罗氏(RHHBY.US)注射用维泊妥珠单抗新适应症国内上市申请获受理

智通财经

28 May

智通财经APP获悉，5月28日，CDE官网显示，罗氏(RHHBY.US)注射用维泊妥珠单抗（商品名：Polivy、优罗华）新适应症上市申请获受理。此前2023年1月，该产品已在中国获批两项适应症。今年4月，罗氏在一季度报中披露，2025年将递交维泊妥珠单抗联合莫妥珠单抗（CD20/CD3双抗）二线以上DLBCL适应症的上市申请。作为全球唯一一款获批的 CD79B ADC，25 年第一季度，该产品销售额为 3.58 亿瑞士法郎，同比增长 42%。

来源：CDE官网

维泊妥珠单抗是罗氏开发的一款靶向CD79B的ADC，2019年6月以加速批准的方式在美国获批上市，联合苯达莫司汀+利妥昔单抗用于既往至少接受过2种治疗方案的R/RDLBCL，目前已转为完全批准。2023年4月，该产品DLBCL适应症被拓展至一线。

2023年1月，维泊妥珠单抗进入中国市场，适应症为：1）联合利妥昔单抗、环磷酰胺、多柔比星和泼尼松适用于治疗既往未经治疗的DLBCL成人患者；2）联合苯达莫司汀和利妥昔单抗用于不适合接受造血干细胞移植的R/RDLBCL成人患者。

来源：罗氏财报

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