东曜药业(01875.HK)贝伐珠单抗注射液新药上市申请获国家药监局受理
东曜药业(01875.HK)公布,集团自主研发的抗体药物TAB008在中国(不包括香港、澳门和台湾)的新药上市申请已经获中国国家药品监督管理局(NMPA)受理。
集团指,TAB008是以商品名称「安维汀(Avastin)」在中国出售的贝伐珠单抗注射液之生物类似药,是公司核心产品之一。集团拟使用「朴欣汀(Pusintin)」作为TAB008的商品名称。是次新药上市申请主要基於TAB008以安维汀为对照的两项临床研究所得临床数据,即在健康受试者中的药代动力学比对研究,和在晚期或复发性非鳞状非小细胞肺癌患者中的安全性及有效性的比对研究。两项研究均达到了预设的主要终点。
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