聯邦制藥(03933.HK):集團產品注射用阿莫西林鈉克拉維酸鉀通過一致性評價
格隆匯7月17日丨聯邦制藥(03933.HK)公吿,公司全資附屬公司珠海聯邦制藥股份有限公司中山分公司申報的注射用阿莫西林鈉克拉維酸鉀(規格:0.6g、1.2g)經中國國家藥品監督管理局審批,通過仿製藥質量和療效一致性評價("一致性評價")。
注射用阿莫西林鈉克拉維酸鉀是一種青黴素類廣譜抗生素,由阿莫西林鈉(青黴素類抗生素)與克拉維酸鉀(β-內酰胺酶抑制劑)組成。克拉維酸通過抑制細菌產生的β-內酰胺酶,顯著增強阿莫西林對耐藥菌的抗菌活性。臨牀適用於治療由敏感菌引起的上呼吸道感染、下呼吸道感染、生殖泌尿道感染、皮膚及軟組織感染、骨和關節感染等。現時,注射用阿莫西林鈉克拉維酸鉀為國家基藥目錄(2018年版)及國家醫保目錄(2024年版)乙類藥品。
本次獲批將進一步有助於公司鞏固於抗感染領域的優勢地位。公司將持續致力於新產品研發及推進一致性評價,預期將為公司及其股東創造更大收益。
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