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石药(01093.HK)晚期实体瘤药物I期临床试验完成首例患者给药
阿思达克 03-30 18:55
石药集团(01093.HK)公布,附属公司石药集团中奇制药技术开发的「注射用多西他赛(白蛋白结合型)」已为参与美国I期临床试验的首例患者完成给药。该项研究之目的为评估多西他赛新剂型针对晚期实体瘤的安全性、耐受性、药物代谢动力学及初步疗效。

该产品采用创新的人血白蛋白包裹技术,将多西他赛纳米粒输送至患者体内。凭藉该项技术,多西他赛(白蛋白结合型)将可避免现时市场上多西他赛产品注射前的预先给药、减少与注射有关的过敏反应以及提高患者依从性。在临床前研究中,多西他赛(白蛋白结合型)在多种动物模型中显示了安全性及对多种实体瘤增强的抗肿瘤疗效。集团及其他制药公司於市场上销售的紫杉醇产品已采用了相似的白蛋白包裹技术。

集团正同时在中国及美国进行该产品的临床开发。初始的实体瘤适应症包括胃癌及前列腺癌。集团将致力加快单药使用及与PD-1靶向药物联合使用的临床试验。

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