Innovation
InnoCare's Zurletrectinib Wins China Approval as Next-Generation TRK Inhibitor for NTRK Fusion-Positive Solid Tumors Beijing InnoCare Pharma has received approval from China's National Medical Products Administration for zurletrectinib (Yinuoxin/ICP-723), a next-generation TRK inhibitor for treating adults and adolescents aged 12 and older with NTRK fusion-positive solid tumors. Designed to overcome acquired resistance to first-generation TRK inhibitors, zurletrectinib demonstrated an overall response rate (ORR) of 89.1%, a disease control rate of 96.4%, a 24-month progression-free survival rate of 77.4%, and an overall survival rate of 90.8% in registration trials. The drug exhibited remarkable brain-penetrant activity, achieving a 100% intracranial ORR and a 100% 12-month intracranial duration of response. In pediatric and adolescent trials, the confirmed ORR reached 100%, with one patient who had progressed on a first-generation TRK inhibitor achieving a complete response. The safety profile was favorable, with predominantly Grade 1 or 2 treatment-related adverse events and low rates of dose interruption or discontinuation.