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普洛藥業(000739.SZ):子公司頭孢克肟顆粒獲批上市
格隆匯 09-28 17:07

格隆匯9月28日丨普洛藥業(000739.SZ)公佈,近日,公司全資子公司浙江巨泰藥業有限公司收到國家藥監局核准簽發的關於頭孢克肟顆粒的《藥品註冊證書》。

本品為口服第三代頭孢菌素,抗菌譜廣,對部分革蘭氏陽性菌及陰性菌均具有抗菌活性,特別是對革蘭氏陽性菌中的鏈球菌(腸球菌除外)、肺炎球菌,革蘭氏陰性菌中的淋球菌、布蘭漢氏球菌、大腸菌、克雷伯氏屬、沙雷氏屬、變形桿菌屬、流行桿菌等有較強的抗菌作用。頭孢克肟顆粒屬於乙類國家醫保目錄產品。根據米內網數據顯示,頭孢克肟口服制劑2019年和2020年在國內的銷售額分別約為36.12億元和27.32億元。

截止目前,公司用於開展頭孢克肟顆粒項目累計投入研發費用約852.68萬元。

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,本藥品視同通過仿製藥質量和療效一致性評價。截止目前,公司為國內第五家通過頭孢克肟顆粒一致性評價的企業,該產品是公司現有產業基礎的延伸,有利於實現公司原料藥製劑一體化戰略。該註冊證書的獲得標誌着公司取得了參加該產品後續集採的資格,可以進一步提升該產品的市場競爭力,對公司經營發展具有一定的積極作用。

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