智通财经APP讯,中国生物制药(01177)公布,该集团自主研发的“TQB2101 (ROR1 ADC)”已获得中国国家药品监督管理局(NMPA)的临床试验默示许可,拟用于治疗晚期恶性肿瘤。
临床前研究数据显示,TQB2101在多种ROR1阳性肿瘤模型中展现出抗肿瘤活性,且具有良好的安全性特征。此次获批的I期临床试验将重点评估其在人体内的安全性、耐受性、药代动力学特性及初步疗效。
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