石藥集團(01093.HK)同類首創在研產品ALMB-0168 獲美國FDA頒發罕見兒童疾病資格認定
格隆匯10月18日丨石藥集團(01093.HK)發佈公告,公司附屬公司AlaMab Therapeutics Inc(. “AlaMab”)自主研發的在研產品人源化connexin 43(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 (Osteosarcoma)的罕見兒童疾病資格認定。這是繼ALMB-0168於2019年9月獲得美國FDA 頒發孤兒藥資格認定後的另一個資格認定。
骨癌是發生於人體長骨組織中的一種惡性腫瘤,多發生於兒童和青少年,一般造成截肢或死亡等嚴重後果。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,屬於未被滿足的臨牀需求。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。臨牀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。
根據美國FDA罕見兒童疾病資格認定計劃,ALMB-0168針對兒童骨癌適應症的上市申請會獲得優先審評,而當ALMB-0168針對兒童骨癌適應症的上市申請獲得批准,美國FDA 會向AlaMab頒發一張可用於另外一款產品上市申請的可轉讓優先審評劵(Priority Review Voucher)。AlaMab計劃於2019年第四季度提交該在研藥物的臨牀試驗申請。
AlaMab為一家位於美國致力於同類首創抗體藥物開發的創新生物醫藥公司,其另一個針對同一靶點的在研產品ALMB-0166亦已於2018年11月獲得美國FDA頒發就治療急性脊髓損傷的孤兒藥資格認定。
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