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白雲山(00874.HK)分公司頭孢克肟顆粒通過仿製藥一致性評價
格隆匯 03-03 18:26

格隆匯3月3日丨白雲山(00874.HK)發佈公告,2020年3月3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《藥品補充申請批件》,頭孢克肟顆粒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顆粒於1994年4月在國內正式上市,並於2018年11月5日向國家藥品監督管理局遞交一致性評價申請,於2018年11月12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。

目前國內頭孢克肟顆粒的生產廠家還包括國藥集團致君(深圳)製藥有限公司、成都倍特藥業股份有限公司、廣東恆健製藥有限公司、康普藥業股份有限公司、金陵藥業股份有限公司南京金陵製藥廠等。根據米內網數據顯示,2018年頭孢克肟顆粒在中國公立醫院和城市零售藥店的銷售額分別為人民幣5.9億元和人民幣2.38億元。

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603.86萬元(未審計)。2018年度白雲山製藥總廠該藥品的銷售收入為人民幣2.99億元,約佔白雲山製藥總廠2018年度的營業收入的9.03%,約佔本公司2018年度的營業收入的0.71%。

公司稱,白雲山製藥總廠的頭孢克肟顆粒通過仿製藥一致性評價,有利於提升該藥品的市場競爭力。

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