白雲山(00874.HK):分公司諾氟沙星膠囊通過一致性評價
格隆匯12月27日丨白雲山(00874.HK)公佈,2021年12月24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”)收到國家藥監局簽發的《藥品補充申請批准通知書》(通知書編號:2021B04719),諾氟沙星膠囊已通過仿製藥質量和療效一致性評價。
白雲山製藥總廠的諾氟沙星膠囊於1987年10月21日在國內正式上市,並於2020年5月22日向國家藥監局遞交一致性評價申請,於2020年6月1日獲得受理。
諾氟沙星為第三代喹諾酮類抗生素,具廣譜抗菌作用,尤其對需氧革蘭陰性桿菌的抗菌活性高,臨牀用於敏感菌所致的尿路感染、淋病、前列腺炎、腸道感染和傷寒及其他沙門菌感染。
目前中國境內上市的諾氟沙星膠囊的生產廠家還包括四川科倫藥業股份有限公司、石藥集團歐意藥業有限公司、雲南白藥集團股份有限公司等。根據米內網數據顯示,2020年諾氟沙星膠囊在中國公立醫院和城市零售藥店的銷售額分別為人民幣2872萬元和人民幣1.78億元。
截至該公吿日,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693.73萬元(未經審計)。該藥品系白雲山製藥總廠藥品生產儲備,未投入生產和銷售。
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