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Article(id=1292135551935730295, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135425250976333, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.10.021, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1775836800000, receivedDateStr=2026-04-11, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785998722298, onlineDateStr=2026-08-06, pubDate=1779897600000, pubDateStr=2026-05-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785998722298, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785998722298, creator=13701087609, updateTime=1785998722298, updator=13701087609, issue=Issue{id=1292135425250976333, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='10', pageStart='1351', pageEnd='1500', issueExtLink='null', onlineDate='null', pubDate='1779897600000', pubDateStr='2026-05-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785998692095, creator='13701087609', updateTime=1786014373634, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292201198489202995, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135425250976333, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292201198489202996, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135425250976333, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1479, endPage=1484, ext={EN=ArticleExt(id=1292135552288051832, articleId=1292135551935730295, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Analysis on the current situation of clinical trials of inhaled preparations in China based on registration data, columnId=1292126496848638045, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Regulatory Science Column, runingTitle=null, highlight=null, articleAbstract=
Objective

To analyze the current status and development trends of registered clinical trials of inhalation preparations in China, and to provide references for drug development and clinical evaluation.

Methods

Clinical trials of inhalation preparations registered on the NMPA Platform for Drug Clinical Trial Registration and Information Publicity from its inception to December 31, 2025 were retrieved. Descriptive statistical analysis was conducted on the basic information, design types, drug characteristics, and indications of the trials.

Results

A total of 445 registered clinical trials of inhalation preparations were included, which had entered a rapid development phase in the past five years. The trials were predominantly domestic (94.61%) and bioequivalence (BE) studies (48.31%). The most common dosage forms were liquid inhalation formulations (44.04%) and dry powder inhalations (35.51%). Research and development were highly concentrated on asthma and chronic obstructive pulmonary disease, with inhaled corticosteroids and their combinations being the main directions. In contrast, trials involving childer and adolescents accounted for only 4.94%, and explorations in areas such as pulmonary fibrosis and pulmonary infections remained relatively limited. Sponsors and research resources were primarily concentrated in the more developed pharmaceutical regions such as Beijing, Shanghai, and Jiangsu.

Conclusion

The development of inhalation preparations in China has entered a phase of rapid growth, characterized by a dominance of generic drugs, a high concentration of therapeutic areas, and differentiated development of dosage forms. Future efforts should focus on unmet clinical needs and innovative research and development of high-technical-barrier dosage forms to promote high-quality development in this field.

, authors=Zhen-wei XIE1, Fei TANG2, Miao WANG3, Yu-fei FENG1, Zhao-long CAO4, authorsList=Zhen-wei XIE, Fei TANG, Miao WANG, Yu-fei FENG, Zhao-long CAO, authorCompany=null, correspAuthors=Zhao-long CAO, 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=1292135552501961337, articleId=1292135551935730295, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=基于登记数据的我国吸入制剂临床试验现状分析, columnId=1292126497112879199, journalTitle=中国临床药理学杂志, columnName=药物监管科学专栏, runingTitle=null, highlight=null, articleAbstract=
目的

分析我国吸入制剂注册临床试验的现状，为药物研发与临床评价提供参考。

方法

检索国家药品监督管理局药物临床试验登记与信息公示平台自建库至2025年12月31日登记的吸入制剂临床试验，对试验基本信息、设计类型、药物特征及适应症等进行描述性统计分析。

结果

共纳入445项吸入制剂临床试验，近5年进入快速发展期。试验以国内试验（94.61%）和生物等效性（BE）研究（48.31%）为主；剂型以吸入液体制剂（44.04%）和吸入粉雾剂（35.51%）居多。研发领域集中在哮喘与慢性阻塞性肺疾病，按照药理作分类吸入糖皮质激素及其复方制剂是主要研发方向。青少年和/或儿童试验仅占4.94%，针对肺纤维化、肺部感染等领域的探索亦相对有限。申办方与研究中心主要集中于北京、上海和江苏等医药发达地区。

结论

我国吸入制剂研发已进入高速发展期，呈现以仿制药为主导、治疗领域高度集中、吸入制剂型研发差异化的特点。未来应关注未满足需求及具有高技术壁垒剂型的创新研发。

, authors=谢振伟1, 唐飞2, 王淼3, 封宇飞1, 曹照龙4, authorsList=谢振伟, 唐飞, 王淼, 封宇飞, 曹照龙, authorCompany=null, correspAuthors=曹照龙, authorNote=

谢振伟（1989－），男，管理助理研究员，主要从事临床试验管理相关工作和研究

, correspAuthorsNote=
曹照龙，主任医师 Tel: （010）88325259 E-mail:
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谢振伟（1989－），男，管理助理研究员，主要从事临床试验管理相关工作和研究

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谢振伟（1989－），男，管理助理研究员，主要从事临床试验管理相关工作和研究

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基于登记数据的我国吸入制剂临床试验现状分析
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谢振伟 1 , 唐飞 2 , 王淼 3 , 封宇飞 1 , 曹照龙 4
中国临床药理学杂志 | 药物监管科学专栏 2026,42(10): 1479-1484
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中国临床药理学杂志 |药物监管科学专栏 2026 , 42 (10) : 1479 -1484
基于登记数据的我国吸入制剂临床试验现状分析
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谢振伟1, 唐飞2, 王淼3, 封宇飞1, 曹照龙4
作者信息
  • 1.北京大学人民医院 临床试验机构，北京 100044
  • 2.北京大学人民医院 呼吸与危重医学科，北京 100044
  • 3.北京海金格医药科技股份有限公司，北京 100161
  • 4.北京大学人民医院 全科医学科，北京 100044
通讯作者:
曹照龙，主任医师 Tel: （010）88325259 E-mail:
作者简介:

谢振伟（1989－），男，管理助理研究员，主要从事临床试验管理相关工作和研究

Analysis on the current situation of clinical trials of inhaled preparations in China based on registration data
Zhen-wei XIE1, Fei TANG2, Miao WANG3, Yu-fei FENG1, Zhao-long CAO4
Affiliations
  • 1.Clinical Trial Institution, Peking University People’s Hospital, Beijing 100044, China
  • 2.Department of Respiratory and Critical Care Medicine, Peking University People’s Hospital, Beijing 100044, China
  • 3.Beijing Haijinge Pharmaceutical Technology Co., Ltd., Beijing 100161, China
  • 4.Department of General Practice, Peking University People’s Hospital, Beijing 100044, China
出版时间: 2026-05-28 doi: 10.13699/j.cnki.1001-6821.2026.10.021
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摘要
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目的

分析我国吸入制剂注册临床试验的现状，为药物研发与临床评价提供参考。

方法

检索国家药品监督管理局药物临床试验登记与信息公示平台自建库至2025年12月31日登记的吸入制剂临床试验，对试验基本信息、设计类型、药物特征及适应症等进行描述性统计分析。

结果

共纳入445项吸入制剂临床试验，近5年进入快速发展期。试验以国内试验（94.61%）和生物等效性（BE）研究（48.31%）为主；剂型以吸入液体制剂（44.04%）和吸入粉雾剂（35.51%）居多。研发领域集中在哮喘与慢性阻塞性肺疾病，按照药理作分类吸入糖皮质激素及其复方制剂是主要研发方向。青少年和/或儿童试验仅占4.94%，针对肺纤维化、肺部感染等领域的探索亦相对有限。申办方与研究中心主要集中于北京、上海和江苏等医药发达地区。

结论

我国吸入制剂研发已进入高速发展期，呈现以仿制药为主导、治疗领域高度集中、吸入制剂型研发差异化的特点。未来应关注未满足需求及具有高技术壁垒剂型的创新研发。

吸入制剂  /  临床试验  /  哮喘  /  慢性阻塞性肺疾病
Objective

To analyze the current status and development trends of registered clinical trials of inhalation preparations in China, and to provide references for drug development and clinical evaluation.

Methods

Clinical trials of inhalation preparations registered on the NMPA Platform for Drug Clinical Trial Registration and Information Publicity from its inception to December 31, 2025 were retrieved. Descriptive statistical analysis was conducted on the basic information, design types, drug characteristics, and indications of the trials.

Results

A total of 445 registered clinical trials of inhalation preparations were included, which had entered a rapid development phase in the past five years. The trials were predominantly domestic (94.61%) and bioequivalence (BE) studies (48.31%). The most common dosage forms were liquid inhalation formulations (44.04%) and dry powder inhalations (35.51%). Research and development were highly concentrated on asthma and chronic obstructive pulmonary disease, with inhaled corticosteroids and their combinations being the main directions. In contrast, trials involving childer and adolescents accounted for only 4.94%, and explorations in areas such as pulmonary fibrosis and pulmonary infections remained relatively limited. Sponsors and research resources were primarily concentrated in the more developed pharmaceutical regions such as Beijing, Shanghai, and Jiangsu.

Conclusion

The development of inhalation preparations in China has entered a phase of rapid growth, characterized by a dominance of generic drugs, a high concentration of therapeutic areas, and differentiated development of dosage forms. Future efforts should focus on unmet clinical needs and innovative research and development of high-technical-barrier dosage forms to promote high-quality development in this field.

inhalation preparations  /  clinical trials  /  asthma  /  chronic obstructive pulmonary disease
谢振伟, 唐飞, 王淼, 封宇飞, 曹照龙. 基于登记数据的我国吸入制剂临床试验现状分析. 中国临床药理学杂志, 2026 , 42 (10) : 1479 -1484 . DOI: 10.13699/j.cnki.1001-6821.2026.10.021
Zhen-wei XIE, Fei TANG, Miao WANG, Yu-fei FENG, Zhao-long CAO. Analysis on the current situation of clinical trials of inhaled preparations in China based on registration data[J]. Chinese Journal of Clinical Pharmacology, 2026 , 42 (10) : 1479 -1484 . DOI: 10.13699/j.cnki.1001-6821.2026.10.021
基金
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  • 北京国际医药临床研发平台（CRO平台）项目(2107000043)
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2026年第42卷第10期
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doi: 10.13699/j.cnki.1001-6821.2026.10.021
  • 接收时间：2026-04-11
  • 首发时间：2026-08-06
  • 出版时间：2026-05-28
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  • 收稿日期：2026-04-11
基金
北京国际医药临床研发平台（CRO平台）项目(2107000043)
作者信息
    1.北京大学人民医院 临床试验机构，北京 100044
    2.北京大学人民医院 呼吸与危重医学科，北京 100044
    3.北京海金格医药科技股份有限公司，北京 100161
    4.北京大学人民医院 全科医学科，北京 100044

通讯作者:

曹照龙，主任医师 Tel: （010）88325259 E-mail:
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https://castjournals.cast.org.cn/joweb/zglcylxzz/CN/10.13699/j.cnki.1001-6821.2026.10.021
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2种不同金属材料的力学参数
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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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