CDE Drug Evaluation Report in October 2014

Abstract: jiagelijing from xuanzhu, Shandong Province, and sofosbuvir, a new therapeutic drug for hepatitis C from Gilead, a new class 1.1 new drug, were first reported by domestic manufacturers Apatinib, a major special product of Jiangsu Hengrui, was approved to produce the HPV vaccine of mosadong and GSK, and entered the approval stage Next, let's take a look at the application, acceptance, review and approval of chemical drugs, traditional Chinese medicine and biological products 1、 Acceptance of chemical application: compared with the same period of previous years, the acceptance volume increased significantly: in October, CDE undertook 541 new chemical registration applications with acceptance number Due to the National Day holiday, the acceptance volume decreased nearly 18% compared with last month (659) However, compared with the same period of previous years, the acceptance volume is still growing, and the growth part is concentrated on new drugs and generic drugs According to the statistics of dingxiangyuan insight - China Pharma data database, the chemical acceptance of CDE in October in recent three years is shown as follows: 1 In October, CDE undertook 175 new chemical and new drug applications with acceptance number Among them, there are 5 new drugs in category 1.1, involving 2 varieties; 129 new drugs in category 3.1, involving 55 varieties (1) 1.1 new drugs jiaglijing of Shandong xuanzhu and CM118 of Shanghai Zaixin applied for clinical application: according to the data base of dingxiangyuan insight - China Pharma, in October, two new drugs of chemical 1.1 entered CDE, respectively, the antidiabetic drugs jiaglijing of Shandong xuanzhu and CM118 of Shanghai Zaixin applied for clinical application The detailed data are as follows: jiaglijing is another class 1.1 new drug for the treatment of type 2 diabetes declared by Shandong xuanzhu, a subsidiary of Sihuan pharmaceutical, after the DPP-4 inhibitor eglitaine See wo 2013000275 A1 for related patents The drug is a sodium glucose cotransporter 2 (SGLT2) inhibitor It can effectively reduce the blood glucose level of diabetic patients by blocking the reabsorption of most glucose by the kidney and promoting the excretion of glucose from the urine Because of its significant hypoglycemic effect and relatively high safety, as well as the additional effects of weight reduction and blood pressure reduction, SGLT2 inhibitor has become a research hotspot in the field of diabetes treatment in recent years Since dapagliflozin, the world's first SGLT2 inhibitor, was approved by the European Union in November 2012, several SGLT2 inhibitors have been listed in succession The FDA has approved three SGLT2 inhibitors from last year to now, namely, carglitazine (Johnson & Johnson), dalglitazine (AstraZeneca / Squibb) and eparinone (bringer / Lilly) In addition, the same drugs approved for marketing in Japan are: tofogliflozin, ipragliflozin and luseogliflozin However, up to now, none of these drugs have been listed in China, and their current declaration in China is as follows: In China, as early as before Shandong xuanzhu applied for gagrinone, Jiangsu Hengrui applied for clinical application in April 2012, which was the first SGLT2 inhibitor independently developed in China, and obtained clinical approval in April 2013 Now it is in the stage of clinical trial CM118 declared by Shanghai Zaixin pharmaceutical science and Technology Co., Ltd is a c-met inhibitor and a new antineoplastic drug targeted by TiNi It is designed on the basis of the already listed ALK kinase inhibitor of Pfizer, clozatinib It is mainly to overcome the shortcomings of drug interaction of clozatinib, expand the possibility of combination of the drug and other anticancer drugs, so as to improve the therapeutic effect The research and development team led by Dr Liang Congxin, a new drug research and development scientist, is responsible for the research and development of the project In addition, kananji Pharmaceutical Technology (Shanghai) Co., Ltd and xccovery are the same R & D team CM082, which was declared by kananji company in May 2011, is also a targeted anticancer drug It is a VEGFR / PDGFR kinase inhibitor It is an improved design based on the already listed targeted anticancer drug sunitinib of Pfizer, which retains its efficacy but reduces its toxic and side effects See cn101553482 B for the patent It has obtained the clinical approval document in April 2012 and is currently in the clinical trial stage 3.1 sofosbuvir, a natural price hepatitis C drug of Gilead, is the first drug to be declared by domestic manufacturers According to the latest statistics of dingxiangyuan Insight China Pharma data database, in October, CDE undertook 129 new chemical drug applications with acceptance number, of which 122 were clinical applications, involving 51 varieties; 7 were listing applications, involving 6 varieties Varieties It is worth noting that Beijing Kawi Biomedical Technology Co., Ltd has submitted the clinical application of sofosbuvir (APIs and tablets), which is the first application of sofosbuvir from domestic manufacturers, and may become the first one in China in the future As for sofosbuvir (trade name: sovaldi, Chinese Name: soffebuvir, soffebuvir), Gilead's star drug of hepatitis C, I believe you are no stranger Sofosbuvir is a nucleoside NS5B polymerase inhibitor, which was first approved by FDA in December 2013 It is the first drug that can be used in the whole oral treatment of hepatitis C in the world The drug just won the best drug award of the Prix Galien USA award in 2014, in recognition of its major breakthrough in hepatitis C treatment 2 In October, CDE undertook 154 applications for chemical and generic drugs, involving 88 varieties and 90 enterprises (not merging subsidiaries under the same group) These generic drugs mainly focus on cardiovascular system, digestive system and metabolism, anti infective drugs, nervous system, anti-tumor and other treatment fields 3 According to the statistics of dingxiangyuan insight - China Pharma data database, in October, CDE undertook 48 new chemical import applications with acceptance number Among them, there are 37 clinical applications, involving 21 varieties, 11 listing applications and 8 varieties For the first time in China, the imported clinical and listed varieties are as follows: review and approval: apatinib, a major special variety of Jiangsu Hengrui, has been approved for production; according to the statistics of dingxiangyuan insight - China Pharma data database, in October, 360 chemical registration applications with approval number have been approved We mainly selected the first approved clinical and listed varieties in China The specific data are as follows: apatinib of Jiangsu Hengrui is an inhibitor of vascular endothelial growth factor receptor-2 (VEGFR-2), which is used for the treatment of advanced gastric cancer with second-line chemotherapy failure, and is also a national major special variety Hengrui applied for clinical application in April 2006, obtained clinical approval in April 2007, went public in August 2011, and was approved for production in October this year 2、 The data of new applications of traditional Chinese medicine undertaken by CDE in October are as follows: 3 Application acceptance of biological products: in October, CDE undertook 23 new applications of biological products with acceptance number, and the data of each application type are as follows: among them, only 1 new drug in Category 1 This product is a polyethylene glycol recombinant Candida urate oxidase for injection, which is declared by Shenyang Sansheng Pharmaceutical Co., Ltd Review and approval: the HPV vaccine of MSD and GSK entered the approval stage: according to the statistics of dingxiangyuan insight - China Pharma data database, in October, 15 biological products entering the CFDA approval stage at the end of CDE review stage were counted as acceptance numbers Among them, the data of new drugs and import applications are as follows: among them, the human papillomavirus vaccine (HPV vaccine) of mosadon and GlaxoSmithKline, also known as cervical cancer vaccine, has been mentioned in our report in July, and Ding Xiangyuan has also written about the interpretation of HPV vaccine, which will not be described here The road of their registration in China is quite bumpy It has been more than eight years since they started to apply During this period, it has experienced many times of issuance and supplement, and all of them have appeared in CDE's notice of disapproval report As for the result of this approval, we can only wait and see.