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亞寶藥業(600351.SH):子公司製劑產品索拉非尼片獲美FDA批准
格隆匯 11-14 16:01

格隆匯11月14日丨亞寶藥業(600351.SH)公佈,近日,公司全資子公司北京亞寶生物藥業有限公司(簡稱“亞寶生物公司”)收到美國食品藥品監督管理局(簡稱“美國FDA”)的通知,亞寶生物公司向美國FDA申報的索拉非尼片的新藥簡略申請(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。

索拉非尼屬於一種口服多靶點、多激酶抑制劑,主要用於不能手術的晚期腎細胞癌的治療,無法手術或遠處轉移的原發肝細胞癌的治療,局部晚期或轉移性放射性碘(RAI)難治性分化型甲狀腺癌的治療等。

索拉非尼片由Bayer公司開發,商品名Nexavar®,根據IQVIA統計,索拉非尼片2021年全球銷售額約5.36億美元,其中美國銷售額約6829萬美元,中國銷售額約8538萬美元。截至目前,公司在該產品研發項目上已投入研發費用約為2749.18萬元人民幣。

公司表示,此次亞寶生物公司索拉非尼片取得美國FDA的批准,標誌着亞寶生物公司已具備了在美國市場銷售上述產品的資格,有利於亞寶生物公司拓展美國市場,對公司的經營業績將產生積極影響。

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