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華東醫藥(000963.SZ):阿卡波糖片獲得美國FDA批准文號
格隆匯 08-31 17:27

格隆匯 8 月 31日丨華東醫藥(000963.SZ)公佈,近日,公司收到美國食品藥品監督管理局(“美國FDA)的通知,公司全資子公司杭州中美華東製藥有限公司(中美華東)向美國FDA申報的阿卡波糖片口服固體制劑的新藥簡略申請(ANDA,即美國仿製藥申請)已獲得批准。

阿卡波糖是一種α-糖苷酶抑制劑,原研廠家為德國拜耳醫藥,1990年在德國上市,1994年在中國批准註冊上市,1995年獲得美國FDA批准並上市。阿卡波糖作為一種口服降血糖藥,在腸道內可以競爭性抑制葡萄糖苷水解酶,抑制澱粉類分解為葡萄糖,進而減少腸道內葡萄糖的吸收,從而緩解餐後高血糖,達到降低血糖的作用。

阿卡波糖片目前為中美華東糖尿病領域重要品種。根據IQVIA (艾昆緯)數據庫顯示:2019年阿卡波糖製劑產品全球銷售額為6.89億美元

公司高度重視產品研發及質量管理體系建設,通過FDA認證的產國內產品同一條生產線中美華東生產的阿卡波糖片於201811月國內首家通過仿製藥質量和療效一致性評價,於201912月獲得歐盟地區奧地利市場的上市許可此次阿卡波糖片申請於201910月提交,20208獲得美國FDA批准為國內阿卡波糖製劑產品第一家獲得美國FDA批准,也是國內首家同時擁有中國、美國和歐盟地區奧地利市場上市許可的阿卡波糖製劑產品表明公司的阿卡波糖片產品質量獲得國際認可,技術質量標準與國際主流市場相應標準一致,藥品生產質量管理體系逐漸與國際接軌,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公司後續產品通過國際註冊認證開拓國際市場奠定了良好基礎。

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