Analysis report of CDE drug review in January 2015

Attention: the 1.1 class of new drugs, DTRMHS-07, approved by the state's new drug, Sida, is listed as the 1.1 new drug of Zhejiang Hai Zheng pharmaceutical company The declaration is accepted by 1.1 new drugs, AD16, which are accepted by Guangdong Southern China new drug creation center According to the latest statistics of drug intelligence registration and acceptance database, in January 2015, CDE undertook 509 new drug registration applications with acceptance number (excluding reexamination, the same below) Among them, there are 435 chemical drugs, 20 traditional Chinese medicine and 56 biological products Next, let's analyze the registration acceptance and evaluation of chemical medicine, traditional Chinese medicine and biological products Figure 1 acceptance of CDE drugs in 2014 and January 2015: compared with December 2014, the number of drug acceptances in January 2015 decreased significantly (see the drug review report in December 2014 for details); Compared with the same period in 2014, the number of chemical acceptance decreased by 44.2% (I wonder if it is related to the recent personnel adjustment of CDE? I in January, CDE undertook 435 new chemical registration applications with acceptance number, 154 new drugs, and the number of generic drugs was 54.7% lower than that in January 2014 Figure II Acceptance of CDE in January 2014 and 2015 The following is a detailed analysis of the acceptance of CDE in January 2015 1 In January, the number of new chemical drugs declared was 154, accounting for 35.4% of the total 66.9% of them are new drugs of category 3.1, and 9.7% of them are new drugs of category 1.1 1) there are 14 new drugs of category 1.1 accepted by CDE this month The figure below shows the new class 1.1 drugs in January AD16, a new 1.1 drug for Alzheimer's disease, was reported by the Guangzhou Institute of medicine and health and the Southern China new drug discovery center of China Academy of Sciences It has been officially accepted by the State Food and Drug Administration and declared the clinical research of new drugs The new drug, Guangdong, was approved by the State Food and drug administration As a representative of the major innovative chemicals of South China new drug and Health Institute, AD16 has a new target, a new structure and independent intellectual property rights in the world AD16 can become a new generation of heavy drugs for the treatment of Alzheimer's disease This compound has a revolutionary breakthrough in Alzheimer's disease as a neuroinflammatory inhibitor, and points out a new direction for future anti Alzheimer's drugs The preclinical pharmacodynamic study showed that the mechanism of action of AD16 was different from that of traditional drugs, and the effect of AD16 was equivalent to that of donepezil and memantine, which were currently on the market, and the drug-forming effect of AD16 was better than that of the same kind of foreign developed varieties Through other preclinical studies, including pharmacy, acute toxicity experiment, pharmacokinetics and a series of experimental studies, the project has been evaluated from different aspects It is proved that AD16 has clear target, definite effect, large safety window, good safety, excellent drug-forming performance and good development prospect The successful application of AD16 indicates that the research and development of the drug has made important progress It has a good prospect of drug preparation and development Eiglitazine (bi10773), an oral drug for the treatment of adult type 2 diabetes mellitus, is a class 1.1 new drug dtrmhs-07 declared by Zhejiang Haizheng at the end of 2014 CDE undertook the application on January 19, 2015, and the acceptance number entered the evaluation center Dtrmhs-07 is a nervous system drug, but its target and indications have not been known Since 2006, Haizheng has applied for 8 new drugs of class 1.1 Attachment: new molecular body with global patent protection independently researched and developed by Shenzhen micro core Biotechnology Co., Ltd., the first subtype selective histone deacetylase (HDAC) oral inhibitor in the world, and the national 1.1 new drug sildabenzamine (epsilon) approved on January 1, 2015 , which was approved by the State Food and Drug Administration (CFDA) on December 23, 2014 Cidabamide belongs to a new mechanism of action - epigenetic regulators of anti-tumor drugs CFDA approved it for the treatment of relapsed and refractory peripheral T-cell lymphoma The clinical trial of sidabamide combined with other anti-tumor drugs in the treatment of non-small cell lung cancer and recurrent and metastatic breast cancer is in progress It took 12 years from the discovery to the approval of xidaban, which is a special subject of "863", "11th Five Year Plan" and "12th Five Year Plan" of China 2) 3.1 new drugs in January the center accepted 103 applications for chemical drugs in category 3.1, 43 varieties, involving 42 application enterprises The following table is the exclusive acceptance varieties of new drugs in category 3.1 in January 2 In January, CDE of traditional Chinese medicine undertook 18 new applications for registration of traditional Chinese medicine with the acceptance number Figure 3: CDE's acceptance of traditional Chinese medicine in January 2015 In January, there were 56 applications for registration of biological products undertaken by CDE with acceptance number Figure 4 acceptance of CDE biological products in January 2015 the following is the newly accepted application for new biological products in January The above data are from the registration and acceptance database of pharmaceutical intelligence