智通财经APP讯，轩竹生物-B(02575)发布公告，集团从临床阶段肿瘤公司AkamisBioLtd.(Akamis)授权引进的产品NG-350A获得美国食品药品监督管理局(FDA)授予快速通道资格(FastTrackdesignation)，用于治疗错配修复功能完整(pMMR)的局部晚期直肠癌(LARC)。集团拥有NG-350A产品的大中华区开发、生产与商业化的独家权利。
FDA快速通道资格认定是一种加速开发和审批潜在药物的方法。被授予快速通道资格认定的药物旨在治疗严重疾病并解决未满足的医疗需求，其可能是针对特定疾病的首个疗法，或与现有疗法相比更具显着临床优势，或提高现有疗法的安全性。
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