CDE drug review report in September 2014

Next, let's take a look at the application and acceptance of chemical medicine, traditional Chinese medicine and biological products 1、 In September, CDE undertook 659 new chemical registration applications with acceptance number The specific data of each application type and the comparison with the previous two months are shown in the following figure: 1 In September, CDE undertook 211 new chemical new drug applications with acceptance number, almost the same as 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) in September, there are 5 chemical drugs of new drug category 1.1 applied for: according to the data base of insight - China Pharma of dingxiangyuan, there are 10 chemical drugs of new drug category 1.1 applied for by CDE in September with acceptance number, involving 5 varieties, all of which are new drug clinical applications The specific data are as follows: Nanjing Changao Pharmaceutical Technology Co., Ltd declared that oglitaine is a DPP-4 (dipeptidyl peptidase) inhibitor, which is used to treat type 2 diabetes However, according to the insight - China Pharma data database of DXY, there are more than 30 kinds of similar drugs, and the number of declared manufacturers is far above that Figure 2 Screenshot of insight database: oglitaine (dipeptidyl peptidase inhibitor) of the same kind of drugs, among which, the imported and listed drugs in China are: liglitaine (Boling), sigletin (mosadong), wigletin (Novartis), sagletin (Bristol Myers Squibb), and agletin (Takeda) The intensity of competition in the future can be imagined The zhifeisaban declared by Tianjin Pharmaceutical Research Institute is a direct XA factor inhibitor and anticoagulant The same species are apixaban, eduxaban and rivaroxaban According to Tianjin Pharmaceutical Research Institute, it is intended to prevent the formation of deep vein thrombosis and pulmonary embolism in patients after hip and knee replacement There are other potential indications: prevention of stroke and systemic embolism caused by blood clot in patients with non valvular atrial fibrillation; treatment of deep vein thrombosis (DVT) and pulmonary embolism to prevent recurrence of DVT and pulmonary embolism; prevention of atherosclerotic events after acute coronary syndrome Hsk3486 declared by Sichuan haisike Pharmaceutical Co., Ltd is a new type of GABAA receptor (also known as γ - aminobutyric acid A-type receptor) agonist, a fluoroderivative of propofol, which has sedative hypnotic and anesthetic effects For details, see patent Publication No cn 103896743 a Irinotecan is a semi synthetic water-soluble camptothecin derivative It is widely used in clinical anti-tumor drugs for the treatment of colorectal cancer, breast cancer and so on After its first listing in Japan in 1994, it has been listed in many countries around the world Pfizer has been imported into China for a long time, and there are several domestic manufacturers in production Polyethylene glycol (PEG) is a kind of synthetic polymer material, when it is connected with drug molecules, it can increase the relative molecular weight of drug, has the effect of prolonging the efficacy, reducing the toxicity of drug administration, increasing the water solubility of drug, etc., so PEGylation is regarded as a means to improve the clinical effect of drug It is worth noting that in March this year, Zhejiang Haizheng Pharmaceutical Co., Ltd has declared the API and injection of the same kind of peg-sn38 (sn38 is the active metabolite of irinotecan) Peg-sn38 (ezn-2208) was purchased by Haizheng from enzon company in 2012 The specific information of ketamine is not available, but according to the research project of Guangzhou Shunjian Biomedical Technology Co., Ltd., it is speculated that the 1.1 anti leukemic drug d824 transferred from Guangzhou Institute of biomedicine and health, Chinese Academy of Sciences (hereinafter referred to as Guangzhou Institute of Biology) in 2012 is a new protein kinase inhibitor, which can overcome the resistance of imatinib (2) 3.1 new drugs in September CDE undertook 154 new chemical drug applications with acceptance number, including 128 clinical applications involving 53 varieties and 26 listing applications involving 19 varieties According to the potential variety screening system of insight - China Pharma data in dingxiangyuan, we have screened out the varieties that have been declared for the first time in China The data are as follows: 2 In September, CDE undertook 216 new applications for chemical generic drugs, involving 115 varieties Among them, esomeprazole was declared by 6 enterprises in September, which was the most variety of declared enterprises As for esomeprazole, we have mentioned it many times in the data reports of the past months, so we will not repeat it here All in all, the phenomenon of excessive and repeated declaration of drugs in China is still serious 3 According to the statistics of insight - China Pharma data database of dingxiangyuan, in September, CDE undertook a total of 51 new chemical import applications with acceptance number, involving 41 varieties Among them, there are 28 varieties of clinical application and 13 varieties of listing application For the first time in China, the varieties of imported clinical applications are as follows: 2 The application data of Chinese medicine newly undertaken by CDE in September is as shown in the figure; 3 There are 31 new applications of biological products jointly undertaken by CDE in September, including 3 varieties of class 1 new drugs, all of which are clinical applications The specific data are as follows: