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百奧泰(688177.SH):BAT1806(託珠單抗)注射液在美國FDA上市許可申請獲得受理
格隆匯 12-09 20:56

格隆匯12月9日丨百奧泰(688177.SH)公佈,公司向美國食品藥品監督管理局(Food and Drug Administration 以下簡稱“美國FDA”)遞交了BAT1806(託珠單抗)注射液的生物製品上市申請,並於近期收到了美國FDA受理的通知。

BAT1806是百奧泰根據國家藥品監督管理局、美國FDA、歐洲EMA生物類似藥相關指導原則開發的託珠單抗注射液,是一款靶向白介素-6受體(IL-6R)的重組人源化單克隆抗體,可與可溶性和膜結合型IL-6受體(sIL-6R和mIL-6R)特異性結合,並抑制由sIL-6R或mIL-6R介導的信號傳導。

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