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百濟神州(06160.HK)胰腺癌進口藥上市申請獲受理
阿思達克 06-04 07:26

百濟神州(06160.HK)公布,國家藥監局已受理ABRAXANE注射用紫杉醇(納米蛋白顆粒結合型)聯合吉西他濱,用於治療一線轉移性胰腺癌患者的進口藥品新適應症上市申請。

ABRAXANE於2008年在內地首次獲批用於治療轉移性乳腺癌患者。公司獲得新基公司授予的ABRAXANE獨家經銷,可在內地獨家銷售該藥品。

此外,國家藥監局也已受理了一項在研抗PD-1抗體替雷利珠單抗用於治療先前接受過治療的局部晚期或轉移性尿路上皮癌患者的新適應症上市申請。

替雷利珠單抗是第一款由百濟神州的免疫腫瘤生物平台研發的候選藥物,目前正作為單藥療法及聯合療法開發針對一系列實體瘤和血液腫瘤治療適應症。

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