百奧泰(688177.SH):重組抗VEGF人源化單克隆抗體注射液獲臨牀試驗通知書
格隆匯3月2日丨百奧泰(688177.SH)公佈,公司於2020年3月2日收到國家藥品監督管理局(以下簡稱“國家藥監局”)核准簽發的關於公司在研藥品BAT5906新增糖尿病性黃斑水腫(DME)適應症的《臨牀試驗通知書》。
BAT5906(重組抗VEGF人源化單克隆抗體注射液)是公司專門設計用於眼底病變治療的單克隆抗體。2019年11月公司向國家藥監局遞交新增糖尿病性黃斑水腫(DME)適應症的II期臨牀申請,並於2020年3月2日收到國家藥品監督管理局核准簽發的《臨牀試驗通知書》。
在眼底病變疾病治療領域,國內已有雷珠單抗、阿柏西普、康柏西普3個抗VEGF藥物獲批上市,儘管BAT5906是新一代抗體藥物,但鑑於患者的依從性,已上市競品和其他潛在競品可能會擁有先行者優勢,BAT5906可能在未來面臨激烈的市場競爭。
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