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SY-12321 is an orally bioavailable, small molecule tyrosine kinase inhibitor (TKI) targeting the anaplastic lymphoma kinase (ALK) protein. Developed by First Pharmaceutical Holdings (Beijing), it is currently being evaluated in Phase I/II clinical trials for the treatment of ALK-positive advanced malignancies, including non-small cell lung cancer (NSCLC), inflammatory myofibroblastic tumors, and other ALK-driven solid tumors. The drug is designed to inhibit the signaling pathways activated by ALK fusion proteins or mutations, which drive tumor growth and survival. It is being studied in both ALK TKI-naive patients and those previously treated with other ALK inhibitors.
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