百奥泰BAT2506注射液上市许可申请获FDA受理

财中社2025-07-16

7月16日，百奥泰（688177）发布公告，近日收到BAT2506（戈利木单抗）注射液生物制品许可申请（BLA）获得美国FDA受理的通知。该药品为公司根据中国NMPA、美国FDA、欧洲EMA生物类似药相关指导原则开发的生物类似药，主要用于治疗中重度活动性类风湿关节炎、活动性银屑病关节炎、活动性强直性脊柱炎及中重度活动性溃疡性结肠炎等适应症。公告中提到，BAT2506的原研药为美国强生公司的...

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