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Sacibertinib (Hemay022) is a novel, orally available, irreversible small-molecule tyrosine kinase inhibitor targeting both the epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2). It covalently binds to and inhibits EGFR and HER2, blocking their signaling pathways and thereby exerting antitumor effects. Sacibertinib has demonstrated anti-tumor activity in preclinical studies and early-phase clinical trials, particularly in patients with HER2-positive advanced breast cancer who have failed standard therapies. When combined with endocrine therapy such as fulvestrant, it is being investigated for enhanced efficacy in hormone receptor-positive/HER2-positive breast cancer. The drug was developed by Tianjin Hemay Biotech and is currently undergoing phase III clinical evaluation for HER2-positive breast cancer[1][2][5][6][7].
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