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華北製藥(600812.SH):收到藥品註冊批件 涉及注射用頭孢唑肟鈉
格隆匯 11-18 18:48

格隆匯11月18日丨華北製藥(600812.SH)公佈,公司下屬子公司華北製藥河北華民藥業有限責任公司(“華民公司”)收到國家藥督管理核准簽發注射用頭孢唑肟鈉藥品註冊批件》。

注射用頭孢唑肟鈉是日本藤澤藥業工業株式會社(現更名為安斯泰來製藥株式會社)開發的第三代廣譜半合成頭孢菌素類抗生素,80年代初在日本上市,並於1983年在美國上市,商品名為“Epocelin”。本品屬於第三代頭孢菌素,具有廣譜抗菌作用。通過抑制細菌細胞壁粘肽的生物合成而達到殺菌作用。

該藥品首次提交註冊申請獲得受理的時間:201342日。

臨牀適應症:敏感菌所致的下呼吸道感染、尿路感染、腹腔感染、盆腔感染、敗血症、皮膚軟組織感染、骨和關節感染、肺炎鏈球菌或流感嗜血桿菌所致腦膜炎和單純性淋病。

截至目前,華民公司關於該藥品累計研發費用共計340萬元

目前國內已批准注射劑生產廠家36家,批准文號90個,均為注射用粉末,主要有0.5g0.75g1.0g三個規格。

此次華民公司獲得注射用頭孢唑肟鈉藥品註冊批件是對孢類產品及產品規格進一步補充,豐富了公司產品線製劑產品銷售業務易受到國內醫藥行業政策變動、招標採購、市場環境變化等因素影響,存在不確定性。

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