单克隆抗体药物风雨飘摇20年  

The Rocky Road of Therapeutic Antibody Development Over 20 Years

作　　者：吴卫星[1] 杨宁[1] 张毓[2] 王小宁[3] 

机构地区：[1]军事医学科学院野战输血研究所,北京100850 [2]北京大学医学部免疫系,北京100083 [3]华南理工大学生物科学与工程学院,广东广州510640

出　　处：《生物技术通讯》2006年第5期764-767,共4页Letters in Biotechnology

摘　　要：1986年,美国FDA批准了第一个单克隆抗体药物上市。迄今,全世界共有21个治疗用抗体药物被批准上市,实现300亿美元的销售额,促进了国际、国内抗体药物的开发热潮。巨大的市场前景和亟待克服的技术问题及壁垒并存的现实不可避免地引发抗体药物的新一轮技术革命,而其结果又将毫无疑问地改变抗体药物的市场格局。抗体药物的研究和开发能否真正成为中国生物技术药物开启国际市场大门的新钥匙?何为我们首选的切入点?我们又该如何形成自己的特色和竞争优势?回顾国际抗体药物20年风雨飘摇的发展经历,总结其中的经验教训,无疑会给我们一些有益的启示。The first therapeutic antibody received FDA approval in 1986. Since then, 20 additional products have been licensed world-wide. This not only creates a 30 billion dollar business, but also catalyzes a rush in antibody drug development both overseas and in China. Driven by the huge market potential and the anxiety for breakthrough in current technical barriers, a new round of technical renovation is looming, and the result is expected to shuffle the entire field. This provides a challenge as well as an opportunity for the Chinese biotechnology industry. What are our priorities, and how shall we develop our own edges in the competition？ Lessons from antibody drug development over the last 20 years should be of great value for our strategic planning.

关 键 词：抗体药物 适应证 研发趋势 

分 类 号：Q813.2[生物学—生物工程] F407.7[经济管理—产业经济]