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ZL-2302 is an investigational, orally bioavailable small molecule tyrosine kinase inhibitor (TKI) that dual-targets Anaplastic Lymphoma Kinase (ALK) and ROS1 proto-oncogene receptor tyrosine kinase. Developed by Shanghai Xuantai Haimen Pharmaceutical Co., Ltd., the drug is specifically designed to treat advanced non-small cell lung cancer (NSCLC) in patients harboring ALK or ROS1 gene rearrangements. As a next-generation inhibitor, ZL-2302 aims to overcome resistance mutations, such as the ALK G1202R mutation, which frequently emerge following treatment with first- and second-generation ALK inhibitors like crizotinib or alectinib. It is currently undergoing Phase 1/2 clinical trials in China to evaluate its safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy in patients with ALK-positive or ROS1-positive solid tumors.
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