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Safety analysis and risk management of gene therapy drugs based on adenovirus vector technology
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Chen-yang ZHAO, Shuang LU
Chinese Journal of Clinical Pharmacology | 2025, 41(23) : 3438 - 3446
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Chinese Journal of Clinical Pharmacology | 2025, 41(23): 3438-3446
Drug Evaluation and Administration
Safety analysis and risk management of gene therapy drugs based on adenovirus vector technology
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Chen-yang ZHAO, Shuang LU
Affiliations
  • Center for Drug Evaluation, National Medical Products Administration, Beijing 100076, China
Published: 2025-12-17 doi: 10.13699/j.cnki.1001-6821.2025.23.020
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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.

gene therapy  /  adeno-associated virus  /  safety  /  risk management
Chen-yang ZHAO, Shuang LU. Safety analysis and risk management of gene therapy drugs based on adenovirus vector technology[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (23) : 3438 -3446 . DOI: 10.13699/j.cnki.1001-6821.2025.23.020
Year 2025 volume 41 Issue 23
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doi: 10.13699/j.cnki.1001-6821.2025.23.020
  • Receive Date:2025-08-29
  • Online Date:2026-08-05
  • Published:2025-12-17
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  • Received:2025-08-29
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    Center for Drug Evaluation, National Medical Products Administration, Beijing 100076, China
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表12种不同金属材料的力学参数

Family
属数
Number of
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种数
Number of
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占总种数比例
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种数
Number of
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Percentage of total
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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