哈藥股份(600664.SH):哈藥總廠阿莫西林膠囊兩個規格通過一致性評價
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製藥總廠(以下簡稱“哈藥總廠”)收到國家藥品監督管理局頒發的關於阿莫西林膠囊兩個規格的《藥品補充申請批件》,該兩個規格藥品通過仿製藥質量和療效一致性評價。
阿莫西林膠囊是常用的口服β-內酰胺類抗感染藥物,用於治療細菌引起的不同部位感染(成人及兒童),如溶血鏈球菌、肺炎鏈球菌、葡萄球菌或流感嗜血桿菌所致中耳炎、鼻竇炎、咽炎、扁桃體炎等上呼吸道感染;大腸埃希菌、奇異變形桿菌或糞腸球菌所致的泌尿生殖感染;溶血鏈球菌、葡萄球菌或大腸埃希菌所致的皮膚軟組織感染;溶血鏈球菌、肺炎鏈球菌、葡萄球菌或流感嗜血桿菌所致急性支氣管炎、肺炎等下呼吸道感染。原研廠家為葛蘭素史克公司,於1972年在英國上市。截至本公告日,哈藥總廠針對該藥品兩個規格仿製藥質量和療效一致性評價已投入研發費用約1669萬元人民幣。
目前國內共有3個規格239個阿莫西林膠囊生產批文,中國境內主要生產廠家有石藥集團中諾藥業有限公司、珠海聯邦制藥股份有限公司、浙江金華康恩貝生物製藥有限公司等。截至本公告日,共有14個廠家阿莫西林膠囊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:阿莫西林口服制劑零售和醫療終端的市場銷售額為26.8億元,其中膠囊劑銷售額為21.4億元。2019年,哈藥總廠阿莫西林膠囊的銷售額為1.97億元。
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