普洛藥業(000739.SZ):注射用氟氯西林鈉獲批上市
格隆匯4月14日丨普洛藥業(000739.SZ)公佈,近日,公司之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注射用氟氯西林鈉的《藥品註冊證書》。
注射用氟氯西林鈉適用於治療敏感的革蘭氏陽性菌引起的皮膚及軟組織感染及呼吸道感染等,包括產β-內酰胺酶的葡萄球菌和鏈球菌。
據米內網數據顯示:氟氯西林2019年和2020年在國內城市公立醫院、縣級公立醫院及鄉鎮衞生院終端銷售金額分別為4.45億元和3.13億元。其中注射劑型在2019年和2020年銷售金額分別為4.36億元和3.04億元。
截止目前,公司用於開展注射用氟氯西林鈉項目累計投入研發費用約638萬元。截止目前,公司為國內該藥品首家以藥品註冊分類3類獲批的企業。
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)相關規定,該藥品視同通過仿製藥質量和療效一致性評價。該證書的獲得是公司原料藥製劑一體化戰略的重要體現,有利於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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