CDE drug review report in May 2015

Key points in May: the drug registration fee rose sharply at the end of May, but the number of applications did not decrease Guangdong Dongguang applied for 1.1 diabetes drug, Guangdong Dongguang's first pulmonary hypertension imitating drug, lioxigua Johnson and Johnson, and then applied again for Zhejiang Haizheng and Shanghai Pharmaceutical Research Institute after two clinical applications were not approved According to the latest statistics of insight - China Pharma data database of DXY, there were 797 new drug registration applications undertaken by CDE in May 2015 (calculated by acceptance number, the same below), only a small drop compared with April (846) On May 27, 2015, after the issuance of the charging standards and Implementation Rules for registration of drugs and medical devices issued by the State Food and drug administration, although the registration cost increased by 100 times, there were still 62 registration acceptances undertaken by CDE from May 28 to 31, of which new drugs and import applications accounted for one third 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 May, CDE undertook 699 new chemical registration applications with acceptance number, involving 312 varieties The specific data of each application type are as follows: 1 New drugs (1) 4 chemical drugs (1.1 class) 4 chemical drugs (1.1 class) clinical application of new drugs according to insight database statistics In May, CDE undertook a total of 10 chemical drugs (1.1 class) application with acceptance number, involving 4 varieties, and all of them are new drug clinical applications The specific data are as follows: PGR is the second class 1.1 drug declared by Guangdong dongyangguang in 2015, and PGR is an SGLT2 inhibitor for diabetes Guangdong dongyangguang has previously declared a new class 1.1 drug for anti-tumor and hepatitis C drugs, while dongyangguang has not forgotten the fertile soil of diabetes Gzd824, a BCR ABL T315I kinase inhibitor declared by Guangzhou Shunjian biomedical Co., Ltd., is used in chronic myelogenous leukemia (CML) It is noteworthy that the drug can overcome the resistance of imatinib due to the mutation of BCR ABL T315I The indication of fz016 is unknown Founder Pharmaceutical Research Institute applying for the drug belongs to Peking University medical industry group According to insight database, another drug in founder's application is 3.1 analgesic valproic acid half sodium Meanwhile, according to founder's website, there are two new drugs of 1.1 in total on its R & D line Indications for flavonol glycosides are also unknown According to the patent (cn101244057b) held by the Second Military Medical University of the Chinese people's Liberation Army, flavonol glycosides may have lipid-lowering effect (2) In May, CDE of Guangdong dongyangguang, the first heavy-duty pulmonary hypertension drug, undertook 198 new chemical drug applications with acceptance number Among them, there are 187 clinical applications, involving 74 varieties; 11 listing applications, involving 6 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: riociguat, a soluble guanosine cyclase (SGC) agonist developed by Bayer, is a heavyweight drug for the treatment of pulmonary hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) In 2013, it was granted the qualification of orphan drug by FDA and approved to go on the market (trade name: adempas), but it is still in the clinical stage in China and has not yet been declared to go on the market Guangdong dongyangguang has applied for the drug with 3.1 class new drug imitation Although the speed is not fast, it is expected to become the first domestic imitation enterprise in the future Vonolazan fumarate and camptothecin, which are imitated by China, the United States and East China, are discussed in detail in insight's past reports, and will not be discussed here In addition to China and the United States and East China's rapid imitation of vorolazan fumarate, Jiangsu Haosen, Ruiyang pharmaceutical and Tianjin hankang pharmaceutical also successively applied for the 3.1 category of vorolazan in one month, which is highly competitive 2 Imitation of cardiovascular system, digestive tract and metabolism, anti-tumor and anti infection are still the mainstream fields of application for generic drugs in May CDE has undertaken 178 new applications for generic drugs with acceptance number, involving 98 varieties and 104 enterprises (not merged with the group's subsidiaries), which is slightly lower than that in April The number of generic applications for anti-tumor drugs has increased Cardiovascular system, digestive tract and metabolism, anti infection, anti-tumor and nervous system drugs are still the mainstream fields of generic applications, accounting for more than half of them 3 After two clinical applications for import of Johnson & Johnson FGFR inhibitor jnj-42756493 were not approved, it was again declared that in May, CDE undertook a total of 46 new chemical import registration applications with acceptance number, involving 29 varieties Among them, there are 31 clinical applications involving 18 varieties, 15 listing applications involving 11 varieties Among them, there are two varieties that have been applied for clinical application in China for the first time, namely, the patent blue V sodium salt injection of Kaishun Fuda biotechnology, and the Masha ossifying alcohol of Sino foreign pharmaceutical Co., Ltd It is noteworthy that jnj-42756493, a FGFR inhibitor developed by Johnson & Johnson, has been applied for clinical application for the third time in China, while the first two times have not been approved, and it is currently in the second phase of clinical application in the United States The anticancer drug was developed by astox pharmaceutical, a subsidiary of Otsuka, which is committed to new small molecule therapy, and Johnson & Johnson pharmaceutical obtained its global license Approval of chemical drugs: according to the statistics of insight database, there are two new chemical drugs of class 1.1 obtained by Zhejiang Haizheng and Shanghai Pharmaceutical Research Institute, namely Zhejiang Haizheng and Shanghai Pharmaceutical Research Institute of Chinese Academy of Sciences The specific data are as follows: 2 In May, CDE of traditional Chinese medicine undertook 32 new applications of traditional Chinese medicine with acceptance number, with a slight decrease in number Among them, there are only 2 new drug applications, 27 supplementary applications, 1 reexamination and 2 re registration for import 3、 In May, there were 46 new applications for biological products undertaken by CDE with acceptance number The specific data are as follows: among them, only Beijing kangleyweishi biotechnology company applied for the clinical application of class 1 biological products - recombinant trivalent human papillomavirus (type 16 / 18 / 58) vaccine (E.coli) Although the application for listing of imported HPV vaccine has not made progress, it has not hindered the enthusiasm of domestic enterprises to develop HPV vaccine