江蘇吳中(600200.SH):子公司注射用阿奇黴素通過仿製藥一致性評價
格隆匯11月22日丨江蘇吳中(600200.SH)公佈,近日,公司全資子公司江蘇吳中醫藥集團有限公司下屬分支機構江蘇吳中醫藥集團有限公司蘇州製藥廠(“蘇州製藥廠”)收到了國家藥品監督管理局核准簽發的關於“注射用阿奇黴素”的《藥品補充申請批准通知書》(通知書編號:2021B04126),該藥品通過仿製藥質量和療效一致性評價。
阿奇黴素屬於大環內酯類抗生素。該類藥物的抗菌譜和抗菌活性基本相似,對多數革蘭陽性菌、軍團菌屬、衣原體屬、支原體屬、厭氧菌等具有良好抗菌作用。阿奇黴素為15元環大環內酯類,即氮內酯類的第一個品種;其作用機制為與細菌核糖體的50S亞單位結合,抑制細菌蛋白質合成;其藥效學及藥動學特性均較沿用品種有所改進,不良反應減少;對流感嗜血桿菌、卡他莫拉菌、淋病奈瑟菌的體外抗菌作用是紅黴素的2~8倍,對支原體屬、衣原體屬的作用也有所增強;在胃酸中穩定性增加,生物利用度高,血藥濃度和組織內藥物濃度增高,消除半衰期延長,每日的給藥劑量及給藥次數減少,胃腸道反應及肝毒性等不良反應也明顯減輕,臨牀適應症有所擴大,為治療社區獲得性呼吸道感染的合適藥物。
經查詢,阿奇黴素2020年國內樣本醫院銷售額約為2.05億元,其中注射劑8559.10萬元(PDB數據庫)。該產品為公司受託加工產品,根據雙方於2017年11月簽署的合作協議書約定,後續公司將上市許可持有人變更為委託方,該項目研發投入約450萬元人民幣,由委託方支付。
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