2014年美国批准新药情况分析  

Analysis on New Drugs Approved by FDA in 2014

作　　者：张华吉[1] 唐菀晨[1] 李旭[1] 

机构地区：[1]国家食品药品监督管理总局信息中心,北京100053

出　　处：《中国药物评价》2015年第2期114-117,共4页Chinese Journal of Drug Evaluation

基　　金：科技部国家人口与健康科学技术共享平台;项目名称:药学科学数据中心建设

摘　　要：目的:研究2014年美国新药批准情况,供我国药品监管及新药研发人员参考。方法:通过查询美国食品和药物管理局(FDA)官网发布的2014年批准新药数据,结合历年美国新药批准情况,对2014年美国新药批准情况进行分析。结果与结论:2014年FDA共批准41种新分子实体药物(new molecular entities,NMEs),批准新药上市申请(new drug applications,NDAs)30种、新生物制剂上市申请(biologics license applications,BLAs)11种。新药批准数量较2013年27种有显著提升,增长50%,与近5年的平均值31.6种相比,高出30%;共受理新药上市申请41种,与往年相比,总体保持相对稳定;新药创新程度较高,17种新药获批首创一类新药;孤儿药热度依然不减,17种孤儿药获得批准;有9种新药通过创新突破性疗法通道获得批准;新药研发重点领域集中在抗肿瘤药、抗感染药、代谢及内分泌系统药物及神经系统药物。2014年美国制药研发企业已更加注重新药开发效率,新药研发依然体现强者恒强的局面。Objective：To provide information for drug regulators and new drug researchers by analysing new drugs approved by the U.S.Food and Drug Administration（ FDA） in 2014.Methods：We retrieve the data issued in FDA official website,and analysis the bas-ic situation of the new drugs approved in U.S.Results＆amp; Conclusion：FDA approved a total of 41 novel new drugs,know as new molecu-lar entities （NMEs） in 2014, including 30 new drug applications （NDAs） and 11 new biological applications （BLAs）.Approvals were up by over 50% from the 27 approved in 2013, and up 30%from the 5-year average of 31.6 per year.The number of NMEs applications in 2014 with 36 applications was overall relatively stable.2014 was the biggest year to date for first-in-class and orphan-drug approvals, with 17（41%） first-in-class and 17 （41%） orphan designees in the approval cohort.9 NMEs had breakthrough-therapy designation.The current focus for drug R＆amp;D is on antineoplastic drugs, antimicrobial drugs, metabolism and endocrinology drugs,neurolagy drugs.Encouraging signs in 2014 showed that, U.S.pharmaceutical industry has paid more attention to how to improve the efficiency of the de-velopment of new drugs.

关 键 词：创新药物 新药研发 新分子实体 新药批准 

分 类 号：R95[医药卫生—药学]