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2025-05-28

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...

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