白雲山(00874.HK):頭孢氨苄膠囊已通過仿製藥質量和療效一致性評價
格隆匯 12 月 9日丨白雲山(00874.HK)公告,2020年12月8日,廣州白雲山醫藥集團股份有限公司(“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《藥品補充申請批准通知書》(通知書編號:2020B05142),頭孢氨苄膠囊已通過仿製藥質量和療效一致性評價。現將有關情況公告如下:
頭孢氨苄膠囊是第一代頭孢菌素,用於敏感菌所致的急性扁桃體炎、咽峽炎、2中耳炎、鼻竇炎、支氣管炎、肺炎等呼吸道感染、尿路感染及皮膚軟組織感染等。
白雲山製藥總廠頭孢氨苄膠囊於1990年4月在國內正式上市,並於2019年7月1日向國家藥品監督管理局遞交一致性評價申請,於2019年7月8日獲得受理。
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723萬元(未經審計)。目前國內頭孢氨苄膠囊的生產廠家還包括上海現代製藥股份有限公司、石藥集團歐意藥業有限公司、華北製藥河北華民藥業有限責任公司、山東羅欣藥業集團股份有限公司等。
根據米內網數據顯示,2019年頭孢氨苄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3,506萬元和人民幣1,831萬元。
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