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Gene therapy drugs based on adeno-associated virus (AAV) have become the most widely used viral vectors for in vivo gene therapy in clinical applications. Until July 2025, nine AAV-based gene therapy drugs have been approved globally, with many more in research or clinical trials. This article analyzes the basic characteristics, adverse reactions, and risk management strategies of AAV gene therapy drugs, aiming to provide valuable insights for risk assessment and mitigation in this field.

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腺相关病毒（AAV）基因治疗药品已成为临床应用最广泛的体内基因治疗病毒载体类型。截至2025年7月，全球共有9个AAV基因治疗药品上市，另外有多款产品进入研发和开展临床试验的阶段。本文基于AAV基因治疗药品的基本信息、不良反应、风险管理等多个方面进行研究分析，旨在为AAV基因治疗药品的风险认识和风险管理提供有益参考。

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赵晨阳（1990-），女，副研究员，主要从事细胞和基因治疗药品审评与监管科学研究

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赵晨阳（1990-），女，副研究员，主要从事细胞和基因治疗药品审评与监管科学研究

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