我国小分子靶向抗肿瘤药物申报现状浅析  

Application status of small molecule targeted anti-cancer drugs in China

作　　者：陈晓媛[1] 张虹[1] 高晨燕[1] 杨志敏[1] 

机构地区：[1]国家食品药品监督管理局药品审评中心,北京100038

出　　处：《中国新药杂志》2011年第17期1615-1619,共5页Chinese Journal of New Drugs

摘　　要：小分子靶向抗肿瘤药物是当前国内外创新药研发的热点。在过去十年里有多个产品上市,并有数十个产品处在研发中。本文对近年来我国小分子靶向抗肿瘤药物研发和申报情况进行回顾与分析,进而对此类药物临床研究中的相关问题进行了探讨。Molecular targeted small-molecule anti-cancer drugs have been a worldwide focus in research and development of innovative drugs in recent years. There are several products into market in the past ten years, and several tens are still in developing phases. Here, we reviewed and analyzed the applications of such new small- molecule compounds that were received and approved by SFDA between Jan 2005 and July 2011. Furthermore, we discussed some related problems of developing strategy including clinical study for this drug type.

关 键 词：小分子靶向抗肿瘤药 研发 申报 临床研究 

分 类 号：R979.1[医药卫生—药品]