来源：智通财经网 百奥泰(688177.SH)发布公告，公司于近日收到了欧洲药品管理局(以下简称"EMA")的通知， Gotenfia®(BAT2506，戈利木单抗注射液)获得EMA人用药品委员会(以下简称"CHMP")积极意见。 CHMP建议欧盟委员会(EC)批准Gotenfia®上市，用于治疗类风湿关节炎，幼年特发性关节炎，银屑病 关节炎，中轴型脊柱关节炎，溃疡性结肠炎。 BAT2506是百奥泰根据中国国家药品监督管理局(以下简称"NMPA")、美国食品药品监督管理局(以下简 称"FDA")、EMA生物类似药相关指导原则开发的戈利木单抗生物类似药。戈利木单抗是靶向TNF-α的 抗体，能够以高亲和力特异性地结合可溶性及跨膜的人TNF-α，阻断TNF-α与其受体TNFR结合，从而 抑制TNF-α的活性。 BAT2506(戈利木单抗注射液)的原研药为美国强生公司的Simponi® (欣普尼®)。根据强生公司2024年年 度报告，Simponi®2024年在全球的销售额为21.90亿美元。 ...

Core Viewpoint - The company has received notification from the FDA regarding the acceptance of the Biologics License Application (BLA) for BAT2506 (Golimumab injection), a biosimilar to Janssen's Simponi, which is projected to have global sales of $2.19 billion in 2024 [1] Group 1 - The drug BAT2506 is a biosimilar to Simponi, which is developed by Johnson & Johnson [1] - The company has established collaborations with multiple firms to advance the commercialization of BAT2506 in various regions [1] - The drug's marketing authorization applications have been accepted by regulatory authorities in China (NMPA), the USA (FDA), Europe (EMA), and Brazil (ANVISA) [1]