中文摘要：

单克隆抗体技术的问世,使研究和生产治疗性单抗药物成为现实。随着基因工程技术的发展,新型的重组抗体技术也随之而生。人们可以利用DNA重组技术对鼠源抗体进行人源化改造、构建合成或半合成抗体库及噬菌体抗体库,从中筛选获得人源抗体,甚至利用转基因小鼠直接获得人源抗体。抗体药物发展的趋势也从鼠源、人-鼠嵌合、人源化到全人源。近年获得批准的抗体药物以全人源为主。1996年至2008年间进入临床研究的人源化单克隆抗体中45%用于治疗肿瘤,28%个用于治疗免疫紊乱。抗体药物的发展进入研发、回报的良性循环,成了国际制药业争夺的焦点。文章就治疗性抗体发展的历史、现状、市场及未来展望作了简要综述。

英文摘要：

The advent of monoclonal antibody technology actualized the research and manufacture of monoclonal antibodies.With the development of gene engineering,recombinant genetic antibody came true.With the aid of recombinant DNA technology,murine antibody could be humanized,and some synthetic or semisynthetic human antibody library or phage displayed human antibody library have been constructed.Therefore,human antibody could be obtained by screening from such libraries.Transgenic mouse is another source of human antibody.The class of therapeutic antibodies are varied from murine antibody to human-mouse chimeric antibody,to humanized antibody and finally human antibody.Most of the recently approved therapeutic antibodies are derived from human antibody.From the year of 1996 to 2008,45 percent of the monoclonal antibodies in clinical trial are anti tumor antibodies,and 28 percent are for immunologic derangement.In conclusion the development of therapeutic antibodies has run into a virtuous cycle from RD to return,which lead to a hotspot in the international pharmaceutical industries.In this article,the history,market,problem and perspective of therapeutic antibodies are highlighted.