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百奧泰(688177.SH):貝伐珠單抗注射液(BAT1706)上市許可申請獲得受理
格隆匯 06-19 19:23

格隆匯 6 月 19日丨百奧泰(688177.SH)公佈,公司近日收到國家藥品監督管理局(“國家藥監局)核准簽發的關於公司在研藥品貝伐珠單抗注射(BAT1706)上市許可申請的受理通知書》。

BAT1706是百奧泰根據中國NMPA、美國FDA歐盟EMA生物類似藥相關指導原則開發的貝伐珠單抗注射液,本次申報的適應症包括晚期、轉移性或復發性非小細胞肺癌和轉移性結直腸癌是一款靶向血管內皮生長因子(VEGF)人源化單克隆抗體可以特異性地與VEGF結合阻斷VEGF與其受體結合從而減少新生血管生成誘導現有血管的退化從而抑制腫瘤生長貝伐珠單抗原研藥在歐美獲批的適應症包括轉移性結直腸癌、晚期非鱗狀非小細胞肺癌、腎細胞癌、卵巢癌、宮頸癌、惡性膠質瘤等。

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