格隆汇7月7日丨远大医药(00512.HK)公告，集团联营公司Sirtex Medical Pty Ltd的SIR-Spheres®钇[90Y]微球注射液近日获得美国食品药品监督管理局("FDA")正式批准新增适应症，用于治疗不可切除肝细胞癌。
此次提前正式获批是基于DOORwaY90临床试验的突破性中期数据成功达到预设的共同主要终点，标志着SIR-Spheres®钇[90Y]微球注射液成为全球首个且唯一获FDA批准用于不可切除HCC和结直肠癌肝转移双重适应症的选择性内放射治疗产品，相关临床数据也将为中国适应症拓展提供有力支援；同时，彰显了集团优秀的海外临床注册能力，为后续自研创新核药产品的海外开发工作提供重要保障。集团始终重视研发创新，依托核药全球化布局及自主可控的产业生态，已构建覆盖诊断治疗一体化、国内国际双循环的核医学创新矩阵，形成"研发-生产-销售"全产业链闭环体系。
未来，集团将持续推进核药抗肿瘤诊疗产品的全球拓展及商业化进程，巩固全球行业领先地位。
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