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石藥(01093.HK)胃癌新藥獲美國FDA孤兒藥資格認定
阿思達克 04-09 16:42
石藥集團(01093.HK)公布,公司附屬美國NovaRock自主研發的抗體藥物NBL-015,獲得美國食品藥品監督管理局(FDA)頒發針對治療胃癌包括食道胃結合部癌的孤兒藥資格認定,為NBL-015繼去年12月獲得針對胰腺癌孤兒藥資格認定後,獲得的第二項孤兒藥資格認定。

集團指,孤兒藥資格認定將使集團可與美國FDA密切溝通,並加快NBL-015的臨床開發、註冊及上市速度。NovaRock計劃將於近期提交該在研新藥於中國及美國的臨床試驗申請。

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