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哈藥股份(600664.SH):世一堂布洛芬顆粒通過一致性評價
格隆匯 04-22 18:25

格隆匯4月22日丨哈藥股份(600664.SH)公佈,近日,公司分公司哈藥集團世一堂製藥廠(以下簡稱“世一堂”)收到國家藥品監督管理局頒發的關於布洛芬顆粒的《藥品補充申請批件》,該藥品通過仿製藥質量和療效一致性評價。

布洛芬顆粒具有緩解輕至中度疼痛如頭痛、關節痛、偏頭痛、牙痛、肌肉痛、神經痛、痛經及普通感冒或流行性感冒引起的發熱的作用。原研廠家為日本科研株式會社,並於1971年11月在日本上市。布洛芬顆粒能抑制前列腺素的合成,具有鎮痛、解熱和抗炎的作用,屬解熱鎮痛類非處方藥藥品。截至本公告日,世一堂針對該藥品仿製藥質量和療效一致性評價已投入研發費用約1049萬元人民幣。

目前國內共有2個規格11個布洛芬顆粒劑生產批文,中國境內主要生產廠家有石藥集團歐意藥業有限公司、揚子江藥業集團及浙江康恩貝製藥股份有限公司等。截至本公告日,共有5個廠家2個規格布洛芬顆粒通過國家藥品監督管理局仿製藥質量和療效一致性評價審批。米內數據顯示:2018年布洛芬口服制劑零售和醫療終端的市場銷售額為26億元,其中顆粒劑銷售額為2億元。2019年,公司該藥品的銷售額為6347萬元。

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