CDE drug review report in December 2014

Guide reading: Jiangsu Hengrui and dongyangguang have added 1.1 new varieties; antakalin, a new antihypertensive drug of Enhua pharmaceutical, has been applied for listing again; heplatide, a new Antihepatitis drug of Shanghai Hepu biology, has been approved for clinical use; hebofeiming, a new drug of Haizheng, Zhejiang Province, has been approved for clinical use; Haosen agomelatonin has been listed for the first time in December, and CDE has jointly undertaken new drug registration applications with the acceptance number of 728 , an increase from last month (673), but also a normal fluctuation 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: in December, CDE undertook 630 new chemical registration applications with acceptance number In general, the chemical acceptance volume in each month of this year is relatively stable with little fluctuation The detailed data of each application type of chemical drugs in December are as follows: 1 In December, CDE undertook 177 new chemical drug applications with acceptance number Among them, there are 14 new drugs of category 1, involving 6 varieties; there are 122 new drugs of Category 3, involving 57 varieties (1) In December, there are 6 chemical drugs and 1.1 new drug varieties to be declared: according to the latest display of insight database of DXY, in December, CDE undertook 14 chemical drugs and 1.1 new drug applications with acceptance number, involving 6 varieties Among them, Jiangsu Enhua's etakalin hydrochloride (API and its tablets) is a listing application, and the rest are clinical applications Etakalin, which is declared by Jiangsu Enhua saide Pharmaceutical Co., Ltd., a subsidiary of Enhua Pharmaceutical Co., Ltd., is an ATP sensitive potassium channel opener (KCO) and a drug for hypertension It was once a major national special variety The drug was developed by Enhua Pharmaceutical Co., Ltd in cooperation with the Academy of Military Medical Sciences and Beijing sedvikang Medical Research Institute In January 2003, we applied for clinical application and obtained the clinical approval document in November of the same year In the next few years, the company went through retrial and issuance of supplement, and again applied for listing in December 2014, which has been nearly 12 years In addition, in addition to its use in the treatment of hypertension, Enhua has also applied for a patent of etakalin for the prevention and treatment of renal ischemia-reperfusion injury The related patents can be found in CN 1365967 A and CN 101502502502 a The anti-tumor drug ethane Selene, developed jointly by Qizheng Tibetan medicine and Peking University, is a new organic selenium small molecule drug synthesized with ebselene as the lead compound, which is an inhibitor of thioredoxin reductase (TrxR1) Qizheng Tibetan medicine applied for clinical application in August 2006, and obtained the clinical approval document in November 2007 This application is phase II clinical application Bocitinib, the third chemical 1.1 new drug variety declared by Dong Yangguang in 2014 after imitavir and lelotinib Al8326, which is declared by edcheng medicine, is a multi-target tyrosine kinase inhibitor and is intended to be used in the treatment of acute leukemia, ovarian cancer and other diseases Edcheng is a Sino US joint venture innovative drug R & D company, which is dedicated to the research and development of small chemical anti-cancer drugs, especially tyrosine kinase inhibitors The company has cooperative relations with Jiangsu Hengrui, Xiansheng pharmaceutical, Zhengda Tianqing and other companies The well-known drug apatinib approved by Hengrui in October 2014 is yn968d1 from edcheng Hcp002 declared by Shaanxi synthetic pharmaceutical industry and shr7390 declared by Jiangsu Hengrui are not available for the moment Shr7390 is the fourth new chemical drug type 1.1 declared by Hengrui in 2014 (2) In December, three new chemical drugs of category 3.1 were applied for clinical application for the first time: in December, CDE undertook 122 new chemical drugs of category 3.1 with acceptance number, including 107 clinical applications involving 48 varieties; 15 listing applications involving 12 varieties Among them, according to the insight database of DXY, we select the varieties and corresponding enterprises that have applied for clinical application for the first time in China, and they may become the first ones in China in the future 2 In December, CDE undertook 186 applications for new chemical and generic drugs with acceptance number, involving 102 varieties and 113 enterprises (not merging subsidiaries of the same group) These generic drugs mainly focus on the treatment of gastrointestinal and metabolic drugs, systemic anti infective drugs, nervous system, cardiovascular system and other fields 3 In December, CDE undertook 52 new chemical import registration applications with acceptance number There are 42 clinical applications involving 24 varieties, and 10 listing applications involving 9 varieties Among them, the following varieties are the first application in China: examination and approval: clinical approval: according to the insight database, there are 5 new chemical drugs of category 1.1 approved and approved in December Among them, wx001 of Hangzhou Weixing Pharmaceutical Co., Ltd is not approved, and 4 new drug varieties of 1.1 class have been approved for clinical use The specific data are as follows: approved for listing: Haosen's first imitation of agomelatin was approved for listing in December, a total of 4 new chemical drugs of 3.1 class were approved for listing Among them, Jiangsu Haosen's antidepressant agomelatonin is the first one in China Moxifloxacin is the second API manufacturer in China after Nanjing Unocal Moxifloxacin hydrochloride injection was approved by Chengdu Tiantaishan Pharmaceutical Co., Ltd in December according to five new drugs 2、 In December, CDE of traditional Chinese medicine undertook 51 new applications of traditional Chinese medicine with the acceptance number The data of each application type is as follows: among them, there is one new type of traditional Chinese medicine, which is astragaloside A and astragaloside a glucose injection declared by Guizhou Jingfeng injection Co., Ltd at present, this type has been reviewed according to the special approved varieties 3、 According to the statistics of insight data of Xiangyuan, there were 46 new applications for biological products undertaken by CDE in December, almost the same as last month (41) Among them, there is one new drug of class 1, which is polyethylene glycol recombinant human erythropoietin injection (acceptance No.: cxsl1400113) declared by Shenzhen Saibao bio Pharmaceutical Co., Ltd In addition, the data of biological products declared for import are as follows: