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眾生藥業(002317.SZ):頭孢克肟分散片通過仿製藥質量和療效一致性評價
格隆匯 07-08 19:08

格隆匯7月8日丨眾生藥業(002317.SZ)公佈,近日,公司收到國家藥品監督管理局批准簽發的《藥品補充申請批准通知書》,通知書編號:2021B01985、2021B01986。公司為國內通過頭孢克肟分散片仿製藥質量和療效一致性評價的前三家企業。

國內上市的頭孢克肟分散片適應症為對鏈球菌屬(腸球菌除外),肺炎球菌、淋球菌、卡他布蘭漢球菌、大腸桿菌、克雷伯桿菌屬、沙雷菌屬、變形桿菌屬,流感桿菌中頭孢克肟敏感菌引起的以下感染有效:1、慢性支氣管炎急性發作、急性支氣管炎併發細菌感染、支氣管擴張合併感染、肺炎;2、腎盂腎炎、膀胱炎、淋球菌性尿道炎;3、急性膽道系統細菌性感染(膽囊炎、膽管炎);4、猩紅熱;5、中耳炎、鼻竇炎。

頭孢克肟是第三代頭孢菌素類藥物,其抗菌譜廣,藥效較好,通過破壞細菌細胞壁阻止細菌繁殖。其對於因敏感菌所致的呼吸系統感染具有顯著治療效果,且有研究發現,該藥物對各種細菌所產生的β-內酰胺酶具有較強穩定性,在支氣管肺炎治療中,被廣泛運用。

頭孢克肟分散片為國家醫保目錄藥品。米內網中國城市公立醫院化學藥終端競爭格局數據庫顯示,頭孢克肟2018至2020年銷售額分別為人民幣38.975億元,39.929億元,30.494億元。

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