soxataltinib

Soxataltinib (SY-5007) is a novel, orally bioavailable, and highly selective small-molecule inhibitor of the RET (Rearranged during Transfection) kinase. Developed by Shouyao Holdings, it is designed to target oncogenic RET gene fusions, which serve as critical molecular drivers in approximately 1–2% of non-small cell lung cancer (NSCLC) cases and other malignancies. In a pivotal Phase III trial (NCT06031558), soxataltinib demonstrated significant clinical efficacy in treatment-naive patients with RET fusion-positive advanced NSCLC, achieving high objective response rates and durable disease control with a manageable safety profile. Its selectivity for RET kinase aims to minimize off-target toxicities associated with multi-kinase inhibitors.