Ge Long Hui A P P·2025-12-11 10:59Core Viewpoint - The approval of Zolbetuximab (ICP-723) as the first domestically developed next-generation TRK inhibitor in China represents a significant advancement in treatment options for adult and adolescent patients with NTRK fusion gene-positive solid tumors [1][2] Group 1: Product Approval - The National Medical Products Administration (NMPA) has granted approval for Zolbetuximab (宜诺欣®), making it the first next-generation TRK inhibitor approved in China [1] - The drug is specifically indicated for adult and adolescent patients aged 12 and above with solid tumors carrying NTRK fusion genes [1] Group 2: Clinical Need - NTRK fusion genes are found in over 26 types of solid tumors, with an estimated 6,500 new cases in China each year [1] - Patients with NTRK fusion-positive tumors typically have a short survival period, rapid disease progression, and high disability rates, highlighting an unmet clinical need due to delayed diagnosis from low prevalence of next-generation sequencing (NGS) [1] Group 3: Clinical Trial Results - In pivotal registration trials, Zolbetuximab demonstrated an overall response rate (ORR) of 89.1% and a disease control rate (DCR) of 96.4% [2] - The 24-month progression-free survival (PFS) rate was 77.4%, and the overall survival (OS) rate was 90.8% [2] - Zolbetuximab shows superior efficacy compared to first-generation TRK inhibitors, with strong brain penetration and good overall safety [2] Group 4: Administration and Convenience - The drug is administered orally once daily, with a dosage of two tablets per administration, providing significant convenience for patients [2]