Article(id=1321425881898267358, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425847911830056, articleNumber=null, orderNo=null, doi=10.20251/j.cnki.1003-3734.2026.17.004, 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=1757692800000, acceptedDateStr=2025-09-13, onlineDate=1792982081150, onlineDateStr=2026-10-26, pubDate=1789401600000, pubDateStr=2026-09-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792982081150, onlineIssueDateStr=2026-10-26, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792982081150, creator=13701087609, updateTime=1792982081150, updator=13701087609, issue=Issue{id=1321425847911830056, tenantId=1146029695717560320, journalId=1235980733773295621, year='2026', volume='35', issue='17', pageStart='1793', pageEnd='1904', issueExtLink='null', onlineDate='null', pubDate='1789401600000', pubDateStr='2026-09-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1792982073047, creator='13701087609', updateTime=1792982858328, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1321429141673586821, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425847911830056, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1321429141673586822, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425847911830056, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1816, endPage=1821, ext={EN=ArticleExt(id=1321425882091205343, articleId=1321425881898267358, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Progress and safety risk management of registration-based clinical trials of stem cell drugs in China, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective:

This article aims to provide a reference for the dynamic regulatory oversight of clinical trials of stem cell drugs and the enhancement of pharmacovigilance practices.

Methods:

Using data from the Drug Clinical Trial Registration and Information Disclosure Platform and the Pharmacovigilance Database of the Center for Drug Evaluation of the National Medical Products Administration, we conducted a retrospective analysis of the progress of domestic registered clinical trials for stem cell drugs and of individual case safety reports on suspected unexpected serious adverse reactions (SUSAR).

Results:

As of June 30, 2025, a total of 134 Investigational New Drug (IND) applications for stem cell drugs have been approved in China, and 113 registered clinical trials are recorded on the registration platform. From January 2021 to June 2025, a total of 29 domestic SUSAR reports were received, with adverse reactions mainly involving systemic disorders and administration site reactions, as well as respiratory disorders.

Conclusion:

Registered clinical trials of stem cell drugs in China have shown a steady development trend in recent years. Sustained attention must be paid to the long-term potential safety risks of stem cells to safeguard the safety of clinical trials.

, authors=Min LIU, Zhu-xing YAO, Wen-ya TANG, Feng XUE, Hai-xue WANG*, Tao WANG*, authorsList=Min LIU, Zhu-xing YAO, Wen-ya TANG, Feng XUE, Hai-xue WANG, Tao WANG, authorCompany=null, correspAuthors=Hai-xue WANG, Tao WANG, 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=1321425883995419360, articleId=1321425881898267358, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=我国干细胞药物注册临床试验进展与安全风险管理, columnId=1236331159400018080, journalTitle=中国新药杂志, columnName=新药注册与审评技术, runingTitle=null, highlight=null, articleAbstract=
目的:

本文旨在为干细胞药物临床试验的动态监管及提升药物警戒工作水平提供参考。

方法:

基于国家药品监督管理局药品审评中心的药物临床试验登记与信息公示平台与药物警戒数据库,对国内干细胞药物注册临床试验进展和可疑且非预期严重不良反应(suspected unexpected serious adverse reaction, SUSAR)个例安全性报告进行回顾性分析。

结果:

截至2025年6月30日,国内共批准干细胞新药临床试验申请(IND)134项,登记平台有113项注册临床试验。2021年1月—2025年6月,共收到29例境内SUSAR报告,不良反应以全身性疾病及给药部位反应、呼吸相关疾病等为主。

结论:

我国干细胞药物注册临床试验近年来呈现稳步发展态势,持续关注干细胞长期潜在安全风险,为临床试验的安全性保驾护航。

, authors=刘敏, 姚珠星, 唐文雅, 薛峰, 王海学*, 王涛*, authorsList=刘敏, 姚珠星, 唐文雅, 薛峰, 王海学, 王涛, authorCompany=null, correspAuthors=王海学, 王涛, authorNote=

刘敏,女,硕士,主管药师,主要从事临床试验安全风险管理与药物警戒工作。联系电话:(010)80995859,E-mail: 。

, correspAuthorsNote=
* 王海学,男,博士,主任药师,主要从事临床试验安全风险管理与药物警戒工作。联系电话:(010)80995876,E-mail: 。
* 王涛,男,国家药品监督管理局药品审评中心副主任。E-mail: 。
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刘敏,女,硕士,主管药师,主要从事临床试验安全风险管理与药物警戒工作。联系电话:(010)80995859,E-mail: 。

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刘敏,女,硕士,主管药师,主要从事临床试验安全风险管理与药物警戒工作。联系电话:(010)80995859,E-mail: 。

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我国干细胞药物注册临床试验进展与安全风险管理
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刘敏 , 姚珠星 , 唐文雅 , 薛峰 , 王海学 * , 王涛 *
中国新药杂志 | 新药注册与审评技术 2026,35(17): 1816-1821
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中国新药杂志 |新药注册与审评技术 2026 , 35 (17) : 1816 -1821
我国干细胞药物注册临床试验进展与安全风险管理
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刘敏,女,硕士,主管药师,主要从事临床试验安全风险管理与药物警戒工作。联系电话:(010)80995859,E-mail: 。

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刘敏 , 姚珠星, 唐文雅, 薛峰, 王海学* , 王涛*
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:
* 王海学,男,博士,主任药师,主要从事临床试验安全风险管理与药物警戒工作。联系电话:(010)80995876,E-mail: 。
* 王涛,男,国家药品监督管理局药品审评中心副主任。E-mail: 。
作者简介:

刘敏,女,硕士,主管药师,主要从事临床试验安全风险管理与药物警戒工作。联系电话:(010)80995859,E-mail: 。

Progress and safety risk management of registration-based clinical trials of stem cell drugs in China
Min LIU , Zhu-xing YAO, Wen-ya TANG, Feng XUE, Hai-xue WANG* , Tao WANG*
Affiliations
  • Center for Drug Evaluation of the National Medical Products Administration, Beijing 100076, China
出版时间: 2026-09-15 doi: 10.20251/j.cnki.1003-3734.2026.17.004
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目的:

本文旨在为干细胞药物临床试验的动态监管及提升药物警戒工作水平提供参考。

方法:

基于国家药品监督管理局药品审评中心的药物临床试验登记与信息公示平台与药物警戒数据库,对国内干细胞药物注册临床试验进展和可疑且非预期严重不良反应(suspected unexpected serious adverse reaction, SUSAR)个例安全性报告进行回顾性分析。

结果:

截至2025年6月30日,国内共批准干细胞新药临床试验申请(IND)134项,登记平台有113项注册临床试验。2021年1月—2025年6月,共收到29例境内SUSAR报告,不良反应以全身性疾病及给药部位反应、呼吸相关疾病等为主。

结论:

我国干细胞药物注册临床试验近年来呈现稳步发展态势,持续关注干细胞长期潜在安全风险,为临床试验的安全性保驾护航。

干细胞  /  药物注册临床试验  /  可疑且非预期严重不良反应  /  安全风险
Objective:

This article aims to provide a reference for the dynamic regulatory oversight of clinical trials of stem cell drugs and the enhancement of pharmacovigilance practices.

Methods:

Using data from the Drug Clinical Trial Registration and Information Disclosure Platform and the Pharmacovigilance Database of the Center for Drug Evaluation of the National Medical Products Administration, we conducted a retrospective analysis of the progress of domestic registered clinical trials for stem cell drugs and of individual case safety reports on suspected unexpected serious adverse reactions (SUSAR).

Results:

As of June 30, 2025, a total of 134 Investigational New Drug (IND) applications for stem cell drugs have been approved in China, and 113 registered clinical trials are recorded on the registration platform. From January 2021 to June 2025, a total of 29 domestic SUSAR reports were received, with adverse reactions mainly involving systemic disorders and administration site reactions, as well as respiratory disorders.

Conclusion:

Registered clinical trials of stem cell drugs in China have shown a steady development trend in recent years. Sustained attention must be paid to the long-term potential safety risks of stem cells to safeguard the safety of clinical trials.

stem cells  /  drug registration clinical trials  /  suspected unexpected serious adverse reactions  /  safety risk
刘敏, 姚珠星, 唐文雅, 薛峰, 王海学, 王涛. 我国干细胞药物注册临床试验进展与安全风险管理. 中国新药杂志, 2026 , 35 (17) : 1816 -1821 . DOI: 10.20251/j.cnki.1003-3734.2026.17.004
Min LIU, Zhu-xing YAO, Wen-ya TANG, Feng XUE, Hai-xue WANG, Tao WANG. Progress and safety risk management of registration-based clinical trials of stem cell drugs in China[J]. Chinese Journal of New Drugs, 2026 , 35 (17) : 1816 -1821 . DOI: 10.20251/j.cnki.1003-3734.2026.17.004

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doi: 10.20251/j.cnki.1003-3734.2026.17.004
  • 首发时间:2026-10-26
  • 出版时间:2026-09-15
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  • 录用日期:2025-09-13
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    国家药品监督管理局药品审评中心,北京 100076

通讯作者:

* 王海学,男,博士,主任药师,主要从事临床试验安全风险管理与药物警戒工作。联系电话:(010)80995876,E-mail: 。
* 王涛,男,国家药品监督管理局药品审评中心副主任。E-mail: 。
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2种不同金属材料的力学参数
科
Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)
属
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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