摘要
本文全面介绍了2015年FDA批准上市新药的总体情况,并就新药研发的现状与趋势进行分析。从药物研发市场的热点治疗领域(肿瘤、心血管疾病、代谢疾病、自身免疫系统疾病和感染性疾病等)及其罕见病领域,针对2015年上市的部分首创新药以及研发后期的重磅潜力药物,着重从作用机制、里程碑意义以及潜在的市场表现等角度进行评述。
The general situation of new drugs approved by FDA for drug evaluation and research in 2015 was introduced,and the status and trends of new drug research and development were analyzed. According to the key therapeutic categories such as oncology,cardiovascular disease,metabolic disease,autoimmune diseases,and infectious disease as well as the rare disease,some of the first-in-class drugs launched in 2015 and some investigational new drugs in the field of priorities treatment in the late-stage development were elaborated in this paper.These drugs were introduced from their mechanism,milestone significance,and potential market performance.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2016年第6期601-621,638,共22页
Chinese Journal of New Drugs
基金
中央高校基本科研业务费专项基金项目(JKQR2013001)
关键词
上市新药
2015
新分子实体
生物制品
突破性治疗认定
抗肿瘤药物
代谢疾病
罕见病
new drugs coming into the market
2015
new chemical entity
biological product
break-through therapy designation
ant-tumor agent
metabolic diseases
rare disease
