亞寶藥業(600351.SH):亞寶生物的塞來昔布膠囊獲得美國FDA批准
格隆匯4月12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申報的塞來昔布膠囊的新藥簡略申請(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。
塞來昔布膠囊主要適用於緩解骨關節炎、成人類風濕關節炎和強直性脊柱炎的症狀和體徵,以及治療成人急性疼痛。原研廠家為輝瑞(Pfizer)公司,於1998年以商品名“Celebrex®”獲美國FDA批准上市,於2000年8月以商品名“西樂葆”在中國批准進口。根據IQVIA統計,塞來昔布膠囊2022年前三季度全球銷售額約52,447.88萬美元,其中美國銷售額約7,889.37萬美元,中國銷售額約4517.06萬美元。
截至目前,公司在該產品研發項目上已投入研發費用約為1876.94萬元人民幣。
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