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东曜药业-B(01875.HK)替莫唑胺胶囊获批上市
格隆汇 05-31 12:23

格隆汇5月31日丨东曜药业-B(01875.HK)宣布,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®))(“该产品”)已获得国家药品监督管理局(“NMPA”)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,用于治疗:(1)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,随后作为维持治疗;及(2)常规治疗后复发或进展的多形性胶质母细胞瘤或间变性星形细胞瘤。

该产品是按照NMPA化学药品新4类仿制药申请上市,其规格包括20mgⅹ5粒╱瓶和100mgⅹ5粒╱瓶。

TOZ309替至安®是替莫唑胺胶囊“泰道®(TEMODAR®)的仿制药。替莫唑胺为咪唑并四嗪类具有抗肿瘤活性的烷化剂,可通过破坏DNA杀死癌细胞。与常规化化疗相比,随着疗效加强及副作用减少,替莫唑胺胶囊被用作新诊断及复发性脑胶质瘤的一线药物。

中国境内市场上仅有三款替莫唑胺胶囊,包括原研药“泰道®(TEMODAR®),其已于1999年获美国药品监督管理局批准,并于2007年获NMPA批准进入中国市场。根据弗若斯特沙利文的资料,替莫唑胺胶囊在中国境内市场的销售额于2018年达到人民币约18亿元,预期于2023年将增至人民币约25亿元。

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