国际新生物技术药开发研究进展

Progress in the international development of biotechnology medicines

对目前国际上生物技术药物的开发研究现状和2008年处于临床开发研究阶段的633种新生物技术药按产品类型与疾病类型进行归纳和概括性介绍,并与2006年同类新药研究情况进行对比分析,重点针对治疗哮喘、自身免疫疾病、HIV/艾滋病和感染性疾病、皮肤病和血液病等的新生物技术药进行分析和介绍。与2006年的418种新生物技术药相比,2008年处在开发研究阶段的新生物技术药明显增加,增长率为51.44%。经比较和分析得出结论,处于临床开发研究阶段的单抗在治疗肿瘤、自身免疫疾病、呼吸系统疾病、心血管病、HIV/艾滋病、自身免疫疾病和血液病等的新生物技术药中占较大的比例,并且治疗肿瘤、感染性疾病、HIV/艾滋病、自身免疫疾病和心血管病的新生物技术药占2008年处于临床开发阶段的新生物技术药的74.06%(534/721)/76.37%(737/965),它们应是未来几年生物技术药的主要研发方向。

We reviewed product category and therapeutic category,outlined the status quo of development of biotechnology medicines,and briefly induced the 633 new biotechnology medicines internationally developed to treat various diseases in 2008.We especially emphasized the new biotechnology medicines,such as those to treat asthma,autoimmune diseases,HIV/AIDs,infectious diseases,skin disorders and blood disorders.Compared with the 418 new biotechnology medicines developed in 2006,the number of the biotechnology medicines has increased greatly （by 51.44% ） in 2008. Based on the comparison and analysis,the conclusion is that monoclonal antibodies （MAbs） eount a higher percentage in the biotechnology medicines developed internationally ,which are used to treat cancer, autoimmune disorders, respiratory diseases, cardiovascular diseases, HIV/AIDs and blood disorders. The biotechnology medicines for cancer, infeetious diseases, HIV/AIDs and cardiovascular diseases count for 74. 06% （534/721）/76.37% （737/965） in 2008. They will be the main direction in development of biotechnology medicines in the future few years.