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海思科(002653.SZ):注射用鹽酸頭孢替安國內首家通過一致性評價
格隆匯 09-23 16:39

格隆匯9月23日丨海思科(002653.SZ)公佈,公司之全資子公司遼寧海思科製藥有限公司於近日收到國家藥品監督管理局下發的關於注射用鹽酸頭孢替安(0.5g、1.0g、2.0g)的《藥品補充申請批准通知書》。

鹽酸頭孢替安為第二代頭孢菌素類抗生素製劑,作用機制為其與細菌細胞膜上的青黴素結合蛋白(PBPs)結合,使轉肽酶酰化,影響細胞壁粘肽成分的交叉連結,使細胞分裂和生長受到抑制,細菌形態變長,最後溶解和死亡。本品適用於治療敏感菌所致的感染,如肺炎、支氣管炎、膽道感染、腹膜炎、尿路感染以及手術和外傷所致的感染和敗血症等。本品可用生理鹽水或者葡萄糖注射液溶解完全後,用於靜脈滴注或靜脈注射。

注射用鹽酸頭孢替安原研藥品於1980年10月首次在日本獲准上市,商品名為ハロスポア®/Halospor®,為富士フイルム富山化學株式會社公司生產。公司已於2021年9月通過注射用鹽酸頭孢替安一致性評價審批,產品質量、劑型、適應症等與原研藥品一致,為該品種國內首家通過化學藥品仿製藥質量和療效一致性評價的企業。

據米內網數據顯示,注射用鹽酸頭孢替安2020年在城市公立及縣級公立醫院銷售額約為12.5億元。

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