Article(id=1321425909354184989, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425881147495164, articleNumber=null, orderNo=null, doi=10.20251/j.cnki.1003-3734.2026.18.004, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1761753600000, acceptedDateStr=2025-10-30, onlineDate=1792982087695, onlineDateStr=2026-10-26, pubDate=1790697600000, pubDateStr=2026-09-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792982087695, onlineIssueDateStr=2026-10-26, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792982087695, creator=13701087609, updateTime=1792982087695, updator=13701087609, issue=Issue{id=1321425881147495164, tenantId=1146029695717560320, journalId=1235980733773295621, year='2026', volume='35', issue='18', pageStart='1905', pageEnd='2016', issueExtLink='null', onlineDate='null', pubDate='1790697600000', pubDateStr='2026-09-30', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1792982080970, creator='13701087609', updateTime=1792982834300, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1321429040930599029, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425881147495164, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1321429040930599030, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425881147495164, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1932, endPage=1938, ext={EN=ArticleExt(id=1321425910851551518, articleId=1321425909354184989, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Key points for nonclinical safety evaluation of mRNA vaccines, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

mRNA therapeutics have emerged as a promising platform in treating a wide range of diseases, including cancers, infections, genetic disorders, and autoimmune diseases. This article reviews the current development status of mRNA vaccines, existing challenges, relevant guidelines for nonclinical evaluation, and key focuses of nonclinical safety evaluation. Nonclinical research should focus on proof of concept, administration routes, species selection, and toxicity characteristics (such as inflammatory responses, hepatosplenic toxicity, and immune responses). This article systematically summarizes the research progress and safety evaluation strategies of mRNA vaccines, providing important references for future studies.

, authors=Ming-lan ZHENG, Xiao-fen LI, Zi-wei LI, Meng-ran ZHANG, Hui-fang YIN, Yi FAN^*, authorsList=Ming-lan ZHENG, Xiao-fen LI, Zi-wei LI, Meng-ran ZHANG, Hui-fang YIN, Yi FAN, authorCompany=null, correspAuthors=Yi FAN, 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=1321425911245816095, articleId=1321425909354184989, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=mRNA疫苗非临床安全性评价的关注点, columnId=1236331159400018080, journalTitle=中国新药杂志, columnName=新药注册与审评技术, runingTitle=null, highlight=null, articleAbstract=

mRNA疫苗已经成为治疗多种疾病的最有前景的平台，包括传染病、癌症、遗传性疾病和自身免疫性疾病。本文重点综述了mRNA疫苗发展现状、存在的挑战、非临床评价相关指导原则、非临床安全性评价的关注点，重点探讨非临床研究需关注概念验证、给药途径、种属选择和毒性特点（如炎症反应、肝脾毒性和免疫反应），以期为未来研究提供重要参考。

, authors=郑明岚, 李小芬, 李紫薇, 张梦然, 尹慧芳, 范乙^*, authorsList=郑明岚, 李小芬, 李紫薇, 张梦然, 尹慧芳, 范乙, authorCompany=null, correspAuthors=范乙, authorNote=, correspAuthorsNote=, copyrightStatement=null, copyrightOwner=《中国新药杂志》有限公司, extLink=null, articleAbsUrl=null, sourceXml=QqadKh3A2/OUat2299zirg==, magXml=l9+la2l1MQIBE95RikgoRw==, pdfUrl=null, pdf=QpsW7F5HgEwXb4PhDjviLw==, pdfFileSize=1509845, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=VG5NyPqOlWu3ytIQ7Dynhw==, mapNumber=null, fund=null)}, authors=[Author(id=1321425911535223076, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425909354184989, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=zhengml@ydcdei.org.cn, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1321425911614914854, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425909354184989, authorId=1321425911535223076, language=EN, stringName=Ming-lan ZHENG, firstName=Ming-lan, middleName=null, lastName=ZHENG, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Yangtze River Delta Center for Drug Evaluation and Inspection of National Medical Products Administration, Shanghai 201210, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1321425911682023719, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425909354184989, authorId=1321425911535223076, language=CN, stringName=郑明岚, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=国家药品监督管理局药品审评检查长三角分中心，上海 201210, bio={"content":"

郑明岚，女，副研究员，研究方向：新药药理毒理审评。E-mail: zhengml@ydcdei.org.cn。

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郑明岚，女，副研究员，研究方向：新药药理毒理审评。E-mail: zhengml@ydcdei.org.cn。

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