智通财经APP获悉，信达生物(01801)涨近3%，截至发稿，涨2.2%，报83.6港元，成交额2.04亿港元。
消息面上，据信达生物官微消息，2026年1月27日，公司宣布其抗GPRC5D/BCMA/CD3三特异性抗体IBI3003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)，拟定适应症为接受过含一种蛋白酶体抑制剂(Pl)、一种免疫调节药物(IMiD)及一种抗CD38单抗的至少四线治疗的复发或难治性多发性骨髓瘤(R/R MM)。IBI3003由信达生物专属Sanbody®平台构建，目前正在中国、澳大利亚和美国(即将启动)开展I/II期临床研究探索在R/R MM的有效性和安全性。
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