赛生药业(06600.HK)：药监局受理抗菌药物临床试验申请

阿斯达克财经2022-12-28

赛生药业(06600.HK) 公布，国家药监局药品审评中心(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，其目的是评估药物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，以评估其药代动力学特征。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，并支持药物...

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