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Trastuzumab Deruxtecan has broad application prospects in the treatment of HER2-related tumors. The analysis of patent information can facilitate the research and innovation of this class of drugs. Through patent search and literature review, the molecular patents for the trastuzumab component have expired. The related patents for the linker and the cytotoxic drug remain valid. All the related patents of trastuzumab deruxtecan are valid, and its patent layout structure is reasonable. A progressive application strategy of "structure-process-indication-combination therapy" has been adopted to continuously extend the patent life. From the perspective of patent analysis, this provides new drug research pathways for innovative entities. First, make full use of the antibody drugs whose patent terms have expired; second, retain the GGFG tetrapeptide in the linker and substantially improve the molecular structure of other parts. Taking trastuzumab rezetecan as an example, through creative structural modifications, this strategy is expected to break through the patent barriers of trastuzumab deruxtecan.

, authors=Xiao-liang FENG, Zhi-fang WU, authorsList=Xiao-liang FENG, Zhi-fang WU, authorCompany=null, correspAuthors=null, 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=1321425895303263037, articleId=1321425894514733883, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=德曲妥珠单抗的专利布局分析, columnId=1236331162679955859, journalTitle=中国新药杂志, columnName=新药述评与论坛, runingTitle=null, highlight=null, articleAbstract=

德曲妥珠单抗在人表皮生长因子受体2(HER2)相关肿瘤治疗中具有广阔的应用前景,对其专利信息的分析有助于此类药物的研发和创新。通过专利检索与文献研究,德曲妥珠单抗中曲妥珠单抗的分子专利期限已届满。连接子、毒素药物的相关专利仍然有效。德曲妥珠单抗的相关专利全部有效,专利布局结构合理,采取“结构-工艺-适应证-联合用药”的递进式申请策略,持续延长专利生命。从专利分析角度,为创新主体提供新药研发思路:①充分利用专利期限届满的抗体药物。②保留连接子中的马来酰亚胺基己酸-甘氨酸-甘氨酸-苯丙氨酸-甘氨酸(GGFG)四肽,实质性改进其他部分的分子结构。以瑞康曲妥珠单抗为例,通过创造性的结构修饰,有希望突破德曲妥珠单抗的专利壁垒。

, authors=冯晓亮, 吴至芳, authorsList=冯晓亮, 吴至芳, authorCompany=null, correspAuthors=null, authorNote=

吴至芳,女,博士,知识产权师,研究方向:医药领域知识产权审查与分析。E-mail: 。

冯晓亮,男,硕士,副研究员,研究方向:医药领域知识产权审查与分析。E-mail: 。

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冯晓亮,男,硕士,副研究员,研究方向:医药领域知识产权审查与分析。E-mail: 。

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冯晓亮,男,硕士,副研究员,研究方向:医药领域知识产权审查与分析。E-mail: 。

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德曲妥珠单抗的专利布局分析
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冯晓亮 , 吴至芳
中国新药杂志 | 新药述评与论坛 2026,35(17): 1803-1810
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中国新药杂志 |新药述评与论坛 2026 , 35 (17) : 1803 -1810
德曲妥珠单抗的专利布局分析
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冯晓亮,男,硕士,副研究员,研究方向:医药领域知识产权审查与分析。E-mail: 。

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冯晓亮,男,硕士,副研究员,研究方向:医药领域知识产权审查与分析。E-mail: 。

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冯晓亮 , 吴至芳
作者信息
  • 国家知识产权局专利局专利审查协作北京中心,北京 100160
作者简介:

吴至芳,女,博士,知识产权师,研究方向:医药领域知识产权审查与分析。E-mail: 。

冯晓亮,男,硕士,副研究员,研究方向:医药领域知识产权审查与分析。E-mail: 。

Analysis on the patent layout of trastuzumab deruxtecan
Xiao-liang FENG , Zhi-fang WU
Affiliations
  • Patent Examination Cooperation (Beijing) Center of the Patent Office, CNIPA, Beijing 100160, China
出版时间: 2026-09-15 doi: 10.20251/j.cnki.1003-3734.2026.17.002
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德曲妥珠单抗在人表皮生长因子受体2(HER2)相关肿瘤治疗中具有广阔的应用前景,对其专利信息的分析有助于此类药物的研发和创新。通过专利检索与文献研究,德曲妥珠单抗中曲妥珠单抗的分子专利期限已届满。连接子、毒素药物的相关专利仍然有效。德曲妥珠单抗的相关专利全部有效,专利布局结构合理,采取“结构-工艺-适应证-联合用药”的递进式申请策略,持续延长专利生命。从专利分析角度,为创新主体提供新药研发思路:①充分利用专利期限届满的抗体药物。②保留连接子中的马来酰亚胺基己酸-甘氨酸-甘氨酸-苯丙氨酸-甘氨酸(GGFG)四肽,实质性改进其他部分的分子结构。以瑞康曲妥珠单抗为例,通过创造性的结构修饰,有希望突破德曲妥珠单抗的专利壁垒。

德曲妥珠单抗  /  甘氨酸-甘氨酸-苯丙氨酸-甘氨酸四肽  /  抗体药物偶联物  /  专利布局  /  新药研发

Trastuzumab Deruxtecan has broad application prospects in the treatment of HER2-related tumors. The analysis of patent information can facilitate the research and innovation of this class of drugs. Through patent search and literature review, the molecular patents for the trastuzumab component have expired. The related patents for the linker and the cytotoxic drug remain valid. All the related patents of trastuzumab deruxtecan are valid, and its patent layout structure is reasonable. A progressive application strategy of "structure-process-indication-combination therapy" has been adopted to continuously extend the patent life. From the perspective of patent analysis, this provides new drug research pathways for innovative entities. First, make full use of the antibody drugs whose patent terms have expired; second, retain the GGFG tetrapeptide in the linker and substantially improve the molecular structure of other parts. Taking trastuzumab rezetecan as an example, through creative structural modifications, this strategy is expected to break through the patent barriers of trastuzumab deruxtecan.

trastuzumab deruxtecan  /  GGFG  /  antibody drug conjugate  /  patent layout  /  new drug research
冯晓亮, 吴至芳. 德曲妥珠单抗的专利布局分析. 中国新药杂志, 2026 , 35 (17) : 1803 -1810 . DOI: 10.20251/j.cnki.1003-3734.2026.17.002
Xiao-liang FENG, Zhi-fang WU. Analysis on the patent layout of trastuzumab deruxtecan[J]. Chinese Journal of New Drugs, 2026 , 35 (17) : 1803 -1810 . DOI: 10.20251/j.cnki.1003-3734.2026.17.002

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doi: 10.20251/j.cnki.1003-3734.2026.17.002
  • 首发时间:2026-10-26
  • 出版时间:2026-09-15
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  • 录用日期:2025-09-28
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    国家知识产权局专利局专利审查协作北京中心,北京 100160
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2种不同金属材料的力学参数
科
Family
属数
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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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