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As a representative of the new generation of nucleic acid vaccine technology, messenger ribonucleic acid (mRNA) vaccines have demonstrated advantages such as rapid manufacture, high efficacy, and good safety since Coronavirus Disease 2019(COVID-19), becoming an important direction in global vaccine research and development. Many mRNA vaccines have been approved or in clinical trials. This article systematically reviews and summarizes the current research and development of mRNA vaccines, discussing the current state of mRNA vaccine development and evaluation strategies in China, with the aim of providing scientific basis for the development of mRNA vaccines.

, authors=Xia DENG, Shuang LU, authorsList=Xia DENG, Shuang LU, authorCompany=null, correspAuthors=Shuang LU, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1291707201236788128, articleId=1291707200276292510, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=国内外mRNA疫苗临床研发进展和审评考虑, columnId=1291339025730760957, journalTitle=中国临床药理学杂志, columnName=药物评价与管理, runingTitle=null, highlight=null, articleAbstract=

信使核糖核酸(mRNA)疫苗作为新一代核酸疫苗技术的代表,自新型冠状病毒肺炎疫情以来展现出快速研发、高效保护和良好安全性等优势,成为全球疫苗研发的重要方向。全球已有多款mRNA疫苗获批上市或进入临床试验。本文系统梳理并总结了当前国内外mRNA疫苗的研发进展,讨论了我国mRNA疫苗的研发现状及审评策略,以期为mRNA疫苗的研发提供科学依据。

, authors=邓霞, 鲁爽, authorsList=邓霞, 鲁爽, authorCompany=null, correspAuthors=鲁爽, authorNote=

邓霞(1987-),女,副研究员,主要从事疫苗临床专业审评相关工作

, correspAuthorsNote=
鲁爽,研究员 Tel: (010)80995678 E-mail:
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邓霞(1987-),女,副研究员,主要从事疫苗临床专业审评相关工作

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国内外mRNA疫苗临床研发进展和审评考虑
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邓霞 , 鲁爽
中国临床药理学杂志 | 药物评价与管理 2025,41(22): 3290-3295
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中国临床药理学杂志 |药物评价与管理 2025 , 41 (22) : 3290 -3295
国内外mRNA疫苗临床研发进展和审评考虑
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邓霞, 鲁爽
作者信息
  • 国家药品监督管理局 药品审评中心,北京,100076
通讯作者:
鲁爽,研究员 Tel: (010)80995678 E-mail:
作者简介:

邓霞(1987-),女,副研究员,主要从事疫苗临床专业审评相关工作

Progress in clinical research and review considerations of mRNA vaccines in China and abroad
Xia DENG, Shuang LU
Affiliations
  • Center for Drug Evaluation, National Medical Products Administration, Beijing 100076, China
出版时间: 2025-11-28 doi: 10.13699/j.cnki.1001-6821.2025.22.021
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信使核糖核酸(mRNA)疫苗作为新一代核酸疫苗技术的代表,自新型冠状病毒肺炎疫情以来展现出快速研发、高效保护和良好安全性等优势,成为全球疫苗研发的重要方向。全球已有多款mRNA疫苗获批上市或进入临床试验。本文系统梳理并总结了当前国内外mRNA疫苗的研发进展,讨论了我国mRNA疫苗的研发现状及审评策略,以期为mRNA疫苗的研发提供科学依据。

mRNA疫苗  /  临床试验  /  审评考虑

As a representative of the new generation of nucleic acid vaccine technology, messenger ribonucleic acid (mRNA) vaccines have demonstrated advantages such as rapid manufacture, high efficacy, and good safety since Coronavirus Disease 2019(COVID-19), becoming an important direction in global vaccine research and development. Many mRNA vaccines have been approved or in clinical trials. This article systematically reviews and summarizes the current research and development of mRNA vaccines, discussing the current state of mRNA vaccine development and evaluation strategies in China, with the aim of providing scientific basis for the development of mRNA vaccines.

mRNA vaccines  /  clinical trial  /  review considerations
邓霞, 鲁爽. 国内外mRNA疫苗临床研发进展和审评考虑. 中国临床药理学杂志, 2025 , 41 (22) : 3290 -3295 . DOI: 10.13699/j.cnki.1001-6821.2025.22.021
Xia DENG, Shuang LU. Progress in clinical research and review considerations of mRNA vaccines in China and abroad[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (22) : 3290 -3295 . DOI: 10.13699/j.cnki.1001-6821.2025.22.021
  • 药品监管科学全国重点实验室基金资助项目(2024SKLDRS0229)
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doi: 10.13699/j.cnki.1001-6821.2025.22.021
  • 接收时间:2025-09-29
  • 首发时间:2026-08-05
  • 出版时间:2025-11-28
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  • 收稿日期:2025-09-29
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药品监管科学全国重点实验室基金资助项目(2024SKLDRS0229)
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    国家药品监督管理局 药品审评中心,北京,100076

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鲁爽,研究员 Tel: (010)80995678 E-mail:
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2种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
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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