石藥(01093.HK)新藥獲FDA頒發罕見兒童疾病資格認定
石藥集團(01093.HK)公布,附屬自主研發的在研產品人源化connexin43(Cx43)單克隆抗體(ALMB-0168)獲得美國食品藥品監督管理局(FDA)頒發針對治療骨癌的罕見兒童疾病資格認定,計劃於今年第四季提交該在研藥物的臨床試驗申請。
公告指目前骨癌的治療藥物和療法十分有限,主要採用常規化療和截肢手術等,屬於未被滿足的臨床需求。ALMB-0168為一款同類首創(First-in-Class)針對半通道膜蛋白Cx43的人源化單克隆抗體激動劑。臨床前體外和體內的動物實驗顯示ALMB-0168能有效通過激活Cx43蛋白釋放抑癌性物質而起到治療骨癌和癌症骨轉移的作用。
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