预防用自扩增mRNA疫苗药学研究的考虑  

Considerations for pharmaceutical studies of prophylactic self-amplifying RNA vaccines

作　　者：杨丹 赵欣 胡琳 张东 李敏 YANG Dan;ZHAO Xin;HU Lin;ZHANG Dong;LI Min(Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China;Yangtze River Delta Branch Center for Drug Evaluation and Inspection of The National Medicine Products Administration,Shanghai 201210,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100076 [2]国家药品监督管理局药品审评检查长三角分中心,上海201210

出　　处：《中国新药杂志》2025年第1期52-56,共5页Chinese Journal of New Drugs

摘　　要：自扩增mRNA(self-amplifying, saRNA)从概念提出至今已经历了30年左右的发展,但由于其在药学和药效学研究等方面具有一定的复杂性,整体上其研发速度略滞后于非扩增mRNA。本文基于对saRNA疫苗研究进展及作用机制的介绍,进一步探讨其开发过程中结合产品工艺特点及产品特点的关注点,以期为预防用saRNA疫苗的药学研究提供参考。Nearly thirty years have passed since the concept of self-amplifying RNA(saRNA)was first introduced.However,the overall development of saRNA technology has slightly lagged behind conventional mRNA due to its complexity in pharmaceutical and pharmacological studies.This paper reviews the research progress and the mechanisms of action of saRNA vaccines,and further discusses the challenges in vaccine development.We consider both the intrinsic characteristics of saRNA and the manufacturing processes involved,aiming to provide a reference for the pharmaceutical research of prophylactic saRNA vaccines.

关 键 词：自扩增mRNA 双链RNA 固有免疫应答 质量研究 

分 类 号：R95[医药卫生—药学]