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Denlorlatinib (formerly SY-5007) is a potent, selective, and brain-penetrant small-molecule tyrosine kinase inhibitor (TKI) targeting Anaplastic Lymphoma Kinase (ALK) and ROS proto-oncogene 1 (ROS1). Developed by Nanjing Zaiming Pharmaceutical, a subsidiary of Simcere, the drug is designed to overcome resistance mutations common in earlier-generation ALK inhibitors and features high blood-brain barrier permeability to effectively treat central nervous system (CNS) metastases. It is currently in Phase 3 clinical development for the first-line treatment of ALK-positive non-small cell lung cancer (NSCLC) and is also being investigated for ROS1-positive advanced solid tumors.
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