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荣昌生物(09995)午前股价上涨11.48%,现报28.65港元,成交额2.20亿港元。
近日,荣昌生物宣布其自主研发的BLyS/APRIL双靶点融合蛋白创新药泰它西普(telitacicept,RC18)用于治疗全身型重症肌无力(gMG)3期研究结果,以“最新突破性研究”口头报告亮相美国神经病学学会(AAN)年会。数据显示,泰它西普治疗24周后,98.1%的患者重症肌无力日常活动评分(MG-ADL)改善≥3分,87%的患者定量重症肌无力评分(QMG)改善≥5分,具有显著的临床意义。目前,泰它西普用于治疗全身型重症肌无力的上市申请已于2024年10月获CDE受理,并被纳入优先审评,预计于今年二季度在中国获批上市。
华安证券4月01日发布研报称,给予荣昌生物买入评级。评级理由主要包括:1)收入增加,投入趋于稳定,费用率大幅降低;2)肿瘤自免商业化经验累积,准入医院数量不断扩大;3)泰它西普适应症拓展,陆续推进给药随访;4)在研管线布局ADC及双抗,2期临床进行中。风险提示:销售不及预期风险;研发审批进度不及预期风险;新药研发失败风险;政策不确定风险。
责任编辑:卢昱君
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