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1.前言继重组蛋白领域的商业成功之后,治疗性单克隆抗体正掀起生物技术工业近二十年来的第二次创新高潮。2002年,全球治疗性单克隆抗体市场较2001年增长37%,达到了54亿美元。其中嵌合型单克隆抗体占有绝对领先地位,它们的年增长率高至43%,销售额为38亿美元:其次是人源化单克隆抗体,它们的销售额超过14亿美元,年增长率约29%。目前,世界治疗性单克隆抗体临床开发管线产品数有132个,后者除70%属人源化(占42%)和全人型(占28%)单克隆抗体这一显著特征之外,另估计它们中的16个产品能在2004～2008年间获得批准。而随着治疗性单克隆抗体现有产品销售额持续增长及上述又一轮新产
1. Introduction Following the commercial success in the field of histone proteins, therapeutic monoclonal antibodies are setting off a second wave of innovation in the biotechnology industry for nearly two decades. In 2002, the global therapeutic monoclonal antibody market increased by 37% over 2001 to reach 5.4 billion U.S. dollars. Among them, chimeric monoclonal antibodies hold the absolute leading position. Their annual growth rate is as high as 43% with sales of 3.8 billion US dollars: followed by humanized monoclonal antibodies with sales of more than 1.4 billion US dollars, annual growth rate About 29%. Currently, the world’s therapeutic monoclonal antibody clinical development pipeline product number is 132, the latter in addition to 70% of humanized (42%) and all-human (28%) monoclonal antibody this significant feature, It is also estimated that 16 of these products will be approved between 2004 and 2008. With the current sales of therapeutic monoclonal antibodies continued to grow and the above round of new production