在第一个生物制剂——胰岛素获准上市后不到20年的时间里,新一代产品正在取代蛋白质和酶在生物技术领域的替代治疗作用。目前已有84个生物制剂可用于医疗,这使得全世界约有6000万病人能够广为受益,其全球市场的总额目前已超过120亿美元。据估计,当前约有500个生物制剂正处于临床试验阶段,从而确保了生物制剂这一部分将会继续增长。然而,早期批准的重组产品一直是替代蛋白,它显示 In less than 20 years after the first bioproduct, Insulin, was approved, a new generation of products is replacing alternative therapeutic uses of proteins and enzymes in biotechnology. To date, 84 biologics have been made available for medical use, which has benefited about 60 million patients worldwide, with a total global market now worth over 12 billion U.S. dollars. It is estimated that at present about 500 biological agents are in clinical trials, thus ensuring that this part of biological agents will continue to grow. However, the early approved recombinant product has been a surrogate protein, which it shows