白雲山(00874.HK)枸櫞酸西地那非片通過仿製藥一致性評價
格隆匯1月20日丨白雲山(00874.HK)發佈公告,今日,公司分公司廣州白雲山醫藥集團股份有限公司白雲山製藥總廠通過國家藥品監督管理局藥品評審中心(“CDE”)網站獲悉,枸櫞酸西地那非片已通過仿製藥質量和療效一致性評價。
枸櫞酸西地那非片於2014年10月在國內正式上市,並於2018年8月30日向國家藥品監督管理局遞交一致性評價申請,於2018年9月6日獲得受理。枸櫞酸西地那非片適應症為勃起功能障礙,是一種5型磷酸二酯酶(PDE5)選擇性抑制劑。
白雲山製藥總廠成為該品種國內首家通過一致性評價的企業。目前中國境內上市的枸櫞酸西地那非片的生產廠家還包括輝瑞製藥有限公司、江蘇亞邦愛普森藥業有限公司、成都地奧製藥集團有限公司、常山生化藥業(江蘇)有限公司、吉林金恆製藥股份有限公司等。根據米內網數據顯示,2018年枸櫞酸西地那非片在中國公立醫院和城市零售藥店的銷售額分別為人民幣11,445萬元和人民幣220,690萬元。
截至公告日,白雲山製藥總廠針對該藥品一致性評價已投入研發費用約人民幣2,006.17萬元(未經審計)。2018年度白雲山製藥總廠該藥品的銷售收入為人民幣66,205.78萬元,約佔白雲山製藥總廠2018年度的營業收入的19.97%,約佔公司2018年度的營業收入的1.57%。
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