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海和药物紫杉醇口服溶液中国上市许可申请获正式受理

2022-09-14


2022年9月13日,上海海和药物研究开发股份有限公司和韩国大化制药公司共同宣布,双方合作开发的紫杉醇口服溶液已正式获得国家药品监督管理局药品审评中心的上市许可申请受理。本次适应症的中国上市申请主要是基RMX3001/DHP107C2301一项随机、开放、平行对照、非劣效设计、多中心III期临床试验,旨在比较紫杉醇口服溶液与紫杉醇注射液二线治疗晚期胃癌患者的疗效和安全性。该研究由上海市东方医院李进教授和南京金陵医院秦叔逵教授共同担任主要研究者,表示: “紫杉醇口服溶液采用专利的自乳化药物递送技术,疗效确切,避免了普通注射剂型溶剂Cremophor EL带来的一些毒副反应,且使用方便。

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