脑血管病创新药物研发的问题与对策

Problems and strategy of drug innovation for cerebrovascular diseases

随着我国患者医疗需求的快速增长,新药专利期限缩短、传统市场的增长再下降、新的竞争者越来越多以及健康预算整体压缩等原因致使我国医药企业的新药研产率日益下降。每年脑血管药物占直接住院医疗费用的200亿,其新药研发面临着巨大压力:第一,已知的药物靶点已经被开发很多。第二,各国的药审部门标准越来越严格。第三,从药物研发到临床评价周期长。因此,脑血管病创新药物研发必须顺应4个新的趋势来加快发展该领域的新药研发:第一,新的靶点的发现必须要依赖基础研究。第二,脑血管病的疗效标准在不断调整。第三,循证医学对临床试验要求越来越高。第四,系统生物学对脑血管药物研发的影响越来越大。

The successful rate of new drug research and development in Chinese pharmaceutical companies is lower and lower.The reasons include the medical need of patients is rapidly growing;the term of new drug patent is short;the growth of traditional pharmaceutical market is slow;new competitors are increasing,and the health budget is cut.The annual direct in-patient medical cost of drugs for cerebrovascular diseases is 20 billion.The drug development for cerebrovascular diseases has many difficulties：（1） many known drug targets have been well developed,so new targets are needed.（2） approval standards of new drugs around the world become much stricter.（3） the time gap between drug research and clinical evaluation is very long.Therefore,the research and development of new drugs for cerebrovascular diseases will follow the following four trends：（1） new drug target discovery should base on basic research.（2） the efficacy standard for cerebrovascular diseases will be adjusted.（3） evidence based medicine demands higher level of clinical trial.（4） systems biology has much deeper influence on new cerebrovascular drug discovery and development.