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百奧泰(688177.SH):重組抗VEGF人源化單克隆抗體注射液獲得藥物臨牀試驗批準通知書

格隆匯8月1日丨百奧泰(688177.SH)公佈,近日收到國家藥品監督管理局覈準簽發的關於公司在研藥品重組抗VEGF人源化單克隆抗體注射液(BAT5906)新增視網膜中央靜脈阻塞所致黃斑水腫(CRVO-ME)和病理性近視的脈絡膜新生血管(pmCNV)的《藥物臨牀試驗批準通知書》。

BAT5906是百奧泰自主研發生產的重組人源化單克隆抗體創新藥物,爲IgG1型全長抗體,分子量爲149KDa,能與人VEGF-A165進行特異性結合,抑制新生血管生成。在體外血管生成模型上,BAT5906能夠阻斷VEGF與其相應的受體結合,抑制內皮細胞的增殖和新生血管形成。在動物實驗中,BAT5906的血清半衰期比結構爲Fab片段的雷珠單抗更長,可能會支持臨牀中更長的注射週期。在用藥安全性上,不會觸發抗體依賴的細胞介導的細胞毒性作用(ADCC),因而全身不良反應小,臨牀應用可能更安全。

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