从市场角度看我国新药的发展

Development of new drugs in China from the market point of view

回顾2008-2013年间获得3类及以上新药证书的药品市场情况,获批3类及以上新药总体上获得了市场成功,其价格结构趋于合理,但可及性却出现了一定的问题。从市场的角度分析,1、2类新药是新药市场发展的主要推动力,但企业自身实力和相关药品政策却不利于3类及以上新药尤其是1、2类新药的有效普及。对此,我国应当以临床需求引导新药审评审批、加快推进新药价格机制改革和改善新药使用环境等方式,提升我国医药行业新药研发尤其是创新性药物研发的积极性,为我国药品创新发展提供相关建议。

The drug market situation of category 3 or above type of new drug certificate from 2008 to 2013 were reviewed. The approved category 3 or above type of new drugs win market success on the whole,their price structure are more reasonable,but their accessibility has certain problems. From the market point of view,the category 1 or above of new drugs are the main driving force in the development of new drug market,but their own strength and the related drug policy are unfavorable to the category 3 or above type of new drugs,especially for the effective penetration of the category 1 or above of new drugs. Thus,we should guide the new drug approval with clinical requirement,accelerate their pricing mechanism reform,and improve their application environment. Based on the above methods,new drugs R＆D of Chinese pharmaceutical industry will be promoted,especially for the enthusiasm of innovative drug R＆D. In this paper,we provided some relative suggestions for the drug innovation and development in China.