November 2014 CDE drug review report

Key points: East Sunshine new report in 2014, class 1.1 anti hepatitis C drug, imitavir, has been approved by the Academy of clinical military sciences to declare the proposed anti Ebola drug, fabilavir, and sofosbuvir, another three enterprises in China to declare that the sleeping drug of Nanjing Warwick, rimetidine, has been approved for clinical use, but has not come or is the first to imitate it According to the latest statistics of dingxiangyuan insight database, there were 673 new drug registration applications undertaken by CDE in November, a slight increase compared with last month (608) Overall, the total amount of drug acceptance of CDE in each month of this year remained relatively stable Next, let's take a look at the application acceptance, review and approval of chemical drugs, traditional Chinese medicine and biological products 1、 Chemical application acceptance: in November, CDE undertook 594 new chemical registration applications with acceptance number, a slight increase compared with last month (541) The specific data of each application type are as follows: 1 In November, CDE undertook 206 new chemical and new drug applications There are 194 clinical applications and 12 listing applications (1) 1 In November, only one chemical drug, 1.1 new drug, was applied for clinical application: According to DXY insight database, in November, only one chemical drug, class 1.1, was applied for clinical application, which was less than that in the previous month It was the paclitaxel (PDG coupling type) API and injection declared by China Pharmaceutical Research and Development Center Co., Ltd under China Resources Pharmaceutical Group Paclitaxel is an anti-tumor drug widely used in clinic It can promote the polymerization of microtubules and stabilize the polymerized microtubules, so as to prevent the division and proliferation of cancer cells and achieve the anti-cancer effect Paclitaxel has been on the market for many years and can be used in combination with other anti-tumor drugs, mainly for the treatment of ovarian cancer, breast cancer, etc in recent years, it has been approved for other indications, such as pancreatic cancer, cervical cancer, non-small cell lung cancer, etc Coupling antitumor drugs with polyglutamic acid, polyethylene glycol, albumin and other macromolecular carriers has the advantages of improving drug targeting, reducing toxic side effects, increasing drug water solubility and prolonging drug efficacy It is a common modification method of antitumor drugs (2) the Military Academy of new drugs of category 3.1 applied for the anti Ebola drug fabiravir, and sofosbuvir added three enterprises to apply: in November, CDE undertook 171 applications for new chemical drugs of category 3.1, including 159 clinical applications, involving 61 varieties; 12 listing applications, involving 8 varieties Among them, we select the first clinical application varieties and corresponding enterprises in China according to the DXY insight database, and they may become the first ones in China in the future It is worth noting that the Institute of toxicants and drugs of the Academy of Military Sciences has declared the antiviral drug fabiravir The drug was developed by Fushan chemical industry company, a subsidiary of Fujifilm holding company in Japan It is a selective inhibitor of RNA polymerase, which can effectively inhibit virus replication In March this year, it was approved by the Ministry of health and welfare of Japan for the treatment of influenza Fabiravir is currently considered to be one of the most promising drugs against the Ebola virus In addition, jk-05, an anti Ebola drug previously shipped from China to Africa, is either a fabiravir analog or a generic of fabiravir, which is developed by Sihuan pharmaceutical and military academy in cooperation According to the announcement issued by Sihuan pharmaceutical in October, Sihuan pharmaceutical will pay 10 million yuan of project technology transfer and R & D expenses to the Academy of Military Sciences and obtain all the property rights and management rights of the drug The cost will be paid in stages according to the drug development process until the production approval is obtained In addition, among the 3.1 new drug varieties declared in November, sofosbuvir (trade name: sovaldi, Chinese Name: sofibwe, sofobuvir), a star drug of hepatitis C of Geely, has been declared by Sichuan Kelun, Petrochemicals Group and Zhengda Tianqing successively in November, following the declaration of Beijing Kawei Biomedical Technology Co., Ltd in October, and the competition is quite similar violent 2 There are still many enterprises that have just applied for excessive repeat varieties of generic drugs: according to the statistics of dingxiangyuan insight database, in November, CDE undertook 144 new chemical generic drugs applications with acceptance numbers, involving 90 varieties and 86 enterprises Some of them are CFDA and our insight's over duplicated generic drugs, and these enterprises are the first to declare these over duplicated generic drugs in November, not re registration and supplementary application, which is amazing For example, metronidazole declared by Shaanxi bubo, atorvastatin calcium declared by Xinxiang Changle Pharmaceutical Co., Ltd and Hainan Haili pharmaceutical, ambroxol declared by Shanghai Hyundai, Ozagrel declared by Hainan Meida, dexamethasone declared by Jiangsu Yuanda xianle pharmaceutical, etc We can see the problem of excessive repeat declaration of generic drugs 3 In November, CDE undertook 28 new chemical import registration applications with acceptance number, involving 18 varieties Among them, the following varieties are first applied for in China: examination and approval: new chemical drugs of class 1.1: imitavir, a new drug of class 1.1 of Guangdong dongyangguang, was approved for clinical use in November, and imitavir phosphate, a new anti hepatitis C drug of class 1.1 of Guangdong dongyangguang, was approved for clinical use in November The drug is a major special variety According to the review of special approved varieties, it was declared in January this year and obtained clinical approval in November, which is quite rapid In addition, the approved 1.1 new drug varieties include scutellarin, an anti-tumor drug of China Pharmaceutical University (APIs and injections), and xidaban, an anti-tumor drug of Shenzhen micro core Biology (APIs and tablets) According to the latest data of dingxiangyuan insight database, scutellarin from China Pharmaceutical University has been approved for clinical application, and the on-site inspection of Shenzhen micro core bio xidaban has been completed Chemical medicine class 3.1 new drug: rimetidine of Nanjing Warwick has been approved for clinical use, and may be the first to imitate rimetidine in the future It is a sedative and hypnotic drug developed by Takeda pharmaceutical of Japan It was approved by FDA of the United States for listing in July 2005 and used to treat insomnia It was listed in Japan in July 2010 Takeda has applied for clinical application in China in November 2007 and obtained clinical approval in September 2009 Nanjing Huawei applied for clinical application in July 2011, and obtained the clinical approval document in November this year It is the first domestic manufacturer to apply, and the only domestic enterprise to obtain the clinical approval document at present In the future, if it goes smoothly, it should be the first one in China 2、 The application data of Chinese medicine newly undertaken by CDE in November is as shown in the figure: 3 There are 41 new applications for biological products undertaken by CDE in November, including 17 new drugs, 4 imports and 20 supplementary applications There are 5 kinds of new drugs in Category 1, among which the typhoid Vi polysaccharide protein binding vaccine of Lanzhou Institute of biological products is a listing application, and the enterprise varieties are all clinical applications The specific data are as follows: