智通财经APP获悉,荣昌生物(09995)涨近10%,截至发稿,涨9.92%,报28.25港元,成交额1.88亿港元。
消息面上,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。
交银国际认为,泰它西普gMGIII期数据优于已上市竞品,且商业化推广策略清晰。在中国内地,泰它西普的gMG适应症上市申请已于2024年10月获受理并纳入优先审评,公司对于该适应症的商业化策略包括:1)增加神经免疫领域专线代表,覆盖更多目标市场(包括VYVGART的现有重点目标医院);2)加强医生教育,重点推广泰它西普相比VYVGART的核心竞争优势;3)鼓励临床专家探索更多病例,收集医生反馈,建立专家分享平台。基于优异的临床数据和清晰的商业化推广策略,该行看好gMG获批后对泰它西普销售放量的长期推动作用。
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