中国同辐(01763.HK)附属治疗用碘化钠胶囊获授药品注册证书
中国同辐(01763.HK)公布,附属原子高科近日取得了国家食品药品监督管理局颁发的「治疗用碘化钠胶囊」药品注册证书。品种为自2005年以来首个在国内获批的仿制国外已上市药品的放射性药物新制剂(首仿)品种,是公司在新药品注册法规颁布後申报成功的首个产品,也是作为口服固体制剂视同为通过一致性评价的首个品种。
集团指,治疗用碘化钠胶囊的获批将对公司放射性药品研发、注册、生产及销售起到推动作用,有望带动公司销售收入及利润增加;对国内放射性药物产业及核医学的发展具有特殊重要意义。
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