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Article(id=1289185809358234404, tenantId=1146029695717560320, journalId=1146031591421210625, issueId=1312073311350256541, articleNumber=null, orderNo=null, doi=10.3981/j.issn.1000-7857.2025.04.00061, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=research-article, receivedDate=1744560000000, receivedDateStr=2025-04-14, revisedDate=1782576000000, revisedDateStr=2026-06-28, acceptedDate=1783267200000, acceptedDateStr=2026-07-06, onlineDate=1785295448865, onlineDateStr=2026-07-29, pubDate=1787846400000, pubDateStr=2026-08-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1790752265552, onlineIssueDateStr=2026-09-30, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=1785295448865, onlineFirstDateStr=2026-07-29, sourceXml=null, magXml=null, createTime=1785295448865, creator=system, updateTime=1785295448865, updator=system, issue=Issue{id=1312073311350256541, tenantId=1146029695717560320, journalId=1146031591421210625, year='2026', volume='44', issue='16', pageStart='1', pageEnd='180', issueExtLink='null', onlineDate='null', pubDate='1787846400000', pubDateStr='2026-08-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1790752254569, creator='13701087609', updateTime=1790753187383, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1312077223981576789, tenantId=1146029695717560320, journalId=1146031591421210625, issueId=1312073311350256541, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1312077223981576790, tenantId=1146029695717560320, journalId=1146031591421210625, issueId=1312073311350256541, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=169, endPage=176, ext={EN=ArticleExt(id=1289185809710555941, articleId=1289185809358234404, tenantId=1146029695717560320, journalId=1146031591421210625, language=EN, title=Progress, challenges, and development recommendations in organoid research and industrial transformation, columnId=1150494643415773491, journalTitle=Science & Technology Review, columnName=Policy Forum, runingTitle=null, highlight=null, articleAbstract=

In recent years, driven by innovation in stem cell theory and technological breakthroughs, relying on the rapid development of engineering technologies such as microfluidics and 3D bioprinting, significant progress has been made in the field of organoid research. The filed of organoid is gradually completing the transformation process from laboratory research to industrialization, penetration into the application markets of biological models, organ transplantation, and biological computing hardware. This paper systematically reviews the global progress in organoid research and development, accurately assessing the current stage of organoid research and industrialization. The study finds that organoid construction has achieved dual breakthroughs in biomimicry and functionality, unlocking new application scenarios, while the industrial system has begun to take shape. On this basis, the study identifies the critical technical bottlenecks and ethical regulatory challenges that urgently need to be addressed in the field of organoid. It further outlines future development directions, including prioritizing new strategies for vascularization and microenvironment simulation, developing novel technologies for in situ monitoring of organoid culture, and formulating supporting ethical regulatory policies and standards. Furthermore, the paper analyzes the current state of organoid development in China from the perspective of three dimensions as the policy support system, the depth of fundamental research, and the competitiveness of industrial chain. Targeted recommendations for high−quality development of organoid in China are then proposed, including: establishing organoid key R&D program, conducting application pilot and demonstrations, improving the standardization system, and designing a tiered governance framework, which aims to provide a reference for leading China toward new heights in the field of organoid.

, authors=Huilin SHI, Chenqi JIN, Ping XU, Yue WANG*, authorsList=Huilin SHI, Chenqi JIN, Ping XU, Yue WANG, authorCompany=null, correspAuthors=Yue WANG, authorNote=null, correspAuthorsNote=null, copyrightStatement=All rights reserved. Unauthorized reproduction is prohibited., 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=1289185810578776874, articleId=1289185809358234404, tenantId=1146029695717560320, journalId=1146031591421210625, language=CN, title=类器官研究与产业转化的进展、挑战与发展建议, columnId=1150494643549991220, journalTitle=科技导报, columnName=政策建议, runingTitle=null, highlight=null, articleAbstract=

近年来，在干细胞理论创新与技术突破的推动下，依托微流控、3D生物打印等工程化技术的快速发展，类器官研究领域取得了显著进展，正逐步完成从实验室研究到产业化的过渡，加速向生物模型、器官移植、生物计算硬件等应用市场渗透。通过系统梳理全球类器官研发进展，精准研判当前类器官研究及产业化所处阶段，研究发现当前类器官构建已实现仿生性与功能性双重突破，解锁应用新场景，产业体系也已初见雏形。在此基础上识别出类器官领域亟待突破的关键技术难题和伦理监管挑战，凝练未来发展方向，包括：重点发展血管化、微环境模拟新策略以及支持类器官培养原位监测的新技术，配套制定伦理监管政策和标准等。进一步结合中国类器官领域发展现状分析，从政策支持体系、基础研究深度、产业链核心环节竞争力3个维度，剖析不足，进而针对性地提出中国类器官高质量发展建议，包括设置类器官重点研发专项、开展应用试点示范、完善标准体系建设以及设计分层治理框架，为引领中国在类器官领域迈向新高地提供参考。

, authors=施慧琳, 靳晨琦, 徐萍, 王玥*, authorsList=施慧琳, 靳晨琦, 徐萍, 王玥, authorCompany=null, correspAuthors=王玥, authorNote=

施慧琳，副研究馆员，研究方向为生命科学战略情报，电子信箱：

, correspAuthorsNote=
王玥（通信作者），副研究馆员，研究方向为生命科学战略情报，电子信箱：
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施慧琳，副研究馆员，研究方向为生命科学战略情报，电子信箱：

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施慧琳，副研究馆员，研究方向为生命科学战略情报，电子信箱：

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类器官应用场景及需求待解决特性问题可能的解决方案
生物模型：高通量、
高时效、可传代和
高仿生		　类器官培养周期长，影响应用进度
　高通量类器官培养存活率、功能一致性
合格率低
　类器官传代次数有限，过程中发生干细胞
耗竭、表观遗传改变、功能退化等问题[29]		　开发基于微流控技术类器官培养策略，通过优化营养供应、模拟生理微环境、精确控制培养条件等方式来解决类器官传代受限的问题[30]
　优化类器官冷冻−复苏方案，使其解冻后能够快速恢复活性，保留主要特征，缩短培养周期[31]
移植器官：大尺寸、
功能成熟且稳定		　现有类器官尺寸多在微米或毫米级别，
难以模拟真实组织、器官
　干细胞残留可能导致畸胎瘤发生
　移植免疫排斥
　类器官与宿主的整合及长期功能维持难[32−33]		　利用生物3D打印、生物材料等开发大尺寸类器官构建技术
　探索增加自杀基因开关可行性
　开发类器官封装技术
计算硬件：
复杂脑模拟		　脑类器官结构简单、规模小，脑回路模拟难，存储和计算能力有限
　脑机接口设备效率低
　脑类器官意识边界存在争议[34]		　厘清脑发育调控关键机制，开发工程化培养策略
　发展新型接口材料、信号解码算法
　制定伦理框架，明确技术红线
), ArticleFig(id=1312073364605338159, tenantId=1146029695717560320, journalId=1146031591421210625, articleId=1289185809358234404, language=CN, label=表1, caption=

不同应用场景下类器官构建、应用特性问题及解决方案

, figureFileSmall=null, figureFileBig=null, tableContent=
类器官应用场景及需求待解决特性问题可能的解决方案
生物模型：高通量、
高时效、可传代和
高仿生		　类器官培养周期长，影响应用进度
　高通量类器官培养存活率、功能一致性
合格率低
　类器官传代次数有限，过程中发生干细胞
耗竭、表观遗传改变、功能退化等问题[29]		　开发基于微流控技术类器官培养策略，通过优化营养供应、模拟生理微环境、精确控制培养条件等方式来解决类器官传代受限的问题[30]
　优化类器官冷冻−复苏方案，使其解冻后能够快速恢复活性，保留主要特征，缩短培养周期[31]
移植器官：大尺寸、
功能成熟且稳定		　现有类器官尺寸多在微米或毫米级别，
难以模拟真实组织、器官
　干细胞残留可能导致畸胎瘤发生
　移植免疫排斥
　类器官与宿主的整合及长期功能维持难[32−33]		　利用生物3D打印、生物材料等开发大尺寸类器官构建技术
　探索增加自杀基因开关可行性
　开发类器官封装技术
计算硬件：
复杂脑模拟		　脑类器官结构简单、规模小，脑回路模拟难，存储和计算能力有限
　脑机接口设备效率低
　脑类器官意识边界存在争议[34]		　厘清脑发育调控关键机制，开发工程化培养策略
　发展新型接口材料、信号解码算法
　制定伦理框架，明确技术红线
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类器官研究与产业转化的进展、挑战与发展建议
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施慧琳 , 靳晨琦 , 徐萍 , 王玥 *
科技导报 | 政策建议 2026,44(16): 169-176
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类器官研究与产业转化的进展、挑战与发展建议
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施慧琳，副研究馆员，研究方向为生命科学战略情报，电子信箱：

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施慧琳，副研究馆员，研究方向为生命科学战略情报，电子信箱：

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施慧琳 , 靳晨琦, 徐萍, 王玥*
作者信息
  • 中国科学院上海营养与健康研究所生命科学信息中心，上海 200031
通讯作者:
王玥（通信作者），副研究馆员，研究方向为生命科学战略情报，电子信箱：
作者简介:

施慧琳，副研究馆员，研究方向为生命科学战略情报，电子信箱：

Progress, challenges, and development recommendations in organoid research and industrial transformation
Huilin SHI , Chenqi JIN, Ping XU, Yue WANG*
Affiliations
  • Shanghai Information Center for Life Sciences, Shanghai Institute of Nutrition and Health, Chinese Academy of Sciences, Shanghai 200031, China
出版时间: 2026-08-28 doi: 10.3981/j.issn.1000-7857.2025.04.00061
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摘要
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近年来，在干细胞理论创新与技术突破的推动下，依托微流控、3D生物打印等工程化技术的快速发展，类器官研究领域取得了显著进展，正逐步完成从实验室研究到产业化的过渡，加速向生物模型、器官移植、生物计算硬件等应用市场渗透。通过系统梳理全球类器官研发进展，精准研判当前类器官研究及产业化所处阶段，研究发现当前类器官构建已实现仿生性与功能性双重突破，解锁应用新场景，产业体系也已初见雏形。在此基础上识别出类器官领域亟待突破的关键技术难题和伦理监管挑战，凝练未来发展方向，包括：重点发展血管化、微环境模拟新策略以及支持类器官培养原位监测的新技术，配套制定伦理监管政策和标准等。进一步结合中国类器官领域发展现状分析，从政策支持体系、基础研究深度、产业链核心环节竞争力3个维度，剖析不足，进而针对性地提出中国类器官高质量发展建议，包括设置类器官重点研发专项、开展应用试点示范、完善标准体系建设以及设计分层治理框架，为引领中国在类器官领域迈向新高地提供参考。

类器官  /  生物模型  /  器官移植  /  生物计算

In recent years, driven by innovation in stem cell theory and technological breakthroughs, relying on the rapid development of engineering technologies such as microfluidics and 3D bioprinting, significant progress has been made in the field of organoid research. The filed of organoid is gradually completing the transformation process from laboratory research to industrialization, penetration into the application markets of biological models, organ transplantation, and biological computing hardware. This paper systematically reviews the global progress in organoid research and development, accurately assessing the current stage of organoid research and industrialization. The study finds that organoid construction has achieved dual breakthroughs in biomimicry and functionality, unlocking new application scenarios, while the industrial system has begun to take shape. On this basis, the study identifies the critical technical bottlenecks and ethical regulatory challenges that urgently need to be addressed in the field of organoid. It further outlines future development directions, including prioritizing new strategies for vascularization and microenvironment simulation, developing novel technologies for in situ monitoring of organoid culture, and formulating supporting ethical regulatory policies and standards. Furthermore, the paper analyzes the current state of organoid development in China from the perspective of three dimensions as the policy support system, the depth of fundamental research, and the competitiveness of industrial chain. Targeted recommendations for high−quality development of organoid in China are then proposed, including: establishing organoid key R&D program, conducting application pilot and demonstrations, improving the standardization system, and designing a tiered governance framework, which aims to provide a reference for leading China toward new heights in the field of organoid.

organoid  /  biological models  /  organ transplantation  /  biological computing
施慧琳, 靳晨琦, 徐萍, 王玥. 类器官研究与产业转化的进展、挑战与发展建议. 科技导报, 2026 , 44 (16) : 169 -176 . DOI: 10.3981/j.issn.1000-7857.2025.04.00061
Huilin SHI, Chenqi JIN, Ping XU, Yue WANG. Progress, challenges, and development recommendations in organoid research and industrial transformation[J]. Science & Technology Review, 2026 , 44 (16) : 169 -176 . DOI: 10.3981/j.issn.1000-7857.2025.04.00061
正文
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类器官是干细胞、前体细胞和/或分化细胞通过细胞−细胞间及细胞−基质间的互作而自发组织形成的体外三维结构，能在多个方面再现体内相应组织或器官的结构与功能[1]。类器官技术的发展始于2009年，荷兰胡布勒支研究所的Hans Clevers团队率先利用成体干细胞，成功构建出首个肠道类器官。此后，类器官技术进入快速发展阶段，在器官重构方面接连取得里程碑式成果，先后入选2013年《Science》十大突破，2017和2023年的《Nature Methods》年度技术。近年来，类器官领域产业发展也已起步，据Market Research Future咨询机构评估，2025年全球类器官市场规模为20.76亿美元，预计到2035年将增长到172.1亿美元，复合年均增长率达23.5%[2]。未来，类器官的器官重构特性将推进其加速渗透至生物模型、移植器官、生物计算硬件等百亿美元级市场，减少无效药物研发投入，打破罕见病等模拟无模型可用的困境，填补器官移植供需缺口，降低生物计算能耗，实现降本增效。
1 全球类器官研究与产业转化进展
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类器官研究旨在充分发挥器官重构功能，致力于突破生物模型仿真瓶颈、重塑再生医学未来、实现生物计算范式革新。在技术进步推动下，已实现从基础构建到应用转化的跨越式发展，产业体系也初具雏形。
1.1 类器官构建实现仿生性与功能性双重突破
随着干细胞、微流控、3D生物打印等前沿技术的进步和融合，研究人员完成了人体内几乎所有的组织或者器官结构功能的简单模拟，且类器官构建仿生性、功能性也获得进一步提升。例如，研究人员已成功构建出多种高度功能化类器官，包括3种关键细胞类型的人类胎儿胰腺类器官[3]，保留上皮细胞、间充质细胞和免疫细胞多样性的十二指肠类器官[4]，具备造血功能的心脏类器官[5]，以及能够模拟血脑屏障功能的脑类器官[6]等。此外，研究还进一步实现了多组织、多器官间的相互作用和连通模拟，构建出肝脏−胆管−胰脏连通类器官[7]、神经−肌肉−骨骼三组织类器官[8]等。
类器官也已快速发展成为生命健康研究的关键工具、生物医药研发的重要利器、未来健康发展的新方向，并开启了生物计算新时代。近年来，类器官作为组织器官模型，被广泛用于模拟器官生长发育、研究宿主−病原体互作[9]、模拟肿瘤异质性[10]等方向。研究人员利用类器官克服罕见病研究无模型可用的困境[11]，揭示了人体发育[12]与衰老[13]过程的机制以及各类传染病[14]、神经系统疾病[15]、代谢系统疾病[16]、癌症等发生发展机制，相关研究为预防生殖缺陷、防范和应对大流行病、直面人口老龄化挑战奠定重要基础。类器官还可作为药物发现和筛选平台以及个性化用药指导工具，助力药物有效性和安全性的快速、精准评估[17]。此外，研究人员也已成功利用类器官培养获得了治疗用种子细胞和替代器官，展现其再生医学应用前景，如在体外生成骨骼肌卫星细胞[18]，制备适合移植的较大的肝脏类器官[19]，并在小鼠实验中证实了其治疗潜力。类器官的另一个令人兴奋的新兴应用方向是生物计算处理器，研究人员正在开发能够执行模式识别和分类等任务的大脑类器官[20]。
1.2 类器官领域发展正从实验室研究向产业化迈进，产业体系已初见雏形
类器官产业体系已初见雏形，产业链上游试剂耗材及设备市场成熟，中游由早期开展类器官研发的研究机构衍生出一批类器官产品研发领军企业，于2013年成功实现技术产业转化，下游各应用方向则处于不同发展阶段（图1）。其中，类器官作为生物模型的药物研发应用推进最快，药企快速涌入。美国通过《2022年食品和药品修正案》，不再将“动物试验”作为药物临床前研发的唯一标准，明确包括类器官的“非临床检测”结果可以作为药物进入临床试验的依据。美国食品药品监督管理局（Food and Drug Administration，FDA）也已批准全球首个完全基于类器官研究获得临床前疗效数据的新药进入临床试验。2025年，FDA更发布声明，计划逐步取消对单克隆抗体等药物安全性研究中的动物试验强制要求，转而推广包括类器官在内的新替代方法。基于类器官的个体化用药指导市场仍在培育阶段，规范化管理是待解决的核心问题。类器官移植应用处于概念验证阶段，目前仅有5项临床研究报道，包括肠类器官治疗溃疡性大肠炎（日本）、视网膜类器官治疗视网膜色素变性（日本）、胰岛移植治疗糖尿病（中国2项）以及唾液腺类器官移植用于恢复放疗后下颌下腺功能（荷兰）[21−22]。生物计算应用则处于技术原型开发阶段，2024年，瑞士Final Spark公司推出首个使用人类神经元进行生物计算的远程研究平台；2025年，澳大利亚Cortical Labs公司发布全球首台商用生物计算机CL1，结合了人类神经元与硅芯片技术，首批CL1已上市，起售价为35000美元。
1.3 未来应用需求牵引下，类器官领域仍面临技术、生产与监管多重挑战
类器官发展整体尚处于技术增长期，当前虽然构建的类器官已经能够一定程度模拟组织器官的结构和功能，但离器官完整重构还有很大距离。例如，类器官构建结构和功能完整度、成熟度有限，缺少生态位特异性间充质细胞、免疫细胞、血管化、神经支配或微生物组；无法形成如器官般的精细结构和特殊结构，如肠的官腔状结构等；仅能代表胎儿表型，并非完全成熟状态[23]。与此同时，类器官培养仍存在异质性，基质胶成分的复杂性、标准化培养方法缺失和依赖于人工操作等因素致使类器官培养可控性和可重复性差，距离规模化生产仍有较大差距。另外，受限于检测技术，一些类器官关键生物学特性和功能可能难以实时定量测量，质量评估难度大[24]。面向上述核心挑战，可以看到，现阶段类器官技术突破的重点是发展基因编辑、共培养、微流控芯片、3D生物打印技术，开发血管化、微环境模拟新策略；利用新生物材料，结合工程化设计，打造标准化、自动化培养和生产方案[25−26]；集成微传感器、空间多重原位分析技术、长时程实时活细胞成像技术等，实现类器官培养原位监测[27]。在技术瓶颈和生产壁垒之外，由于类器官及其应用涉及医用和产品开发，伦理监管政策和标准配套亟待加强，包括类器官道德地位、数据隐私考量[28]，分级合规监管责任主体的确认以及相应国际质量标准建立等。
除了上述共性问题，面向不同应用场景及需求，还需要解决系列特性问题，跨越相关技术和监管鸿沟，推进类器官应用场景的全面落地（表1）。
2 中国类器官研究与产业转化发展现状及问题
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2.1 中国类器官领域政府支持资金分散，且长期、系统投入不足
类器官研究需要跨学科和高成本投入，国际上技术领先国家/地区通过政府专项基金和企业资本提供持续支持。美国2011年将器官芯片研究上升为国家战略层面进行重点支持，美国国立卫生研究院、国防部高级研究计划局以及FDA合作，设置专项计划，分阶段持续推进从器官芯片构建到疾病模型建立再到药物研发和精准医疗应用[35]。2024年，面向基于类器官智能的生物计算这一新前沿方向，美国国家科学基金会启动专项计划，资助1400万美元支持相关跨学科研究[36]。国际制药龙头企业罗氏已出资成立人类生物学研究所，专注于类器官等人类模型系统领域的研究。
中国对类器官的支持集中于“十三五”之后，已通过国家重点研发计划“干细胞及转化研究”和“干细胞研究与器官修复”重点专项、国家自然科学基金项目资助了类器官相关研究，但总体来看，资金分散且偏向短期项目，缺乏对类器官基础研究的长期、系统支持，例如，2023年国家自然科学基金支持了76个类器官相关项目，总金额为3355万元，单个项目仅数十万至百万级。
2.2 中国类器官基础研究和应用突破不断，但部分方向仍存在研究短板
中国类器官研究起步晚，但发展迅速，仅次于美国、荷兰等技术领先和技术发起国家。研发优势力量集中在北京、长三角、广东、川渝、大连等城市和地区，已在胰岛、肝脏、骨类器官构建、结合微流控技术的类器官芯片开发方面取得重大进展。例如，研究人员在率先鉴定获得胰岛成体干细胞的基础上，建立了胰岛类器官长期扩增培养体系[37]；开展临床前研究，证实了微囊化可增殖人肝细胞类器官肝衰竭治疗潜力[38]；成功构建了能够体内外长时间培养、多细胞分化、自矿化的大尺寸骨类器官[39]；攻关微流控核心技术，利用类器官芯片成功模拟肝脏−胰岛互作[40]。但需要注意的是，在部分方向，中国仍存在研究短板，核心竞争力待进一步加强，例如，肿瘤类器官研究论文多，但开创性的研究工作较少，多聚焦于应用层面（如药物敏感性测试），对自组织理论、基于多器官耦合的肿瘤转移微环境模拟等方向探索少；特定组织类器官如肾脏等泌尿系统类器官研究布局少，进展相对较慢。可以看到，中国发表的肾脏类器官论文数量占全球比例为12.29%，明显低于类器官整体水平21.77%。
2.3 中国类器官产业发展亟待强链补链，关键环节核心竞争力弱
2.3.1 产业链上游部分高端试剂耗材依赖于国外
中国类器官产业链上游部分高端试剂耗材依赖于国外（图2）。其中，类器官培养原材料生产部分存在较高技术壁垒，国产替代推进难，如类器官构建成本中占比较高的基质胶市场长期被美国康宁、赛默飞、R&D Systems等国际品牌占据，3大厂商市场总份额占比达73%，中国虽然已有企业推出国产产品，但面临产品质量不稳定、核心技术缺失、品牌知名度较低的困境，短期内难以实现国产替代。高精度耗材如微流控芯片加工难度大，国产产品良率低。另外，在3D生物打印设备、类器官自动化平台设备开发方向，中国整体处于跟随状态，致力于技术开发和完善，需进一步攻克部分技术难点，加速相关设备在类器官培养中的落地应用。
2.3.2 产业链中游企业核心竞争力不足
中国类器官研发企业的成立时间集中在2016年之后，相较于国际龙头企业起步较晚，但正在通过技术创新加速追赶。例如美国Emulate、Hesperos和德国TissUse GmbH等企业已率先完成多器官人体芯片模型商业化开发，对标这些巨头，大橡科技、艾玮得生物、溥思生物公司加速推进微流控工艺攻关，实现多器官集成的类器官芯片开发。另外，与英国Cellesce公司专注于类器官开发、放大和制造的商业化路径相似，丹望医疗等企业正在着力发展自动化、标准化类器官生产体系。同时，多家企业也正在进行特色技术创新攻关，例如礼升生物公司建立了无需基质胶的类器官培养体系，实现了类器官的血管化和免疫化，显著提高了类器官的培养成功率，并降低了成本和缩短了时间；朴衡科技公司推出基于核酸材料的体外3D器官培养技术，加强类器官培养的可控性。不过，从企业规模和技术竞争力来看，中国相关企业相较国际上技术领先企业仍有较为明显的差距，以技术服务为主，缺少像荷兰HUB Organoids公司这类在类器官培养方法、基因编辑工具、疾病模型构建等方向布局大量核心专利，掌握底层技术，通过技术授权、设备销售获取高附加值收益，主导全球市场的企业。
另外，在类器官样本库建设方面，中国企业目前是以规模大和数量多为目标导向，质量参差不齐，且这些企业主要通过提供药物敏感性检测获取肿瘤样本，构建肿瘤类器官，正常组织类器官存储量很有限，亟待改进。例如荷兰HUB Organoids公司的生物样本库中包含健康人群，癌症、遗传病患者的肠、肺、头部、颈部、肝脏、卵巢类器官，而中国大橡科技、丹望医疗、华医再生、普罗布诺、科途医学等企业虽然也已建立类器官生物样本库，但样本类型以高发肿瘤类器官为主。
2.3.3 产业链下游应用有望实现弯道超车
中国正在推进产业链下游类器官应用发展，在部分方向跻身全球前列，例如基于类器官的器官移植应用，目前已报道了5项临床研究，其中2项为中国科学家主导的胰岛移植治疗糖尿病。但可以看到，受限于技术成熟度低、标准和监管政策缺失，部分应用方向在中国推广受限，例如相较于美国FDA已批准完全基于类器官研究获得临床前疗效数据的新药进入临床试验，中国关于类器官研发企业和药企之间的合作尚停留在将类器官研究数据作为常规动物模型研究的补充信息，支持新药临床试验申请。在类器官智能开发方向，也尚未见国内企业布局基于类器官的生物计算机产品开发的报道。
2.4 中国类器官领域监管政策层级低，应用适配度差，行业规范发展受阻
类器官技术复杂程度高、应用场景丰富，但目前中国相关监管政策主要停留在协会、科学家团体等出台的标准、专家共识或是国家药品监督管理局发布的技术指导原则层面，且基本围绕特定组织类器官制备、鉴定展开，未充分考虑不同应用场景需求，将影响类器官行业标准化、规范化发展。例如由于没有相关规范约束，当前类器官药物敏感性检测服务，医院仅提供临床应用场景，由类器官企业直接与病患订立检测合约并结算，其中部分企业未取得第三方实验室资质，存在较大合规风险。
3 中国类器官发展建议
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3.1 面向类器官未来应用需求，设置类器官重点专项，加速成果产业转化应用
面向类器官未来应用需求，建议在“十五五”阶段，设置类器官重点专项，组建多学科交叉、产学研联合团队，支持类器官基础研究和平台标准建设，攻克类器官构建及应用中技术瓶颈和生产壁垒。其中，建议借鉴美国国防部高级研究计划局项目经理制管理模式，以应用为导向，确定技术挑战，制定分阶段目标，完成技术决策，进行全链条布局、全过程管理和全生命周期培育。
3.2 率先在北京、广东、长三角地区培育产业生态，开展应用试点示范
北京、广东和长三角地区生物医药企业集聚，临床研究优势显著，是类器官下游应用重要“试验田”，且国内已有的类器官研发企业有85%以上来自这些地区，是类器官技术开发的关键“创新田”，为类器官产业发展奠定重要基础。建议率先在上述地区，加大投资力度，打造类器官产业集群和全生命周期技术平台，打通上游试剂耗材、中游产品研发、下游多方向应用全链条。与此同时，支持在上述地区开展类器官应用试点示范，构建完整的类器官产业生态链，例如加速完全基于类器官研究获得临床前数据的新药进入临床试验，在合规条件下推进类器官药物敏感性测试实验室自建检测（laboratory developed test，LDT）项目进入临床。
3.3 完善类器官资源库和标准体系配套建设，推进类器官行业的标准化发展
采用干湿库相结合的策略，联合研究院所、医院、企业优势力量，基于标准化操作流程，建设高质量类器官样本库，覆盖人源正常组织和疾病组织，同时整合临床信息、组学信息、应用信息等，配套建设完整的生物信息数据库。推动专家共识、团体标准升级，在类器官制备、鉴定等概念性标准基础上，针对特定使用场景，探索并建立用户信任、监管方可参考的类器官质量评价指标及质量控制标准。例如，在类器官应用推进最快的药物研发方向，加快推进类器官替代动物试验的可行性系统验证，同步构建类器官试验的标准规范与指南体系。通过试验明确类器官在药物毒性评估、疗效评价等场景替代动物试验的适用范围与边界，同时细化试验流程、质量控制指标及结果解读准则，为类器官技术规模化应用于药物研发提供科学依据与操作框架，抢占技术应用与规则制定的先机。
3.4 深入研究类器官相关伦理和监管问题，分层设计类器官治理框架
鉴于人源类器官研究的特殊性、复杂性和敏感性，不同类型类器官、不同应用场景面临伦理问题和需要配套监管政策不同，建议设计针对性治理框架。首先，加强类器官技术的伦理审查，制定差异化的伦理审查标准，限制部分具有高道德地位的类器官的商业化。同时，探索更加合理的知情同意模式，例如参考“同意治理”模式，综合考虑未来使用的情境，开展持续治理。其次，确定类器官技术应用的监管主体，建议由国家卫生健康委员会负责类器官药物敏感性检测临床研究的监管，由国家药品监督管理局负责类器官在新药研发方面的应用管理，以及类器官作为产品，例如诊断器械、细胞治疗产品的上市审批。最后，面向不同应用场景，制定特色的类器官研发和生产全流程监管规范，以确保类器官的质量和安全性。
基金
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  • 上海市科委2024年度“科技创新行动计划”软科学研究项目(24692102700)
  • 上海市科委2025年度“科技创新行动计划”软科学项目(25692119603)
  • 中国科协战略发展部2024年度科技智库青年人才计划(XMSB20240711014)
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2026年第44卷第16期
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doi: 10.3981/j.issn.1000-7857.2025.04.00061
  • 接收时间：2025-04-14
  • 首发时间：2026-07-29
  • 出版时间：2026-08-28
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  • 收稿日期：2025-04-14
  • 修回日期：2026-06-28
  • 录用日期：2026-07-06
基金
上海市科委2024年度“科技创新行动计划”软科学研究项目(24692102700)
上海市科委2025年度“科技创新行动计划”软科学项目(25692119603)
中国科协战略发展部2024年度科技智库青年人才计划(XMSB20240711014)
作者信息
    中国科学院上海营养与健康研究所生命科学信息中心，上海 200031

通讯作者:

王玥（通信作者），副研究馆员，研究方向为生命科学战略情报，电子信箱：
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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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