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海思科(002653.SZ):複方氨基酸注射液(18AA-Ⅶ)通過仿製藥一致性評價
格隆匯 06-13 16:38

格隆匯6月13日丨海思科(002653.SZ)公佈,公司的全資孫公司瀋陽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《藥品補充申請批准通知書》。

複方氨基酸注射液(18AA-Ⅶ)原研產品由森下製藥於1983年開始研發,1988年以“アミニック®輸液(日文)/AMINIC®(英文)”為商品名在日本批准上市。2002年6月由三菱製藥(廣州)有限公司在國內上市,曾用名“複方氨基酸注射液(18AA-B)”,商品名稱“綠支安”,規格:200ml:20.650g(總氨基酸)。

複方氨基酸注射液(18AA-Ⅶ)主要用於低蛋白血癥、低營養狀態和手術前後的氨基酸補充。複方氨基酸注射液(18AA-Ⅶ)含18種氨基酸,是必需氨基酸和非必需氨基酸的複方製劑,必需氨基酸/非必需氨基酸量比為1.7,支鏈氨基酸量比率35.9%。支鏈氨基酸是維持人體代謝的必需氨基酸,其不僅用於蛋白質的合成,在創傷、飢餓等應激狀態下還是機體重要的能量來源。該品為第四代氨基酸輸液產品,最適用於創傷、感染等應激狀態。

公司複方氨基酸注射液(18AA-Ⅶ)200ml規格於2010年6月取得國家藥品監督管理局頒發的《藥品註冊批件》,並於2021年7月通過仿製藥一致性評價。根據該產品的臨牀使用情況,公司在2015年申報增加該產品的400ml規格,並於2017年1月獲批上市。本次為該產品繼200ml規格通過仿製藥一致性評價後獲批的另一規格。

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