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东曜药业-B(01875.HK)治疗多形性胶质母细胞瘤仿制药获内地药品注册批件
阿思达克 05-31 12:21
东曜药业-B(01875.HK)公布,公司自主研发的替莫唑胺胶囊(TOZ309,拟使用商标名称为「替至安 Tazian」)已获得国家药品监督管理局药品注册批件。该产品为视同通过质量和疗效一致性评价的仿制药,可在中国境内(即不包括香港、澳门和台湾地区)上市,用於治疗新诊断的多形性胶质母细胞瘤,开始先与放射治疗联合治疗,随後作为维持治疗;及常规治疗後复发或进展的多形性胶质母细胞瘤或间变性星形细胞瘤。

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