华润三九拥有大中华区独家权益的“first-in-class”脑胶质瘤创新药获FDA加速批准上市

华润三九2025-08-08

当地时间8月6日，美国食品药品监督管理局（FDA）宣布加速批准dordaviprone（研发代号：ONC201）上市，适应症为“1岁及以上成人和儿童复发性 H3K27M突变弥漫性中线脑胶质瘤”，这也是FDA首次批准用于该适应症的药物上市。华润三九拥有ONC201在大中华区（含中国大陆、香港、澳门、台湾）的独家开发、生产及商业化权益，目前正在国内开展Ⅰ/Ⅱ期临床研究。公开信息显示，脑胶质瘤是最常见的...

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华润三九拥有大中华区独家权益的“first-in-class”脑胶质瘤创新药 获FDA加速批准上市

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华润三九拥有大中华区独家权益的“first-in-class”脑胶质瘤创新药获FDA加速批准上市