【百利天恒:GNC-038 四特异性抗体注射液项目治疗系统性红斑狼疮、类风湿关节炎获临床试验批准】金融界12月23日消息,百利天恒近日收到国家药品监督管理局正式批准签发的《药物临床试验批准通知书》,其自主研发的创新生物药GNC-038的药物临床试验获得批准。GNC-038是一种靶向CD3、4-1BB、PD-L1和CD19的创新重组人源化四特异性抗体,是全球首个进入临床开发的四特异性治疗性抗体。除新获批的2个适应症外,目前已开展了1个Ia/Ib期和4个Ib/II期临床研究,适应症为急性淋巴细胞白血病和非霍奇金淋巴瘤等血液系统肿瘤。但药品在获得批准通知书后,尚需开展临床试验并经批准方可生产上市,具有不确定性。

金融界
23 Dec 2024
金融界12月23日消息,百利天恒近日收到国家药品监督管理局正式批准签发的《药物临床试验批准通知书》,其自主研发的创新生物药GNC-038的药物临床试验获得批准。GNC-038是一种靶向CD3、4-1BB、PD-L1和CD19的创新重组人源化四特异性抗体,是全球首个进入临床开发的四特异性治疗性抗体。除新获批的2个适应症外,目前已开展了1个Ia/Ib期和4个Ib/II期临床研究,适应症为急性淋巴细胞白血病和非霍奇金淋巴瘤等血液系统肿瘤。但药品在获得批准通知书后,尚需开展临床试验并经批准方可生产上市,具有不确定性。

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