中国改良型新药的特点及未来发展

化学药品新注册分类重新定义了新药及仿制药的概念,新药强调全球新,包括创新药和改良型新药,其中改良型新药是对已上市药品的改进,强调"优效性",具有高成功率、高回报、低风险、生命周期长等优势,已成为全球新药研发的主流.中国新药的改良应立足临床需求,开展差异化研究,获得具有明显临床优势的制剂,更好地服务于临床.本文阐述了中国改良型新药的范畴及特点,案例剖析了全球重磅级改良型新药研发历程,分析了改良型新药研发的机遇与挑战,以期为中国改良型新药的未来发展提供思路.

Characteristics and future development of modified new drugs in China

New registry classifications of chemical drugs redefined the concepts of new drugs and generic drugs. New drugs emphasize the international innovation including innovate new drugs and modified new drugs. Modified new drugs are improvement of drugs already on the market to achieve superior efficacy. With the advantages of high success rate,high return,low risk and long life cycle,modified new drugs have become the mainstream of new drugs research and development in the world. Modified new drugs R&D in China should be based on clinical demand and focused on the differentiation research in order to obtain new preparations with signif-icant clinical advantages to better serve the clinical practise. This paper states the concept and characteristics of modified new drugs in China,makes case analysis and shares the development history of blockbuster modified new drugs in the world,clarifies the opportuni-ties and challenges and provides ideas for the future development of modified new drugs in China.