Adagene公司Muzastotug获FDA支持 即将启动MSS结直肠癌II期临床试验

华尔街洞察
Jul 15

生物医药企业Adagene公司(纳斯达克代码:ADAG)日前迎来重要监管突破。在与美国食品药品监督管理局(FDA)完成B类会议后,该公司宣布获得FDA书面支持,将推进其核心候选药物Muzastotug(ADG126)与默沙东抗PD-1疗法可瑞达®(KEYTRUDA®)的联合用药方案,用于治疗微卫星稳定结直肠癌(MSS CRC)。

根据FDA认可的临床开发计划,双方已就II期临床试验的入组标准、研究终点及试验设计达成共识。Adagene公司计划于2025年下半年正式启动患者招募工作。这项关键进展标志着该联合疗法向注册性临床试验迈出重要一步,默沙东将为此次研究提供帕博利珠单抗药物支持。

本资讯旨在传递前沿医疗研发动态,不构成任何投资建议。信息原始发布方对内容完整性承担全部责任。

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