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白雲山(00874.HK):頭孢克肟膠囊已通過仿製藥質量和療效一致性評價
格隆匯 06-04 18:09

格隆匯6月4日丨白雲山(00874.HK)發佈公吿,2021年6月4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》,頭孢克肟膠囊已通過仿製藥質量和療效一致性評價。

白雲山製藥總廠頭孢克肟膠囊於1993年7月在國內正式上市,白雲山製藥總廠於2019年10月6日向國家藥品監督管理局遞交一致性評價申請,於2019年10月18日獲得受理。頭孢克肟為第三代頭孢菌素類抗生素,本品適用於對頭孢克肟敏感的鏈球菌屬(腸球菌除外),肺炎球菌、淋球菌、卡他布蘭漢球菌、大腸桿菌、克雷伯桿菌屬、沙雷菌屬、變形桿菌屬及流感桿菌等引起的下列細菌感染性疾病:1.支氣管炎、支氣管擴張症(感染時),慢性呼吸系統感染疾病的繼發感染,肺炎;2.腎盂腎炎、膀胱炎、淋球菌性尿道炎;3.膽囊炎、膽管炎;4.猩紅熱;5.中耳炎、副鼻竇炎。

目前國內頭孢克肟膠囊的生產廠家還包括石藥集團歐意藥業有限公司、金日製藥(中國)有限公司、齊魯製藥有限公司、成都倍特藥業股份有限公司、天津醫藥集團津康製藥有限公司等。根據米內網數據顯示,2020年頭孢克肟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50,649萬元和人民幣53,853萬元。

截至本公吿日,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786.61萬元(未審計)。2020年度白雲山製藥總廠該藥品的銷售收入為人民幣32,071.98萬元,約佔白雲山製藥總廠2020年度的營業收入的10.17%,約佔本公司2020年度的營業收入的0.52%。

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