摘要
为了全面系统了解1984-2014年全球生物药物的发展历程,掌握30年来生物药物的发展脉络、上市药物特点、研发管线布局等信息,该文以Drugs＠FDA、中国食品药品监督管理总局数据库、PubMed、Embase.com、ClinicalTrail.Gov等数据库为数据来源,系统采集国内外上市和在研的生物药物信息.对已经上市和在研的生物药物从创新程度、药物适应症分布、药物化学特性、药物研发阶段等方面进行了深入分析.结果表明全球生物药物在1996年以后开始快速发展,2001～2005年是生物药物成果最为显著的阶段.肿瘤、免疫系统疾病、内分泌和代谢疾病、血液系统疾病、骨骼肌系统疾病是生物药物研究的重点领域,上市药物较多.目前抗体已经发展成为治疗性生物药物的主宰药物,在肿瘤、消化、免疫、呼吸、泌尿、骨骼肌疾病、疾病诊断等不同领域广泛应用.
This article is to analyse the development of therapeu-tic biologics from 1984 to 2014. Data were obtained from the Drugs @ FDA, PubMed, Embase. com and ClinicalTrail. Gov. Descriptive analyses were used to classify therapeutic biologics by level of innovation,therapeutic category and the chemical na-ture of the drugs. The results showed that from 1996 the thera-peutic biologics entered the fast development period, especially from 2001 to 2005. The 125 therapeutic biologics focus on the treatment of tumor, immune system disease, endocrine and met-abolic diseases, blood system diseases, skeletal muscle system diseases. Antibody has become the dominant of therapeutic bio-logics. Antibody is widely used in the treatment of cancer, di-gestive diseases, immune diseases, respiratory diseases, urinary diseases, skeletal muscle diseases, etc.
出处
《中国药理学通报》
CAS
CSCD
北大核心
2015年第10期1356-1362,共7页
Chinese Pharmacological Bulletin
基金
NSTL面向重大新药创制专项专业化信息服务(No 2013XM51)
关键词
美国FDA
生物药物
生物技术药物
首创性新药
研发
新药
US Food and Drug Administration
therapeutic biologics
biopharmaceuticals
First-in-class
research & development
novel drugs
