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Zongertinib (HERNEXEOS®) is a small molecule, irreversible, HER2-specific tyrosine kinase inhibitor being developed by Boehringer Ingelheim for the treatment of advanced solid tumours with HER2 aberrations. Zongertinib selectively inhibits HER2-expressing cells, including those with HER2 mutations, while sparing cells expressing wild-type EGFR. It received its first approval under accelerated approval in August 2025 in the USA following positive results from the Beamion LUNG-1 phase Ia/Ib trial in patients with previously treated HER2-mutant non-small cell lung cancer (NSCLC). This article summarizes the milestones in the development of zongertinib leading to this first approval for the treatment of adult patients with unresectable or metastatic NSCLC whose tumours have HER2 tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy.
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The effect of carbamazepine, a strong CYP3A inducer, on the pharmacokinetics of zongertinib in healthy male volunteersTian, X., et al., 卡马西平（一种强CYP3A诱导剂）对健康男性受试者中宗格替尼药代动力学的影响。Pharmacotherapy, 2025. 45(2): p. 94-103..png)
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收藏HER2-Selective Tyrosine Kinase Inhibitor, Zongertinib (BI 1810631), in Patients With Advanced/Metastatic Solid Tumors With
HER2
Alterations: A Phase Ia Dose-Escalation StudyHeymach, J.V.等，HER2选择性酪氨酸激酶抑制剂Zongertinib（BI 1810631）在患有晚期/转移性实体瘤患者中的应用。J Clin Oncol, 2025. 43(11): p. 1337-1347.
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分享收藏Relative Bioavailability of Zongertinib, an Orally Administered HER2-Selective Tyrosine Kinase Inhibitor, under Fed and Fasted Conditions in Healthy Male Participants: Results from Two Randomized, Open-Label, Crossover Studies佐格替尼（Zongertinib）的相对生物利用度研究，佐格替尼是一种口服给药的HER2选择性酪氨酸激酶抑制剂，在进食和空腹条件下的研究：两项随机、开放标签、交叉研究的结果.png)
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分享收藏HER2 in Non-Small Cell Lung Cancer (NSCLC): Evolution of the Therapeutic Landscape and Emerging Drugs—A Long Way to the TopHER2在非小细胞肺癌（NSCLC）中的治疗格局演变及新兴药物——任重道远Molecules
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