Zhong Zheng Wang·2025-08-29 07:45Core Insights - Nocera Biopharma's new pan-TRK inhibitor, zurletrectinib (ICP-723), has been included in China's National Medical Products Administration (NMPA) "Star Program" for pediatric oncology drug development [1][2] - The new drug application (NDA) for zurletrectinib targeting adult and adolescent patients with NTRK fusion gene-positive advanced solid tumors has been accepted in China and is under priority review [1] - Clinical trials for zurletrectinib in children aged 2 to 12 years are ongoing, with plans to submit the NDA by the second half of 2025 [1] Company and Industry Summary - The "Star Program" aims to enhance communication between drug applicants and the NMPA to improve the efficiency of pediatric oncology drug development [2] - Nocera Biopharma's CEO highlighted the prevalence of NTRK gene fusion in pediatric tumors and emphasized the recognition of the company's innovation capabilities through the inclusion of zurletrectinib in the program [2] - The clinical trials for zurletrectinib have demonstrated excellent efficacy and safety, overcoming resistance seen with first-generation TRK inhibitors [1]