Zhi Tong Cai Jing·2025-12-11 10:45Core Insights - NMPA has approved the second-generation small molecule TRK inhibitor, Zoltracitinib (ICP-723), for treating adult and adolescent patients (12 years and older) with NTRK fusion gene-positive solid tumors [1] Group 1: Drug Efficacy and Safety - Zoltracitinib demonstrated exceptional efficacy with an objective response rate (ORR) of 89.1% and a disease control rate (DCR) of 96.4% in clinical trials for NTRK fusion-positive solid tumors [1] - The 24-month progression-free survival (PFS) rate is 77.4%, and the overall survival (OS) rate is 90.8% [1] - As a next-generation TRK inhibitor, Zoltracitinib shows improved efficacy over first-generation TRK inhibitors, with strong brain penetration and good overall safety [1] Group 2: Administration and Convenience - Zoltracitinib is administered orally once daily at a dosage of two tablets, providing significant convenience for patients [1] Group 3: Market Potential and Clinical Need - NTRK fusion genes have been identified in over 26 types of solid tumors, with an estimated 6,500 new cases carrying NTRK fusion genes in China each year [2] - Patients with NTRK fusion-positive tumors typically have a short survival period, rapid disease progression, and high disability rates, indicating an unmet clinical need due to low prevalence of next-generation sequencing (NGS) for diagnosis [2] Group 4: Future Developments - The company plans to submit a new drug application (NDA) for Zoltracitinib to treat pediatric patients (ages 2 to 12) soon, as it has been included in the "Starlight Program" aimed at encouraging the development of pediatric oncology drugs [1]