智通财经APP获悉,信达生物(01801)午后涨超7%,截至发稿,涨5.82%,报42.7港元,成交额4.37亿港元。
消息面上,信达生物公告称,伊匹木单抗注射液联合信迪利单抗用于可切除的微卫星高度不稳定型(“MSI-H”)或错配修复缺陷型(“dMMR”)结肠癌患者的新辅助治疗的新药上市申请已获中国国家药品监督管理局药品审评中心受理并纳入优先审评程序。
此外,2月24日,中国国家药监局药品审评中心官网最新公示,信达生物申报的1类新药IBI3002获批临床,拟开发治疗哮喘。根据信达生物公开资料,IBI3002是其自主研发的一款抗IL-4Rα/TSLP双特异性抗体,目前正在澳大利亚开展1期临床研究。本次是该产品首次在中国获批IND。
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