抑郁症是全球致残的首要原因之一，传统诊断依赖《精神障碍诊断与统计手册》（DSM-5）症状学标准，存在误诊率高（约30%～40%）和治疗延迟（平均延迟8～10年）的问题。生物标志物作为反映生物体生理、病理或环境暴露状态的重要指标，近年来在医学诊断、药物研发和个性化医疗等领域发挥着越来越关键的作用。系统综述近年来国内外抑郁症生物标志物研究进展，并分析中国、美国、欧洲药监政策对相关药物研发的推动作用，为相关领域的研究者和政策制定者提供全面的参考，建立符合中国人群特征的生物标志物评价体系。

Depression is one of the leading causes of disability worldwide. Traditional diagnosis relies on the symptom criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders（DSM-5）, which has led to high misdiagnosis rates（approximately 30%—40%） and delayed treatment（on average, 8—10 years）. Biomarkers, as important indicators reflecting the physiological, pathological, or environmental exposure status of organisms, have played an increasingly critical role in medical diagnosis, drug development, and personalized medicine in recent years. This article systematically reviews the progress of biomarker research on depression both domestically and internationally, and analyzes how regulatory policies in China, the United States, and Europe have promoted related drug development. It aims to provide comprehensive references for researchers and policymakers in these fields, establishing a biomarker evaluation system that aligns with the characteristics of the Chinese population.

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