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李氏大藥廠(00950.HK):重組安菲博肽注射液或獲得臨牀試驗藥物申請受理通知書
格隆匯 10-14 21:50

格隆匯10月14日丨李氏大藥廠(00950.HK)公吿,於2024年9月25日,中國國家藥品監督管理局("國家藥監局")受理重組安菲博肽注射液臨牀試驗申請,受理號CXSL2400638、CXSL2400639。本次為該品首次臨牀試驗註冊申報,提交臨牀方案包括I期(單次給藥和多次給藥)以及II期臨牀方案。

重組安菲博肽注射液為一種由集團全資附屬公司兆科藥業(合肥)有限公司發現及擁有的一類治療用生物製品,符合中國國家藥監局發佈的藥品生產品質管制規範。

重組安菲博肽是在尖吻蝮蛇蛇毒天然蛋白Agkisacutacin(抗血小板溶栓素)序列基礎上進行優化,以CHO細胞為宿主細胞進行重組表達的蛋白,作用於血小板膜糖蛋白GPIb。該藥物為全新結構、全新靶點創新藥物。試驗表明該藥物是一個有效的GPIb抑制劑,通過與GP1bα結合,抑制GP1b-vWF相互作用,該靶點對抑制血栓的形成、預防心肌梗塞及血栓性血小板低下紫斑症均有作用。本集團擁有該藥物全球知識產權。

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