智通财经APP获悉,翰森制药(03692)盘中涨近3%,截至发稿,涨2.35%,报18.3港元,成交额6043.31万港元。
消息面上,3月4日,据中国国家药监局药品审评中心官网公示,由Horizon Therapeutics、阿斯利康(AZN.US)和翰森制药(03692)共同申报伊奈利珠单抗注射液一项新适应症上市申请获得受理。伊奈利珠单抗是一款抗CD19单抗,该产品于今年2月刚刚被CDE正式纳入优先审评,用于免疫球蛋白G4相关疾病(IgG4-RD)成人患者的治疗。由此推测,这可能就是本次该产品申报上市的适应症。
据悉,伊奈利珠单抗是靶向CD19 B细胞消耗性抗体。2019年,翰森制药与Viela Bio订立许可协议,获得于中国内地、香港和澳门地区开发及商业化该产品的独家许可(Viela Bio于2021年被Horizon Therapeutics收购,后者于2023年被安进收购)。伊奈利珠单抗此前已经在美国和中国获批上市,用于治疗抗水通道蛋白4(AQP4)抗体阳性的视神经脊髓炎谱系障碍(NMOSD)成人患者。
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