Zhi Tong Cai Jing·2025-12-12 06:13Core Viewpoint - Nocera Biopharma (09969) has seen a stock increase of over 3% following the approval of its drug, ICP-723, by the National Medical Products Administration (NMPA) for treating adult and adolescent patients with NTRK fusion gene solid tumors [1] Company Summary - Nocera Biopharma's ICP-723, a second-generation small molecule pan-TRK inhibitor, has been approved for use in patients aged 12 and older with NTRK fusion gene solid tumors [1] - The drug has been included in the NMPA's "Starlight Program," aimed at encouraging the development of pediatric oncology drugs [1] - The company plans to submit a New Drug Application (NDA) for ICP-723 to treat pediatric patients aged 2 to 12 years soon [1] Industry Summary - NTRK fusion genes are present in various tumor types, with over 26 solid tumors identified to date [1] - An estimated 6,500 new cases of tumors carrying NTRK fusion genes are diagnosed annually in China, characterized by short survival, rapid disease progression, and high disability rates [1] - The low prevalence of next-generation sequencing (NGS) as the gold standard diagnostic method has led to delayed diagnoses, indicating an unmet clinical need in this area [1]