智通财经网·2025-12-11 10:40Core Viewpoint - The approval of the second-generation TRK inhibitor, Zoltracitinib (ICP-723), by the National Medical Products Administration (NMPA) marks a significant advancement in the treatment of adult and adolescent patients with NTRK fusion gene-positive solid tumors, showcasing high efficacy and safety [1][2]. Group 1: Company Developments - Zoltracitinib has demonstrated 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 reported at 77.4%, while the overall survival (OS) rate stands at 90.8% [1]. - The drug is included in the "Starlight Program," aimed at encouraging the development of pediatric oncology drugs, with plans to submit a new drug application (NDA) for treating children aged 2 to 12 years soon [1]. Group 2: Industry Context - NTRK fusion genes have been identified in over 26 types of solid tumors, with an estimated 6,500 new cases in China each year [2]. - Patients with NTRK fusion-positive tumors typically experience short survival, rapid disease progression, and high disability rates, highlighting an unmet clinical need due to delays in diagnosis from low prevalence of next-generation sequencing (NGS) [2].