A brief report on the application of new drugs in Fujian Province in 2014

According to the food and Drug Administration of Fujian Province, in 2014, the number of new drug applications in Fujian Province was 27 varieties, and the number of generic drug applications was 25 varieties, accounting for 52% of the total For the first time, the number of new drug applications exceeded that of generic drugs Kangxinshan led the team to develop new drug, Haixi new drug President kangxinshan developed new drug, Haixi new drug, kangxinshan in the laboratory According to the person in charge of the drug registration office of Fujian food and drug administration, in recent years, Fujian food and drug administration has focused on the innovation of regulatory system and mechanism, made full use of the advantages of regulatory functions, actively promoted the healthy and rapid development of Fujian Medical Health and its related industries, and encouraged and introduced such measures as early intervention, risk assessment and "five fast services" Guide the pharmaceutical manufacturers in the province to expand the research and development field, showing a good development trend in drug research and development In particular, the promulgation of good policies such as the notice of the people's Government of Fujian Province on twelve measures to accelerate the development of the pharmaceutical industry and the detailed rules for the implementation of Fujian food and drug administration to promote the development of the pharmaceutical health-related industries has stimulated the research and development momentum of pharmaceutical manufacturers At the same time, the person in charge said that in 2014, the number of new drug applications exceeded generic drugs for the first time, which also means that "the registered R & D direction of enterprises has gradually changed from imitation to creation, the innovation ability of enterprises has been improved, and the R & D benefits are gradually emerging." Especially in recent years, Fujian Province has successively listed some heavy new drugs and generic drugs, including a new class of recombinant hepatitis E vaccine (E.coli) of Xiamen Wantai Canghai Biotechnology Co., Ltd., raw materials and preparations of adefovir ester, lamivudine and entecavir of Fujian guangshengtang Pharmaceutical Co., Ltd., and anti-tumor of Fuzhou haiwangfu pharmaceutical Co., Ltd New drug tegio tablet, raw materials and preparations of olmesartan ester of Fujian Tianquan Pharmaceutical Co., Ltd., 6 kinds of new traditional Chinese medicine drugs Zhuling Jianpi capsule of Fuzhou Meifeng Pharmaceutical Co., Ltd., injection of guipaizite maleate raw materials of Jinshan Pharmaceutical Co., Ltd., raw materials of docetaxel of Fujian Southern Pharmaceutical Co., Ltd., etc "The first-class new drug polyethylene glycol long-term interference A2B of Xiamen Tebao Bioengineering Co., Ltd., which has been applied for research and development for 13 years, has entered the final stage of application for production review, and is expected to be listed at the end of 2015 or the beginning of 2016 After going public, it will produce huge economic benefits " It is reported that at present, there are four first-class biological products in Xiamen Tebao at different stages of clinical trials The driving effect of innovation has also injected new vitality into the development of Fujian biomedical industry In addition, in order to better promote the drug registration and application of drug manufacturers, Fujian food and drug regulatory system recently completed the investigation of drug manufacturers in Fujian Province According to the results of the investigation, there are currently 39 enterprises with drug registration plans, and it is expected that 123 varieties will be registered and declared, and the number of registration and declaration is expected to increase significantly, twice as much as in 2014 Among them, there are 2 national first-class new drugs At present, there are 214 varieties to be approved by the State Food and Drug Administration in Fujian Province.