[1]阿丽塔,穆鑫,唐小利,等.1984~2014年治疗性生物药物发展历程及展望[J].中国药理学通报,2015,(10):1356-1362.[doi:10.3969/j.issn.1001-1978.2015.10.007]
 Alita,MU Xin,TANG Xiao li,et al.Development of therapeutic biologics from 1984 to 2014[J].Chinese Pharmacological Bulletin,2015,(10):1356-1362.[doi:10.3969/j.issn.1001-1978.2015.10.007]
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1984~2014年治疗性生物药物发展历程及展望()
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《中国药理学通报》[ISSN:/CN:]

卷:
期数:
2015年10期
页码:
1356-1362
栏目:
讲座与综述
出版日期:
2015-10-20

文章信息/Info

Title:
Development of therapeutic biologics from 1984 to 2014
作者:
阿丽塔12穆鑫34唐小利2杜冠华34武志昂1
1. 沈阳药科大学工商管理学院,辽宁 沈阳110016;2. 中国医学科学院医学信息研究所信息服务部,北京100005; 3.中国医学科学院北京协和医学院药物研究所,北京100050;4.中国药理学会,北京100050
Author(s):
Alita12MU Xin34 TANG Xiaoli2 DU Guanhua34WU Zhiang1
1.School of Business Administration Shenyang Pharmaceutical University,Shenyang110016, China; 2.Dept of information service, Institute of Medical Informatics, Chinese Academy of Medical Science,Beijing100005, China; 3.Institute of Material Medica, Chinese Academy of Medical Science and Peking Union Medical College, Beijing100050, China; 4.Chinese Pharmacological Society, Beijing100050, China
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
Keywords:
US Food and Drug Administration therapeutic biologicsbiopharmaceuticals Firstinclassresearch & developmentnovel drugs
分类号:
R05;R915
DOI:
10.3969/j.issn.1001-1978.2015.10.007
文献标志码:
A
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。
Abstract:
This article is to analyse the development of therapeutic 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 nature of the drugs. The results showed that from 1996 the therapeutic 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 metabolic diseases, blood system diseases, skeletal muscle system diseases. Antibody has become the dominant of therapeutic biologics. Antibody is widely used in the treatment of cancer, digestive diseases, immune diseases, respiratory diseases, urinary diseases, skeletal muscle diseases, etc.

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更新日期/Last Update: 1900-01-01