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Advances in non-clinical safety evaluation of mRNA drug delivery carriers
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Yi-kun ZHANG, Tian-tian HOU, Zi-yi JIN, Ying HUANG*, Xing-chao GENG*
Chinese Journal of New Drugs | 2025, 34(17) : 1814 - 1819
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Chinese Journal of New Drugs | 2025, 34(17): 1814-1819
Advances in non-clinical safety evaluation of mRNA drug delivery carriers
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Yi-kun ZHANG, Tian-tian HOU, Zi-yi JIN, Ying HUANG*, Xing-chao GENG*
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  • National Center for Safety evaluation of Drugs, National Institutes for Food and Drug Control, Beijing Key Laboratory of Quality Control and Non-clinical Research and Evaluation for Cellular and Gene Therapy Medicinal Products, Beijing 100176, China
Published: 2025-09-15 doi: 10.20251/j.cnki.1003-3734.2025.17.004
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Since the outbreak of the coronavirus epidemic, how to deal with sudden large-scale infectious diseases has become a global research hotspot. The first mRNA vaccine BNT162b2, which was urgently approved by the US FDA, has shown good efficacy in dealing with the novel coronavirus. It not only provides new solutions for sudden infectious diseases but has also attracted widespread attention in the field of drug research and development. However, the molecular structure of mRNA is unstable, and needs to be delivered to the target site with the support of carriers to exert its efficacy. The composition of mRNA drug delivery carrier is complex and is the main factor causing adverse drug reactions, which may lead to different types of adverse drug reactions, such as immune responses and inflammatory reaction. This paper mainly discusses the potential safety risks in mRNA drug-related carriers, as well as the consideration points and reference cases in non-clinical safety evaluation, so as to provide references for exploring and building scientific safety evaluation methods for mRNA drugs.

mRNA drug  /  carrier  /  toxicity  /  non-clinical safety evaluation  /  adverse reaction
Yi-kun ZHANG, Tian-tian HOU, Zi-yi JIN, Ying HUANG, Xing-chao GENG. Advances in non-clinical safety evaluation of mRNA drug delivery carriers[J]. Chinese Journal of New Drugs, 2025 , 34 (17) : 1814 -1819 . DOI: 10.20251/j.cnki.1003-3734.2025.17.004
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doi: 10.20251/j.cnki.1003-3734.2025.17.004
  • Online Date：2026-03-06
  • Published：2025-09-15
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  • Accepted：2025-04-17
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    National Center for Safety evaluation of Drugs, National Institutes for Food and Drug Control, Beijing Key Laboratory of Quality Control and Non-clinical Research and Evaluation for Cellular and Gene Therapy Medicinal Products, Beijing 100176, China
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