As a unique model for the development of new traditional Chinese medicine (TCM) drugs, syndrome TCM new drugs adhere to the principle of consistency in “theory, method, prescription, and medicine,” making them the category of TCM compound preparations that best reflect TCM thinking and clinical value. However, since syndrome new drug research is still in its exploratory stage, the lack of authoritative syndrome diagnostic standards and the singularity of efficacy evaluation methods limit its credibility in clinical research. This makes it difficult to provide strong evidence for new drug approval. This article reviews the development history of syndrome new drug research, analyzes the bottlenecks and challenges faced in its market transformation, and proposes preliminary ideas and suggestions for constructing clinical evaluation approaches for syndrome new drugs. 

2015年后, 随着药品审评审批优化、人用药品技术要求 国际协调理事会(The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, ICH)指导原则推行以及药品上市许可持有人制度落地等综 合改革措施的确立, 我国医药产业的发展重心和研发生态发 生了彻底的转变. 历经近10年的探索, 我国药品监管体系逐 步与国际接轨; 而且, 利好的政策环境也为新药研发营造了 丰沃土壤. 在新的发展阶段, 如何激活“源头创新”, 实现从创 新探索到创新突破的跨越, 已成为我国创新药研发亟需思考 的重要课题. 中医药作为具有原创优势的杰出代表, 不仅是 独特的卫生资源, 也是潜力巨大的经济资源和科技资源. 在 过去几十年间, 已有许多实践证明了中药在治疗多种人类疾 病方面的良好成效. 其中, 证候类新药是中药注册中的独有 模式, 相较于其他类别, 该模式更加符合中医对疾病的认识 规律和诊疗路径. 然而, 由于证候类新药研发面临诸多挑战, 迄今为止尚无该类药物获批上市. 为进一步建立完善符合中 药特点的注册管理制度和技术评价体系, 我们需要运用原创 理论讲好原创实践, 并摸索出一条适合中医药自身的发展 之路.