智通财经APP获悉，信达生物(01801)涨超4%，截至发稿，涨3.47%，报38.8港元，成交额3.03亿港元。
消息面上，2月17日，信达生物宣布PD-1/IL-2α-bias双特异性抗体融合蛋白IBI363获得美国食品和药物监督管理局(FDA)授予快速通道资格(fast track designation, FTD)，拟定适应症为抗PD-(L)1免疫检查点抑制剂及含铂化疗治疗后进展的局部晚期或转移性鳞状非小细胞肺癌。IBI363在多种晚期实体瘤中展现出了积极的疗效和安全性信号，目前信达生物正在中国和美国等同时开展IBI363的1/2期临床研究。
信达生物制药集团高级副总裁周辉博士表示："很高兴在继黑色素瘤后，IBI363再次获得治疗肺鳞癌的FDA快速通道资格认定。此前我们报道，在扩大样本量的鳞状非小细胞肺癌中，IBI363在更高的剂量下展现出更好的ORR和DCR趋势，以及可控的安全性。目前3mg/kg剂量组的PFS数据已成熟，进一步增加了我们对IBI363作为免疫疗法提升患者长期获益潜力的信心，我们将在今年的国际学术大会中公布相关数据。
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