【港股通】赛生药业(06600)跌转涨2.97% 国家药监局受理Vaborem临床试验申请

凤凰网港股
Dec 29, 2022

赛生药业(06600)早盘触底反弹,最新报8.66港元,跌转涨2.97%,成交额2655万港元。公司公布,中国国家药品监督管理局药品审评中心(CDE)正式受理公司新型抗菌药物Vaborem(注射用美罗培南韦博巴坦)的临床试验(IND)申请。此临床试验申请包括一项III期临床研究,其目的是评估Vaborem在中国复杂尿路感染((cUTI),包括肾盂肾炎)患者中的疗效和安全性;以及一项针对中国健康志愿者的药代动力学研究,以评估Vaborem的药代动力学特征。这两项在中国开展的临床研究用于桥接国外临床试验数据,并支持Vaborem最终在中国的上市申请。

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