On February 10, the latest announcement from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration indicated that the orally disintegrating tablet formulation of zolotrectinib, submitted by Innocare, is recommended for priority review. The proposed indication is for pediatric solid tumor patients aged 2 to 12 years who meet the following criteria: carrying a neurotrophic tyrosine receptor kinase (NTRK) fusion gene; suffering from locally advanced or metastatic disease, or where surgical resection may lead to severe complications; and having no satisfactory alternative treatments or having failed previous therapies. Zolotrectinib (ICP-723) is a new-generation TRK inhibitor. Its indication for treating solid tumors in adults and adolescents over 12 years old with NTRK fusion genes was already approved for marketing in China in December 2025. NTRK fusion genes are present in various types of tumors and have currently been identified in over 26 different solid tumors. According to public information from Innocare, as a new-generation TRK inhibitor, zolotrectinib not only provides long-term deep remission and has strong brain penetration activity with an overall favorable safety profile, but data also show it can overcome resistance to first-generation TRK inhibitors. The convenient once-daily, two-tablet oral administration regimen also offers significant benefits for patients. In October 2025, Innocare announced that results from a Phase 1/2 study of zolotrectinib in pediatric and adolescent patients with advanced solid tumors were selected for an oral presentation at the 2025 International Society of Paediatric Oncology (SIOP) Annual Congress. The study results demonstrated that zolotrectinib showed a favorable safety profile and prominent antitumor activity in pediatric/adolescent patients with NTRK/ROS1 fusion-positive solid tumors, indicating its potential as a therapy for malignancies driven by NTRK/ROS1 genes, particularly showing good efficacy in overcoming resistance to first-generation TRK inhibitors. The main tumor types among enrolled patients included NTRK-rearranged spindle cell tumors and primary central nervous system tumors. The recommended Phase 2 dose (RP2D) for pediatric and adolescent patients was 7.2 mg/m² once daily and 8 mg once daily, respectively. Pharmacokinetic data at the recommended dose showed similar drug exposure in children and adolescents compared to adults. As of July 31, 2025, the objective response rate (ORR) assessed by an independent review committee (IRC) in patients with NTRK fusion-positive tumors was 90%. All evaluable patients who had developed resistance to first-generation TRK inhibitors achieved partial response. Zolotrectinib demonstrated a favorable safety profile, with no dose-limiting toxicities observed, and treatment-related adverse events (TRAEs) were mostly Grade 1-2.