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治疗性单克隆抗体药物的现状及发展趋势

The Status Quo and Development Trend of the Therapeutic Monoclonal Antibody Drugs

【作者】 王志明高健李耿

【Author】 WANG Zhi-ming GAO Jian LI Geng(NCPC New Drug Research and Development Co.,Ltd.State Key Laboratory of Antibody Drug Development,Shijiazhuang 050015,China)

【机构】 华北制药集团新药研究开发有限责任公司抗体药物研制国家重点实验室

【摘要】 治疗性单克隆抗体药物经历了三十多年的发展,已经成为生物医药的最重要组成部分之一。在疾病治疗上具有广阔的应用前景,成功用于治疗肿瘤、自身免疫性疾病、感染性疾病和移植排斥反应等多种疾病。截至2012年已有29种治疗性单克隆抗体药物通过FDA审批并上市销售。治疗性单抗的安全性和有效性很大程度上由其作用的靶点决定,上市和在研的单抗药物有些靶向相同的靶点,有些有自己独特的作用靶点,新的作用靶点也在不断出现。以治疗性单抗的作用靶点为切入点,对目前上市销售和研发中的此类药物进行了简要总结。详述了肿瘤坏死因子α、白细胞分化抗原20、表皮生长因子受体及血管内皮生长因子等4种靶点的特点及相关单克隆抗体药物的情况,并对我国单抗药物的现状进行了分析,提出未来发展对策。

【Abstract】 After more than 30 years of development,monoclonal antibodies have become an important class of clinical drugs.Currently,these antibody drugs are used to treat many kinds of diseases,such as cancer,autoimmune diseases,infectious diseases and transplant rejection reactions.Ended in 2012,there are 29 kinds of therapeutic monoclonal antibody drugs through the FDA approval and on sale.And in 2011,there were more than 1000 kinds of antibody drugs undergoing clinical trials in the European Union or the United States,of which about 164 kinds of antibodies in clinical phase III trials.The safety and efficacy of therapeutic monoclonal antibody drug is largely decided by the target.Some monoclonal antibody drugs in research have the same targets with the antibodies on sale,and some have the unique targets.At the same time,more and more new targets are being found.There are four kinds of the most popular targets of research: tumor necrosis factor-α,cluster of differentiation 20,epidermal growth factor receptor and vascular endothelial growth factor.Detailed review which focuses on the different targets of the monoclonal antibody drugs,whether in research or on sale,is expected to provide valuable references for the monoclonal antibody drug development trend.The status quo of monoclonal antibody drug in our country was discussed,and the development strategies in the future were proposed.

【关键词】 单克隆抗体; 肿瘤坏死因子α; 白细胞分化抗原20; 表皮生长因子受体; 血管内皮生长因子;

【Key words】 Monoclonal antibody TNF-α CD20 EGFR VEGF;

【分类号】R392.116;R341;R392.114;

【基金】 国家“863计划”资助项目(2012AA02A306)

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