间充质干细胞基础研究与临床转化的中美比较

doi:10.13523/j.cb.1909020

中国生物工程杂志

2020, Vol. 40

Issue (4): 97-107 DOI: 10.13523/j.cb.1909020

行业分析

间充质干细胞基础研究与临床转化的中美比较

苑亚坤^1,²,刘广洋^3,⁴,刘拥军^3,⁴,谢亚芳^3,⁴,吴昊^1,^2,^*(

)

1 中国科学院文献情报中心北京 100190
2 中国科学院大学经济与管理学院北京 100190
3 北京亦创生物技术产业研究院干细胞与再生医学研究所北京 100176
4 北京贝来生物科技有限公司北京 100176

Comparison of Research and Clinical Transformation on Mesenchymal Stem Cells between China and the US

YUAN Ya-kun^1,²,LIU Guang-yang^3,⁴,LIU Yong-jun^3,⁴,XIE Ya-fang^3,⁴,WU Hao^1,^2,^*(

)

1 National Science Library, Chinese Academy of Sciences, Beijing 100190, China
2 School of Economics and Management, University of Chinese Academy of Sciences, Beijing 100190, China
3 Stem Cell Biology and Regenerative Medicine Institution, Yi-Chuang Institute of Bio- Industry, Beijing 100176, China
4 Beijing Believe China Biotech Co., Ltd. Beijing 100176, China

全文: PDF(1421 KB) HTML

摘要：

目的：从基础研究、专利申请、临床试验角度对比分析中美间充质干细胞领域发展现状和趋势,了解中美间充质干细胞领域研究的主要特征,为中国间充质干细胞领域的发展提供建议。方法：检索SCI论文数据、DII专利数据及Clinical Trials临床试验数据及新药审批情况,利用Excel、DDA工具对检索结果进行定量分析和讨论。结果：中国在间充质干细胞基础研究、专利申请及临床试验方面虽起步较晚,但近年来发展迅速,论文、专利和临床试验数量快速增长,2014年起发表论文数量及2016年申请专利数量均超过美国,临床试验注册已达200余项;在骨质疏松、脊髓损伤等研究领域,内分泌系统疾病、自体免疫疾病等临床试验方面形成一定优势,已具备坚实的团队与技术基础。但我国间充质干细胞研究仍面临激烈的竞争,存在进步与发展空间。结论：我国间充质干细胞研究应发挥已有优势,加强战略性布局;重视发展以企业为主导的新药开发路径;做精做细以增强国际竞争力与影响力;加大资金投入和产业政策的支持;健全监管机制及评价体系,抓住机遇的同时积极迎接挑战。

关键词： 间充质干细胞; 再生医学; 临床试验

Abstract:

Objective: Compare the development status and trends of mesenchymal stem cells (MSCs) in basic research, patent application and clinical trial registration between China and the US. Find out the main characteristics of MSCs research in these two countries and provide suggestions for Chinese MSCs development. Methods: The paper data in SCI database, the patent data in DII database and the clinical trial data in Clinical Trials database are retrieved. The quantitative analysis is carried out by Excel and DDA. SWOT analysis is used to discuss the advantages and disadvantages, opportunities and threats of Chinese MSCs development. Results: Although China started late on MSCs research, it has developed rapidly in recent years. The number of papers since 2014 and patent applications in 2016 exceeds that of the United States, and the number of clinical trials has reached more than 200. China has advantages in the research fields of osteoporosis and spinal cord injury and some clinical trials such as endocrine system diseases and autoimmune diseases. However, there is still room for improvement in the study of MSCs in China. Conclusion: China should give full play to its existing advantages and strengthen the strategic layout; attach importance to the enterprise-led new drug development path; make efforts to enhance its international competitiveness and influence; increase capital investment and support of industrial policies and improve the regulatory mechanism and evaluation system.

Key words: Mesenchymal stem cells Regenerative medicine Clinical trial

收稿日期: 2019-09-10 出版日期: 2020-05-18

ZTFLH:

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通讯作者: 吴昊 E-mail: wuh@mail.las.ac.cn

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引用本文:

苑亚坤,刘广洋,刘拥军,谢亚芳,吴昊. 间充质干细胞基础研究与临床转化的中美比较[J]. 中国生物工程杂志, 2020, 40(4): 97-107.

YUAN Ya-kun,LIU Guang-yang,LIU Yong-jun,XIE Ya-fang,WU Hao. Comparison of Research and Clinical Transformation on Mesenchymal Stem Cells between China and the US. China Biotechnology, 2020, 40(4): 97-107.

链接本文:

https://manu60.magtech.com.cn/biotech/CN/10.13523/j.cb.1909020 或 https://manu60.magtech.com.cn/biotech/CN/Y2020/V40/I4/97

图1 间充质干细胞生物学特性

图2 间充质干细胞相关论文发表数量变化趋势

图3 近十年中美发表间充质干细胞相关论文数量变化趋势

表1 近十年中美发文数量排名前10的机构

图4 近十年中美发表间充质干细胞论文的关键词云图

图5 间充质干细胞领域专利申请数量发展趋势

图6 中美间充质干细胞领域专利申请数量趋势

表2 中美间充质干细胞专利主要技术领域分布

图7 中美间充质干细胞临床试验注册数量趋势

图8 中美间充质干细胞临床试验阶段分布

表3 中美间充质干细胞注册临床试验主要申办机构

表4 中美间充质干细胞注册临床试验状态分布

表5 中美新药监管差异

表6 我国间充质干细胞新药受理品种目录(2018~2019.8)

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