百奧泰(688177.SH):貝伐珠單抗注射液(BAT1706)在美國FDA上市許可申請獲受理
格隆匯1月27日丨百奧泰(688177.SH)公佈,公司於2020年第四季度向美國食品藥品監督管理局(Food and Drug Administration“美國FDA”)遞交了BAT1706(貝伐珠單抗)注射液的生物製品上市申請(BLA),並於近日收到了美國FDA受理的通知。
BAT1706是百奧泰根據中國國家藥品監督管理局(NMPA)、美國FDA和歐洲藥品管理局(EMA)生物類似藥相關指導原則開發的貝伐珠單抗注射液,通過與血管內皮生長因子(VEGF)結合而起效。貝伐珠單抗原研藥在美國獲批的適應症包括轉移性結直腸癌、非鱗狀非小細胞肺癌、複發性膠質母細胞瘤、轉移性腎細胞癌、持續性、複發性或轉移性宮頸癌、上皮性卵巢癌、輸卵管癌或原發性腹膜癌、以及肝細胞癌。
截至本公吿發布日,公司已向中國NMPA、美國FDA以及歐洲EMA遞交了BAT1706的上市許可申請。
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