药企药品周讯 | 信达生物IBI363双抗新药首个全球多中心3期临床获美国FDA批准

生物经纬
Aug 27

018月25日,信达生物宣布其自主研发的PD-1/IL-2α-bias双特异性抗体融合蛋白IBI363的首个全球3期临床研究(MarsLight-11)的新药临床试验申请(IND)获美国FDA批准,用于治疗免疫耐药的鳞状非小细胞肺癌(NSCLC)患者,标志着这一创新性双免疫疗法的全球开发取得重要进展。IBI363治疗黑色素瘤的中国关键注册研究也已在进行中。028月22日,第一三共(Daiichi ...

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