CDE drug review report in March 2015

Guide reading: the application volume of new drugs has decreased compared with the previous two months Guangdong Dongyang tiantini, yinglitini hausen, has obtained the following clinical approval documents to analyze the application acceptance, review and approval of chemical drugs, traditional Chinese medicine and biological products 1、 Chemical application acceptance: in March, CDE undertook 616 new chemical registration applications with acceptance number The detailed application acceptance and comparison with the previous two months are shown in the following figure: as can be seen from the above figure, compared with the previous two months, 3 In January, the proportion of new drugs decreased, and the proportion of generic drugs rebounded It has tended to the normal level in the past: the number of applications for new drugs, generic drugs and supplementary drugs was roughly the same, accounting for about 30% each 1 Compared with the previous two months, the application volume of new drugs decreased back to March, and CDE undertook 180 new chemical drug applications with acceptance number, which decreased compared with the previous two months Now, let's take a look at the application and acceptance of new chemical drugs in categories 1.1 and 3.1 (1) class 1.1 new anti-tumor drugs are still popular According to the statistics of Insight China Pharma data database of DXY, there are 18 applications for class 1.1 new drugs jointly undertaken by CDE in March, involving 7 varieties The number is the same as the previous period, and all of them are clinical applications for new drugs The data are as follows: entenole, a histone deacetylase (HDAC) inhibitor, is used in the treatment of breast cancer and lung cancer The drug was developed by syndax company in the United States and was recognized by FDA as a breakthrough therapy in 2013 Yiteng pharmaceutical obtained its exclusive authorization in China and several other Asian countries and regions, and declared for the first time in China in March In addition, syndax has also established a cooperation with MSD to jointly develop breakthrough cancer drug combination therapy Entenole will be combined with pembrolizumab (trade name: keytruda), a new PD-1 drug launched in 2014 by MSD, to treat non-small cell lung cancer and melanoma Iritinib is the fourth tinib drug after ningetinib, lelotinib and boxitinib declared by Guangdong East Sunshine in recent three years Brozopine sodium declared by Zhengzhou University is a new compound developed on the basis of butylphthalide, which is intended to be used for the treatment of mild and moderate acute ischemic cerebral infarction It has been transferred to Zhejiang AoXiang Pharmaceutical Co., Ltd at a price of 45 million yuan in 2014 Tianjin Pharmaceutical Research Institute Co., Ltd is the fourth SGLT2 (sodium glucose cotransporter 2) inhibitor after hengglijing of Jiangsu Hengrui, jiaglijing of Shandong xuanzhu and aigglijing of Shanghai Ellis, which is used to treat type 2 diabetes (2) In September, CDE of Haosen, a new drug of class 3.1, applied for ningtidani of Bolinger, and Haizheng, a new drug of class 3.1, applied for 131 new chemical drugs with acceptance number Among them, there are 122 clinical applications, involving 56 varieties; 9 listing applications, involving 6 varieties According to the potential variety screening system of the insight database of DXY, we have screened out the varieties that have been 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: Jiangsu Haosen declared nintedanib, which is the nintedanib (BIBF 1120) of bringer Ingelheim It is a kinase inhibitor, which has been approved and listed in the United States and the European Union in 2014, for the treatment of idiopathic pulmonary fibrosis and advanced adenocarcinoma lung cancer In August 2007, bringer applied for the clinical application of imported new drugs in China, and in April 2008, it was approved for clinical application So far, it has not applied for listing Jiangsu Haosen is the first domestic enterprise to declare Isapirone, an anti-tumor drug of ebomycin, has the same mechanism as Taxol It can combine with tubulin and cause cancer cells to fail to undergo mitosis and apoptosis The original research enterprise is Bristol Myers Squibb In October 2007, the FDA approved the use of isapirone alone or in combination with capecitabine for the treatment of anthracyclines, taxane derivatives and capecitabine for the treatment of ineffective metastatic or locally progressive advanced breast cancer In September 2004, Squibb applied for clinical application of imported new drugs in China In April 2005, Squibb was approved for clinical application for the first time, but it has not been listed yet Zhejiang Haizheng Pharmaceutical Co., Ltd is the first domestic manufacturer to declare 2 The repeat declaration of generic drugs and generic drugs did not change In March, CDE undertook 184 new applications of generic drugs and generic drugs with acceptance number, involving 111 varieties and 112 enterprises (the same as the group's subsidiaries without merger) Among them, there are still some over repeated varieties such as cefuroxime, esomeprazole and atorvastatin In the 2014 annual drug review report released by CDE in March, the repeated declaration of chemicals, especially generic drugs, was highlighted In the spirit of 2015 National Conference on drug registration and management, which has been widely circulated in the industry recently, it is also clearly pointed out that it is necessary to curb repetitive construction, strictly copy and review, strengthen acceptance, and block low-level repetitive varieties before review At present, no relevant laws and regulations have been officially issued As for the future measures and results, let's wait and see 3 First declaration of import: Roche declared the clinical application of anti-tumor drug taseliib, aiketelon declared the listing of megestat According to the statistics of insight database of DXY, in March, CDE undertook 42 new applications for chemical import with acceptance number, involving 37 varieties in total Among them, there are 26 varieties of clinical application and 11 varieties of listing application Among them, the data of the first application for import clinical and listing in China are as follows: Approval: according to the statistics of insight database, 5 new chemical drugs of category 1.1 obtained clinical approval documents, which were concentrated in the hot treatment field There are 2 diabetes drugs and 3 antitumor drugs The specific data are as follows: 2 There are 42 new applications for traditional Chinese medicine undertaken by CDE in March, and the data of each application type is shown in the following figure: 3 There are 49 new applications for biological products undertaken by CDE in March, including 3 varieties of class 1 new drugs, all of which are clinical applications The specific data are as follows: