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Zongertinib is a novel human epidermal growth factor receptor 2 (HER2) selective tyrosine kinase inhibitor. In August 2025, zongertinib was approved by the US FDA for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain mutations and who have received prior systemic therapy. Clinical studies have shown that zongertinib has good efficacy and a manageable safety profile. Common adverse reactions of zongertinib include diarrhea, hepatotoxicity, and rash, etc.

, authors=Fang ZHANG¹, Tao-hua SUN², An-jin CHEN^{2, *}, authorsList=Fang ZHANG, Tao-hua SUN, An-jin CHEN, authorCompany=null, correspAuthors=An-jin CHEN, 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=1321425628302266956, articleId=1321425626393858633, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=首个治疗HER2突变非小细胞肺癌的口服药：zongertinib, columnId=1236331162679955859, journalTitle=中国新药杂志, columnName=新药述评与论坛, runingTitle=null, highlight=null, articleAbstract=

zongertinib是一种HER2选择性酪氨酸激酶抑制剂。美国FDA于2025年8月批准zongertinib用于HER2酪氨酸激酶结构域突变且既往接受过全身治疗的不可切除或转移性非鳞状非小细胞肺癌（NSCLC）成人患者的治疗。临床研究表明，zongertinib具有良好的疗效且安全性可控。zongertinib常见不良反应包括腹泻、肝毒性和皮疹等。

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张芳，女，主任药师，主要从事医院药学相关研究。E-mail: 474285027@qq.com。

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张芳，女，主任药师，主要从事医院药学相关研究。E-mail: 474285027@qq.com。

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