石药集团(01093.HK)试验性新药获美国临床试验批件
石药集团(01093.HK)公布,附属NovaRock Biotherapeutics研发的全人源抗体药物NBL-015的试验性新药(IND)申请已获FDA(美国食品药品监督管理局)批准。此I期临床试验将会评估NBL-015对晚期实体瘤患者的安全性、耐受性和药代动力学特性。
NBL-015是一种全人源抗Claudin 18.2单克隆抗体,用於治疗Claudin 18.2阳性表达的晚期实体瘤,包括胰腺癌、胃部、食道或食道胃结合部腺癌。
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