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HEMAY022+AI is a combination therapy consisting of sacibertinib (Hemay022), an irreversible dual tyrosine kinase inhibitor (TKI) targeting the epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2), and an aromatase inhibitor (AI), such as exemestane or letrozole. Developed by Tianjin Hemay Pharmaceutical, this combination is designed to treat postmenopausal women with hormone receptor-positive (ER+) and HER2-positive locally advanced or metastatic breast cancer. The rationale for the combination is to simultaneously block the HER2/EGFR signaling pathways and the estrogen-driven growth pathway, which are often co-activated and contribute to resistance in this subtype of breast cancer. It is currently being evaluated in a Phase III clinical trial (Fillful-03) comparing its efficacy and safety against the combination of lapatinib and capecitabine in patients who have progressed on trastuzumab-containing regimens.
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