with exclusive patent rights in the domestic and Hong Kong and Macao regions, which is invested by the essence pharmaceutical company for 10 million yuan and the future sales commission AstraZeneca declared azd3759 for the treatment of non-small cell lung cancer Asc16 declared by Geli biotechnology is NS5A inhibitor and hepatitis C treatment drug (2) 3.1 Qilu pharmaceutical is quick to catch up with others In April, CDE undertook 210 applications for new drugs of chemical category 3.1 Among them, there are 195 clinical applications, involving 65 varieties; 15 listing applications, involving 12 varieties According to the potential variety screening system of insight database, we have screened out the varieties declared for the first time in China, and they may become the first imitations in China in the future The specific data are as follows: vismodegib, developed by Genentech, Roche's subsidiary, was approved by the US FDA in January 2012 for the treatment of basal cell carcinoma, the most common skin cancer in adults It is also the first FDA approved drug to treat metastatic basal cell carcinoma Belotecan, a camptothecin anticancer drug, was developed by jungentang pharmaceutical company of South Korea It was first listed in South Korea in 2004 and used to treat small cell lung cancer and ovarian cancer Carfilzomib, developed by anyx company, a subsidiary of Amgen, was approved by FDA in July 2012, and was used for the treatment of multiple myeloma patients whose disease worsened after receiving at least two other drugs Sinopharm group is the first domestic manufacturer to declare, but Amgen has declared to import before that Pabociclib is a selective CDK4 / 6 inhibitor It was just approved by FDA in February this year, and its trade name is ibrance, which is used to treat postmenopausal women with advanced / metastatic breast cancer This is also the first FDA approved CDK4 / 6 inhibitor Pfizer applied for clinical application of imported new drugs in China in May 2013, and was approved in July 2014, which is currently in the clinical trial stage Qilu pharmaceutical is the first domestic manufacturer to declare Triagliptin, a super long-acting DPP-4 inhibitor, was just approved for marketing in Japan in March this year, under the trade name of zafatek It is the world's first once a week oral antidiabetic drug, which will undoubtedly provide diabetes patients with more convenient treatment options Qilu pharmaceutical is the first manufacturer in China to apply for the drug, which is quick to copy Up to now, Chongqing Medical Engineering Institute and dongyangguang have also submitted the application for registration of the drug after Qilu, and the competition is quite fierce 2 The application for generic drugs was relatively stable In April, CDE undertook 201 new applications for generic drugs with acceptance number, involving 111 varieties and 116 enterprises (the same as the group's subsidiaries without merger) The number was almost the same as that in March These varieties are mainly concentrated in the treatment of gastrointestinal and metabolic drugs, nervous system, anti infective drugs, cardiovascular system and other fields 3 In April, CDE undertook 34 new chemical import registration applications with acceptance number, involving 28 varieties Among them, there are 17 varieties of clinical application and 11 varieties of listing application Among them, dolutegravir of GlaxoSmithKline is the first domestic listing application Dotilavir, developed by iviv, a subsidiary of GlaxoSmithKline, was approved for listing in the United States and Europe in August 2013 and January 2014, respectively, under the trade name of tivicay It is the second HIV integrase inhibitor on the market in the world after latiravir in methadone In addition, the three in one HIV drug of dautiravilamivudine and abakavir was approved for marketing in the United States and the European Union in August and September 2014, respectively, under the trade name of trimeq Approval: according to the statistics of insight database, in April, 6 new chemical drugs of category 1.1 obtained the clinical approval, and Jiangsu Hengrui, Jiangsu Haosen, Jiangsu Enhua and other enterprises all obtained the clinical approval The specific data are as follows: 2 In April, CDE of traditional Chinese medicine undertook 39 new applications of traditional Chinese medicine with acceptance number, which was almost the same as the previous period Among them, 11 new drug applications, 27 supplementary applications and 1 reexamination 3、 In April, there were 69 new applications for biological products undertaken by CDE with the acceptance number The specific data are as follows: there are 2 varieties of class 1 new drugs, all of which are clinical applications They are the h7n9 influenza virus split vaccine of Beijing Tiantan Biological Co., Ltd and the recombinant human vascular endothelial growth factor receptor antibody human complement receptor 1 fusion protein injection of Xinda Biological Pharmaceutical Co., Ltd.