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白雲山(00874.HK):鹽酸環丙沙星片通過仿製藥質量和療效一致性評價
格隆匯 04-22 17:37

格隆匯4月22日丨白雲山(00874.HK)公佈,2020年4月22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("白雲山製藥總廠")收到國家藥品監督管理局簽發的《藥品補充申請批件》(批件號:2020B02866),鹽酸環丙沙星片已通過仿製藥質量和療效一致性評價。

鹽酸環丙沙星片是合成的第三代喹諾酮類抗菌藥物,用於敏感菌所致的泌尿生殖系統、呼吸道、胃腸道、皮膚軟組織等感染。

目前中國境內上市的鹽酸環丙沙星片的生產廠家還包括浙江京新藥業股份有限公司、廣東華南藥業集團有限公司、萊陽市江波製藥有限責任公司、哈藥集團製藥六廠、重慶科瑞製藥(集團)有限公司等。根據米內網數據顯示,2018年鹽酸環丙沙星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414萬元和人民幣479萬元。

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461.24萬元(未經審計)。2019年度該藥品無生產和銷售。

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