信达生物(01801)盘中涨超4%,截至发稿,股价上涨3.47%,现报38.80港元,成交额3.97亿港元。
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。
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