百奧泰(688177.SH):BAT2506(戈利木單抗)注射液上市許可申請獲得美國FDA受理
格隆匯7月16日丨百奧泰(688177.SH)公佈,公司於近日收到BAT2506(戈利木單抗)注射液生物製品許可申請(BLA)獲得美國食品藥品監督管理局(稱“美國FDA”)受理的通知。
BAT2506(戈利木單抗)注射液是百奧泰根據中國NMPA、美國FDA、歐洲EMA生物類似藥相關指導原則開發的戈利木單抗生物類似藥。戈利木單抗是靶向TNF-α的抗體,能夠以高親和力特異性地結合可溶性及跨膜的人TNF-α,阻斷TNF-α與其受體TNFR結合,從而抑制TNF-α的活性。
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