Analysis report on CDE drug review in December 2014

According to the latest statistics of drug intelligence registration and acceptance database, in 2014, CDE undertook 8789 new drug registration applications with acceptance number (excluding reexamination, the same below) The figure below shows the trend chart of the number of drug registration applications of CDE in the whole year Figure 1 In December 2014, CDE undertook 720 new drug registration applications with acceptance number (excluding reexamination, the same below) There are 625 chemical drugs, 49 traditional Chinese medicine and 45 biological products Next, let's analyze the registration acceptance and evaluation of chemical medicine, traditional Chinese medicine and biological products Figure 2 Acceptance of CDE drugs in December 2014 1 In December, CDE of chemical drugs undertook 625 new chemical registration applications with acceptance number, focusing on new drugs, generic drugs and supplementary applications Figure 3 The acceptance of CDE in December 2014 is analyzed in detail below 1 New drug Figure 4 Acceptance of new chemical drugs by CDE in December 2014: 177 new drug applications, accounting for 28.3% of the total number of chemical applications 69% of them are new drugs of 3.1 and 8% of them are new drugs of 1.1 Figure 5 Acceptance of new drugs of CDE in December 2014 1) 14 new drugs of class 1.1 accepted by CDE in this month The figure below shows the new class 1.1 drugs in December The clinical approval documents of class 1 new drug of bocitinib hydrochloride applied by Guangdong dongyangguang Pharmaceutical Co., Ltd were accepted In January 2014, the company declared two new class 1 drugs, respectively, lelotinib mesylate and imitavir phosphate, respectively, for the treatment of tumors and influenza Ethane Selene is a kind of national first-class new drug developed by Gansu Qizheng Tibetan Medicine Co., Ltd in cooperation with Peking University It is a kind of innovative chemical synthetic drug targeting antitumor drugs The results of pharmacodynamics, pharmacology and toxicology showed that ethane Selene is an inhibitor of thioredoxin reductase It can inhibit thioredoxin reductase, at the same time, it has the functions of anti-tumor metastasis, inhibition of tumor growth, regression of formed tumor, and synergistic killing of tumor cells when combined with other drugs The product was approved by the State Food and Drug Administration for clinical use in November 2007 At present, phase II clinical application is accepted The application for production of class 1.1 new drug etakalin hydrochloride raw materials and tablets of Jiangsu Enhua saide Pharmaceutical Co., Ltd., a subsidiary of Enhua pharmaceutical Holding Co., Ltd., was accepted It is worth mentioning that this is the second time that Enhua pharmaceutical has applied for the production approval of etakalin hydrochloride In 2001, Enhua Pharmaceutical Co., Ltd cooperated with Chinese Academy of Military Medical Sciences and Beijing sedvikang Research Institute to develop the drug, and completed clinical research in 2008 After the product was declared for production, it was required to conduct additional clinical trials in June 2010 due to defects in the clinical trial scheme Etakalin hydrochloride is a new generation of antihypertensive drug with independent intellectual property rights, which is used to treat pulmonary hypertension Attachment: in December 2014, the center accepted 122 applications for new chemical drugs of category 3.1 in total Involving 63 declaration enterprises, the following table is the exclusive acceptance variety of class 3.1 new drugs in December 2、 In December, CDE undertook 49 new applications for registration of traditional Chinese medicine with the acceptance number, most of which were supplementary applications Figure 6 In December 2014, CDE's acceptance of traditional Chinese medicine is as follows: new applications for new traditional Chinese medicine accepted in December 3 There are 45 applications for new biological product registration undertaken by CDE in December with acceptance number Figure 7.2 the acceptance of CDE biological products in December 2014 is as follows: the newly accepted new biological products and new drug applications in December 2014 The above data are from the drug intelligence registration and acceptance database