悦康藥業(688658.SH):注射用鹽酸頭孢吡肟(0.5g、1.0g)通過仿製藥一致性評價
格隆匯3月9日丨悦康藥業(688658.SH)公佈,近日,悦康藥業集團股份有限公司收到國家藥品監督管理局核准簽發的關於注射用鹽酸頭孢吡肟(0.5g、1.0g)的《藥品補充申請批准通知書》(通知書編號:2022B00959、2022B00958),該藥品通過仿製藥質量和療效一致性評價。
鹽酸頭孢吡肟是百時美施貴寶公司(Bristol-Myers SquibbCompany)開發的第四代廣譜頭孢菌素類抗生素,於1995年在日本上市,隨後於1996年在美國、法國等其他國家和地區上市,於1998年引入中國,商品名為Maxipime®。公司於2005年首次獲得注射用鹽酸頭孢吡肟的藥品註冊批件。
頭孢吡肟為廣譜抗菌藥物,其作用機制是抑制細菌細胞壁合成而達到殺菌的作用。體外試驗表明頭孢吡肟對革蘭陽性和陰性菌均有作用。注射用頭孢吡肟可用於治療成人和2月齡至16歲兒童敏感細菌引起的中重度感染,包括下呼吸道感染(肺炎和支氣管炎)、單純性和複雜性尿路感染(包括腎盂腎炎)、非複雜性皮膚和皮膚軟組織感染、複雜性腹腔內感染(包括腹膜炎和膽道感染)、婦產科感染、敗血症、以及中性粒細胞減少伴發熱患者的經驗治療,也可作為腹腔手術患者的預防性用藥,以及用於兒童細菌性腦脊髓膜炎。
經米內網查詢,2020年中國(城市公立)樣本醫院年度銷售趨勢顯示注射用鹽酸頭孢吡肟銷售額為2.452億元。
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