美国食品与药物管理局(FDA)的血液制品顾问委员会已建议批准美国Miles公司研制的重组因子Ⅷ制剂(商品名Kogenate)进入市场。据悉,全世界约有2.5万人因缺少因子Ⅷ而患有血友病,其中美国有1.2万例。一个血友病患者每年需要价值5万美元的凝血因子。作为血清来源的凝血因子的代用品必须消除传播HIV感染的危险性。美国绝大多数血友病患者因使用污染血制品而感染AIDS病毒。如果FDA批 The U.S. Food and Drug Administration (FDA) Blood Products Advisory Committee has recommended approval of the introduction of the recombinant Factor VIII formulation (trade name Kogenate) developed by Miles in the US into the market. It is reported that about 25,000 people worldwide suffer from hemophilia due to the lack of Factor VIII, of which 12,000 are in the United States. A person with hemophilia needs a $50,000 worth of clotting factor each year. Substitution of blood clotting factors as a source of serum must eliminate the risk of transmitting HIV infection. The vast majority of hemophilia patients in the United States are infected with the AIDS virus due to the use of contaminated blood products. If FDA approved