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Puvitinib (DR-101) is an orally bioavailable small molecule tyrosine kinase inhibitor (TKI) specifically targeting the Human Epidermal Growth Factor Receptor 2 (HER2). Developed by Hangzhou Derun Yucheng Biotechnology, it is designed to treat patients with HER2-positive advanced solid tumors who have failed or are not suitable for standard therapies. By inhibiting the phosphorylation of HER2, puvitinib disrupts downstream signaling cascades such as the PI3K/Akt and MAPK pathways, which are critical for tumor cell growth and survival. It has undergone Phase 1 clinical evaluation in China to determine its safety profile, pharmacokinetics, and preliminary efficacy.
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