摘要
本文首先全面介绍了2017年FDA批准上市新药的总体概况,并就新药研发的现状与趋势进行了分析。然后按照当前新药研发的热点领域,分别从基因疗法、肿瘤治疗、免疫治疗、神经退行性疾病以及低成瘾性的疼痛治疗药物等重点领域,对2017年上市的部分新药以及研发后期的2018年重磅潜力药物,着重从作用机制、临床研究以及潜在的市场表现等角度进行介绍和评述。
The general situation of novel drugs approved by FDA center for drug evaluation and research in2017 was firstly introduced concerning the total numbers and the technological innovation,and the status quo and trend of drug research and development was analyzed as well. According to the hot fields of new drug research and development,from the gene therapy,tumor therapy,immune therapy,neurodegenerative diseases and less-addictive pain killer and other key areas,respectively,part of the new launches in 2017 and the most promising late-stage candidates in 2018 which have the potential to be blockbusters were introduced and reviewed in this paper,mainly from the perspective of mechanism of action,clinical research and the potential market performance.
作者
陈玲
周新源
张静
黄文龙
CHEN Ling;ZHOU Xin-yuan;ZHANG Jing;HUANG Wen-long(China Pharmaceutical University, Nanjing 210009, China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2018年第13期1449-1459,共11页
Chinese Journal of New Drugs
基金
中央高校基本科研业务费专项基金资助项目(2632017RW07)
中央高校基本科研业务费校级平台基地项目"药学知识创新机构服务中心"资助项目(2016RPT003)