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華東醫藥(000963.SZ)全資子公司藥品注射用達託黴素獲得美國FDA批准
格隆匯 11-28 17:09

格隆匯11月28日丨華東醫藥(000963.SZ)公吿,近日,華東醫藥股份有限公司(以下簡稱“公司”)全資子公司杭州中美華東製藥有限公司(以下簡稱“中美華東”)收到美國食品藥品監督管理局(以下簡稱“美國FDA”)的通知,中美華東向美國FDA申報的注射用達託黴素的新藥簡略申請(ANDA)已獲得批准。

 達託黴素(Daptomycin)屬於環脂肽類抗生素,是一種超級抗生素產品,用於治療複雜性皮膚及軟組織感染(cSSSI)、金黃色葡萄球菌血流感染(菌血症)以及伴發的右側感染性心內膜炎。達託黴素與細菌細胞膜結合,並引起細胞膜電位的快速去極化。細胞膜電位的這種缺失抑制DNA、RNA和蛋白質的合成,最終導致細菌細胞死亡。 

中美華東研發的注射用達託黴素於2015年11月在國內獲批上市,於2021年11月通過質量和療效一致性評價。本次注射用達託黴素美國ANDA申請於2020年9月遞交,於2021年11月獲得美國FDA批准,是公司繼注射用泮托拉唑鈉後又一獲批的凍乾粉針製劑,亦是國內為數不多同時擁有中國、美國上市許可的達託黴素製劑產品。

這是公司持續強化產品研發、提高產品質量標準,積極推進製劑國際化工作取得的重要成果,也將為該產品今後拓展海外市場帶來積極影響。公司計劃於明年積極推動注射用達託黴素在美國的上市銷售工作。

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