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海正藥業(600267.SH):海正杭州公司製劑產品克拉屈濱注射液獲美國FDA批准
格隆匯 11-27 17:56

格隆匯11月27日丨海正藥業(600267.SH)公佈,近日,公司全資子公司海正藥業(杭州)有限公司(以下簡稱“海正杭州公司”)收到美國食品藥品監督管理局(以下簡稱“美國FDA”)的通知,海正杭州公司向美國FDA申報的克拉屈濱注射液的新藥簡略申請(ANDA,即美國仿製藥申請,申請獲得美國FDA審評批准意味着申請者可以生產並在美國市場銷售該產品)已獲得批准。

克拉屈濱注射液適用於治療臨牀上表現為貧血,中性粒細胞減少,血小板減少等症狀的毛細胞白血病。原研藥Leustatin Injection,1mg/mL由Janssen Pharmaceuticals Inc.公司研發,國內外生產、銷售廠商主要有WEST-WARD PHARMSINT、MYLANLABS LTD、FRESENIUS KABI USA、浙江海正藥業股份有限公司等。據統計,克拉屈濱注射液2018年全球銷售額約1535.45萬美元,其中美國市場銷售額約499.37萬美元;2019年1-6月全球銷售額約770.22萬美元,其中美國市場銷售額約229.56萬美元(數據來源於IMS)。截至目前,公司在克拉屈濱注射液研發項目上已投入約320.53萬元人民幣。

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