石藥集團(01093.HK):在研新藥NBL-015獲美國藥監局頒發孤兒藥資格認定
格隆匯 4 月 9日丨石藥集團(01093.HK)發佈公吿,公司附屬公司美國NovaRock Biotherapeutics Limited(“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。這是NBL-015繼2020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。
根據披露,胃癌是起源於胃黏膜上皮的惡性腫瘤,在美國屬於罕見病。據世界衞生組織2020年數據,胃癌在全球癌症致死率排名第三,並居全球女性第七高發癌症,男性第四高發癌症。胃癌在東亞地區發病風險最高,在中國居各種惡性腫瘤中發病率第二位。
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的臨牀開發、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牀試驗申請。
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