百济神州:BGB-16673获欧洲药品管理局优先药物认定,用于治疗华氏巨球蛋白血症
Xin Lang Cai Jing·2025-07-31 10:19

Core Insights - BeiGene has received Priority Medicine (PRIME) designation from the European Medicines Agency (EMA) for its investigational Bruton’s Tyrosine Kinase (BTK) degrader BGB-16673, aimed at treating patients with Waldenström's macroglobulinemia (WM) who have previously been treated with BTK inhibitors [1] - The EMA's Committee for Medicinal Products for Human Use (CHMP) has also issued a positive opinion regarding the orphan drug designation (ODD) application for BGB-16673 for the treatment of WM patients, with a final decision expected in the coming weeks [1]