远大医药(00512):集团核药研发及生产基地取得甲级《辐射安全许可证》并即将投入运营

金吾财讯
19 May

金吾财讯 | 远大医药(00512)公告,集团位于成都市温江区的全球领先的核药研发及生产基地,近日获得中国生态环境部颁发的甲级《辐射安全许可证》,并将于今年6月正式投入运营。该基地于2022年底签约,2023年四月全面启动环境影响评估,同年十一月获得施工许可正式破土动工,仅五个月实现主体封顶,以两年周期刷新行业建设纪录。该研发及生产基地作为全球首个核药全产业链闭环平台,总规划投资拟超30亿元人民币,聚焦同位素工艺开发与制备、核药偶联技术、自动化标记技术等核心领域,覆盖核药早研、工艺开发、质量研究、非临床研究、智能生产与精准配送一站式全生命周期管理,树立了世界一流研发生产质量与运营体系,基地建设有14条符合药品生产质量管理规范(GMP)要求的生产线,并构建了全链条AI运营体系和智能制造体系,可实现多种同位素和多种核药制剂的自主生产,同时预留α核素药物生产线,是目前国际范围内核素种类最全、自动化程度最高的智能工厂之一,可充分满足集团治疗性与诊断性核药的多品种、规模化制备需求。

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