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普洛藥業(000739.SZ):鹽酸美金剛片獲批上市
格隆匯 02-08 15:57

格隆匯 2 月 8日丨普洛藥業(000739.SZ)公佈,近日,公司收到國家藥品監督管理局核准簽發的《藥品註冊批件》。

藥品名稱:鹽酸美金剛片;劑型:片劑;規格:10mg;申請事項:藥品註冊(境內生產);註冊分類:化學藥品4類;藥品註冊標準編號:YBH15752020;藥品批准文號:國藥準字H20213080;藥品生產企業:浙江普洛康裕製藥有限公司;藥品上市許可持有人:普洛藥業股份有限公司;審批結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,本品符合藥品註冊的有關要求,批准註冊,發給藥品註冊證書。

鹽酸美金剛片是用於治療中重度阿爾茨海默症的藥物,屬於2020年版國家醫保乙類藥物。

根據米內網數據顯示,在國內城市公立、縣級公立和鄉鎮衞生終端數據中,2019年銷售金額為5.34億元,同比增長15.83%,其中原研廠家丹麥靈北該品種銷售金額為4.5億元,同比增長9.32%。零售終端2019年銷售金額6692萬元,同比增長14.00%,其中原研廠家丹麥靈北該品種銷售金額為6,135萬元,同比增長7.88%。

公司於2019年3月向國家藥監局提交了項目註冊申請。截止目前,公司用於開展鹽酸美金片項目累計投入研發費用約398萬元。

根據國家藥監局《關於仿製藥質量和療效一致性評價工作有關事項的公吿》(2017年第100號)文件相關規定,該藥品視為通過仿製藥質量和療效一致性評價。公司鹽酸美金剛片註冊批件的取得,進一步豐富了公司的製劑產品線,是公司現有產業鏈基礎的延伸,有利於公司實現原料藥製劑一體化戰略,也有助於公司在神經系統領域的進一步發展,對公司經營發展也具有一定的積極作用。

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