中国创新药鼓励政策改革进展与成果  

Progress and achievements of incentive policy reform for innovative drugs in China

作　　者：王奇巍 叶亚婧 郭文[2] WANG Qi-wei;YEYa-jing;GUO Wen(China State Institute of Pharmaceutical Industry,Shanghai 200040,China;China National Pharmaceutical Industry Information Center,Shanghai 200040,China)

机构地区：[1]中国医药工业研究总院,上海200040 [2]中国医药工业信息中心,上海200040

出　　处：《中国新药杂志》2024年第13期1297-1302,共6页Chinese Journal of New Drugs

摘　　要：创新是医药行业的主旋律,创新药的研发进展与成果又是医药产业创新发展水平的重要标志。本文系统梳理了我国2015年以来针对创新药发展的重要鼓励政策,发现国内的创新生态发生了巨大变化。创新药的定义从“中国新”转变成了“全球新”,创新主体的活力也得到释放,创新药研发立项、临床试验、审评审批、沟通机制、专利保护、医保准入、终端落地、资本助力等方面都较2015年前有了明显改善。在此利好背景下,国内的创新药研发成果可喜,获批通用名数量增多,国产创新药比例增大,各终端市场稳步增长,通过谈判纳入医保的数量逐年增多。但未来创新药政策改革仍需关注多链条协同和细化落地,与此同时也应密切关注政策实施可能带来的副作用,做好及时调整工作。Innovation is the main theme of the pharmaceutical industry, and the progress of innovative drug development is in turn an important symbol of the innovative ability of the pharmaceutical industry. This paper systematically composes the important incentive policies for the development of innovative drugs since 2015 in China, and finds that the domestic innovation ecology has changed dramatically. The definition of innovative drugs has shifted from “new in China” to new “in the world”. The vitality of innovative subjects has been released, with significant improvements in innovative drug R&D, clinical trial, review and approval, communication mechanism, patent protection, medical insurance access, terminal landing, and capital assistance compared to that before 2015. Under this favorable background, the number of approved innovative drugs and the proportion of domestic products have increased, the market size of different sales terminal has grown steadily, and the number of innovative products included in the national medical insurance drug list has increased year by year. In the future, more attention should be paid to multi-chain synergy, policy implementation details, possible side effects brought by the policy implementation, and the measures we could take to avoid these side effects.

关 键 词：创新药 鼓励政策 改革进展 改革成果 

分 类 号：R95[医药卫生—药学]