生物制药的现状和未来（二）：发展趋势与希望

随着基因组和蛋白质组研究的深入,越来越多的与人类疾病发展相关的靶标被确定,使得我们能够研发更精确的药物来防治这些疾病。这意味着生物制药将有更多机会获得突破性进展,最终将使更多更好的生物技术药物被批准上市。综述了生物制药发展的几个趋势,主要有:(1)哺乳动物细胞表达的产品将在相当长的时间内占统治地位;(2)治疗性抗体将会是生物制药领域第二次创新高潮;(3)越来越多分子量大、结构复杂的功能蛋白将被开发成生物技术药物,尤其是用于治疗遗传性疾病的药物;(4)对已批准上市的生物技术药物的化学修饰尤其是PEG化以改善药物性能;(5)通过某些药物的定点突变获得第二代新生物技术药物,如胰岛素、EPO和t-PA的突变体;(6)组织工程、细胞治疗和基因治疗充满了机遇和挑战。

The Present and the Future of Biopharmaceuticals(2):Trends and Prospects

Both genomics and proteomics are contributing to understanding and determining more targets which involved in the development of human disease, and will enable us to develop more precise medicine to treat and prevent more diseases. This means there will be more opportunities for biopharmaceutical breakthroughs, eventually, more and better biomedicines will be approved. There are several trends in development for biopharmaceuticals: (1) the products expressed by mammalian cell will dominate the biopharmaceutical industry for a long time. (2)Therapeutic antibodies represent the second wave of innovation created by the biopharmaceutical industry. (3)More and more macromolecular and functional proteins with complex structure will be developed into therapeutic medicines, especially for treatment of hereditary diseases. (4) Chemical modifies, especially PEGylation of approved biomedicines to improve efficacy is one of the trends in development of new biotech drugs. (5) Site-directed mutagenesis of some biotech drugs to get second generation biomedicines, such as mutants of EPO, insulin and t-PA. (6)Tissue engineering, cell therapy and gene therapy are full of opportunities and challenges.