在对目前中国新药创新现状的认识的基础上,对中国新药研发模式的转变进行探讨。提出中国新药研发模式逐步从仿制(Me-too)/仿创(Me-better)到首创(First in class)转变的必然性,以及企业在进行新药研发模式转变的过程中,面临的包括选题和管理决策的科学性的挑战及解决方案。 Based on the current understanding of the status quo of new drug innovation in China, the paper explores the transformation of the R & D mode of new drugs in China. Proposed the inevitability of China’s new drug research and development mode gradually changing from Me-too / Me to better to First in class, as well as the inevitability of enterprises changing their R & D mode of new drugs, Scientific Management Challenges and Solutions.