石藥集團(01093.HK)同類首創在研產品ALMB-0168獲美國FDA頒發孤兒藥資格認定
格隆匯9月23日丨石藥集團(01093.HK)發佈公告,集團附屬公司AlaMab Therapeutics, Inc.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)頒發就治療骨癌(Osteosarcoma)的孤兒藥資格認定。
骨癌是發生於人體長骨組織中的一種惡性腫瘤,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connexin 43(Cx43)的人源化單克隆激抗體激動劑。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。
此孤兒藥資格認定將使集團可與美國藥監局頻繁溝通,並加快ALMB-0168的臨牀開發、註冊及上市速度。集團計劃於2019年第四季度提交該在研藥物的臨牀試驗申請。
AlaMab Therapeutics, Inc.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。該公司針對同一靶點的另一款處於臨牀階段的抑制型單克隆抗體(ALMB-0166)已於2018 年11月獲得FDA頒發就治療急性脊髓損傷的孤兒藥資格認定。
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