中国食品药品监管Issue(6)：16-27,12.DOI:10.3969/j.issn.1673-5390.2026.06.002
临床价值导向下的AI制药范式转型:从FIC到FID的二元模型协同路径
Paradigm Shift in AI-Driven Drug Discovery under Clinical Value Orientation:A Synergistic Path of the Dual Model from FIC to FID
摘要
Abstract
The innovative drug industry is a strategic pillar industry in China.The Regulations for the Implementation of the Drug Administration Law explicitly emphasize a"clinical value-oriented"approach.Taking unmet clinical needs as the starting point and patient benefit as the endpoint has become an international consensus;however,constrained by bottlenecks in the elucidation of disease pathogenesis,this concept has long failed to be translated into an actionable paradigm.By integrating AI technologies,this paper proposes a paradigm shift from first-in-class(FIC)to first-in-disease(FID).The core of this reconstruction is to shift the criterion of pioneering status from molecular structural novelty to therapeutic value in disease treatment.It demonstrates how AI and multi-omics enable systematic dissection of disease pathogenesis and operationalize a disease-driven R&D logic and embed this new paradigm within China's framework for high-quality innovative drug industrial development.From the dimensions of"precision manufacturing"and"scientific decision-making,"this paper categorize AI-driven computational tools into two modules:chemistry models,which focus on molecular design,and biological models,which focus on the dissection of disease pathogenesis.This classification constitutes a functional abstraction aligned with the entire R&D chain.On this basis,the paper proposes that"the synergistic advancement of the dual models is the critical pathway to implementing the clinical value-oriented approach."It then analyzes the pain points of the R&D-clinical disconnect arising from insufficient synergy,and offers multidimensional recommendations to support the high-quality development of the industry.关键词
人工智能制药/临床价值导向/FIC/FID/二元模型/化学模型/生物模型Key words
artificial intelligence for drug discovery/clinical value orientation/first-in-class(FIC)/first-in-disease(FID)/dual model/chemical model/biological model分类
医药卫生引用本文复制引用
赵宇,江旻,丛斌,王刚,张春明,张静,连云波,张堃..临床价值导向下的AI制药范式转型:从FIC到FID的二元模型协同路径[J].中国食品药品监管,2026,(6):16-27,12.基金项目
中国工程院院地合作项目(2025-DFZD-22) （2025-DFZD-22）
北京市科技计划项目(Z231100004623006) （Z231100004623006）
北京市自然科学基金-海淀原始创新联合基金(L232032) （L232032）
