Insight: CDE drug review report in January 2015

Guide: chemical 1.1 new drug added SGLT2 inhibitor, Zhengda Tianqing subsidiary declared that clozatinib, a major special anticancer new drug with micro core in Shenzhen, has obtained the production approval document, Hengrui applied for biological products, class 1 new drug for injection, shr-1210 according to the insight of Xiangyuan According to the latest statistics of the database, in January 2015, the drug review center (CDE) of the State Food and drug administration undertook 661 new drug registration applications with acceptance numbers, a decrease compared with the same period last year (887) 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 January, CDE undertook 567 new chemical registration applications with acceptance number, involving 256 varieties The detailed data of each application type are as follows: 1 The application amount of new drugs is nearly twice that of generic drugs There is an abnormal situation In the past months, the application amount of new drugs and generic drugs has always been roughly the same, while in January, CDE has undertaken 235 new chemical drug applications with acceptance number, nearly twice that of generic drugs (122), and there is an abnormal situation In recent years, the state has encouraged drug innovation, guided pharmaceutical enterprises to improve their innovation ability, combine innovation and imitation, and avoided low-level and excessive duplication of generic drugs The concept of research and development of domestic pharmaceutical enterprises is also gradually changing (1) 1 In January, there were 7 chemical 1.1 new drug applications, and SGLT2 inhibitors were added According to the insight database of DXY, in January, CDE undertook 22 chemical 1.1 new drug applications, involving 7 varieties Noratrix, an antineoplastic drug of Beijing Kangchen Pharmaceutical Co., Ltd., is an application for listing, and the other varieties are clinical applications for the first time The specific data are as follows: among them, Shanghai Elis Pharmaceutical Technology Co., Ltd is the third SGLT2 (sodium glucose cotransporter 2) inhibitor in China after Jiangsu Hengrui hengglijing and Shandong xuanzhu jiaglijing, which is used to treat type 2 diabetes SGLT2 is another hot target in the field of diabetes treatment after GLP-1 and DPP-4 in recent years SGLT2 inhibitor can reduce the blood glucose level of diabetic patients by blocking the reabsorption of most glucose by kidney and promoting the excretion of glucose from urine Its hypoglycemic effect is independent of insulin and can be applied to any stage of type 2 diabetes In addition, it has moderate weight loss and stable antihypertensive effect Since dapagliflozin, the world's first SGLT2 inhibitor, was approved by the European Union in November 2012, a total of six SGLT2 inhibitors have been listed But at present, there is no SGLT2 inhibitor antidiabetic drug on the market in China The specific R & D situation is as follows: (2) according to the statistics of insight database, in January, CDE undertook 157 applications for new chemical drugs of category 3.1, including 140 clinical applications, involving 51 varieties; listing application 17 12 varieties Among them, the following varieties and their corresponding enterprises may become the first imitations in China: eldecalcitol is another active vitamin D3 derivative used to treat osteoporosis after alfacalcitol Sino foreign pharmaceutical Co., Ltd was approved for listing in Japan in January 2011, applied for clinical application of imported new drugs in China in October of the same year, and approved for clinical application in December 2014 Zhejiang anglikang is the first domestic manufacturer to declare In January, Lianyungang Runzhong, a subsidiary of Zhengda Tianqing, applied for the drug substance of clozatinib Crazotinib is the first oral anaplastic lymphoma kinase (ALK) inhibitor in the world, which is used to treat non-small cell lung cancer (NSCLC) Pfizer was approved by FDA in August 2011, EU in October 2012, and imported in China in January 2013 Ibrutinib was jointly developed by Johnson & Johnson and pharmacyclics It was approved by the US FDA in November 2013 for the treatment of nested cell lymphoid cancer In February 2014, it was approved by the FDA for a new indication for the treatment of chronic lymphocytic leukemia In October 2014, it was approved by the European Union for listing Johnson & Johnson applied for the clinical application of imported new drugs in China in August 2012, and was approved in April 2013 At present, it is still in the clinical trial stage Hangzhou, China, the United States and East China are the first domestic manufacturers to declare the drug 2 The phenomenon of excessive and repeated application of generic drugs is still serious In January, CDE undertook 122 applications for new generic drugs with acceptance number, involving 67 varieties and 81 enterprises (not merging subsidiaries under the same group) Among them, esomeprazole, ambroxol and fasudil, which have been declared by more than 100 manufacturers, are still the repeat varieties The problem of excessive repeat declaration of generic drugs has become a commonplace, but it still needs attention from enterprises 3 There are 41 new applications for chemical import undertaken by CDE in January, when gligliptin metformin tablets imported from bringlingham were declared for listing Among them, there are 32 clinical applications, involving 22 varieties; 9 listing applications, involving 7 varieties Among them, gligligliptin and metformin, the diabetes drug of bolingyingehan, was put on the market in January The drug is a compound preparation of DPP-4 inhibitor and metformin It was jointly developed by bringer Ingelheim and Lilly It was approved by FDA and EU respectively in January and July 2012 In addition, for the compound drug of DPP-4 inhibitor and metformin, at present, it has been approved to import siggliptin / metformin (July 2012) from mosadon and viggliptin / metformin (December 2014) from Novartis Approval: according to the insight database, in January, three new chemical 1.1 drug varieties obtained clinical approval and one new chemical 1.1 drug variety obtained production approval The specific data are as follows: Chidamide (trade name: epsilon) is a new type of histone deacetylase (HDAC) inhibitor, benzamide compound, which is used to treat relapsed and refractory peripheral T cell lymphoma (PTCL) This is also the first drug approved for PTCL in China, and the listing of this product will fill the clinical gap in China In addition, it should be noted that the product is approved for listing based on phase II clinical data, and further research data should be provided by the enterprise later 2、 In January, CDE undertook 33 new applications of traditional Chinese medicine with acceptance number, and the data of each application type is shown in the figure below Among them, there is one new type of Chinese medicine, hydroxysafflor yellow a of Ruiyang Pharmaceutical Co., Ltd 3、 According to the statistics of insight data of DXY, there are 57 new applications for biological products undertaken by CDE in January The data of each application type is shown in the following figure: among them, there are 5 new types of biological products, and the specific data is as follows: