百奥泰：BAT2506（戈利木单抗）注射液上市许可申请获得美国FDA受理

格隆汇资讯2025-07-16

格隆汇7月16日丨百奥泰(688177.SH)公布，公司于近日收到BAT2506(戈利木单抗)注射液生物制品许可申请(BLA)获得美国食品药品监督管理局(称“美国FDA”)受理的通知。BAT2506(戈利木单抗)注射液是百奥泰根据中国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-...

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