白雲山(00874.HK):“鹽酸美金剛片”獲國家藥監局註冊批件
格隆匯9月24日丨白雲山(00874.HK)公告,廣州白雲山醫藥集團股份有限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於2019年9月24日收到國家藥品監督管理局核准簽發的鹽酸美金剛片《藥品註冊批件》(批件號:2019S00530)。
鹽酸美金剛片是用於治療中重度阿爾茨海默症的藥物,其作用機制為拮抗N-甲酰天冬氨酸受體,延緩興奮性神經遞質谷氨鹽酸的釋放,改善認知功能,屬於2019年版國家醫保乙類藥物。2016年10月19日,白雲山製藥總廠向國家食品藥品監督管理局遞交的藥品註冊申請獲受理。目前,公司成為該品種國內首家通過一致性評價的企業。經查詢,目前藥品鹽酸美金剛片的主要生產廠家為丹麥靈北製藥有限公司和珠海聯邦制藥股份有限公司。
根據米內網數據顯示,2018年靈北製藥和聯邦制藥在國內城市公立醫院、縣級公立醫院的銷售額分別為人民幣41,072萬元和人民幣4638萬元。
截至目前,白雲山製藥總廠在藥品鹽酸美金剛片研發項目上已投入研發費用合計約為人民幣575.67萬元。次獲得鹽酸美金剛片的《藥品註冊批件》,豐富了公司藥物產品的種類,有利於提升公司在神經退行性疾病領域市場的競爭力。目前,公司將按照相關要求和市場需求開展生產。
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