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君實生物(688180.SH):君實工程特瑞普利單抗注射液通過藥品GMP符合性檢查

格隆匯3月9日丨君實生物(688180.SH)公佈,近日,上海君實生物醫藥科技股份有限公司全資子公司上海君實生物工程有限公司(簡稱“君實工程”)收到上海市藥品監督管理局簽發的《藥品生產現場檢查結果吿知書》,君實工程位於上海臨港的生產基地(簡稱“上海臨港生產基地”)生產的特瑞普利單抗注射液(商品名:拓益®,產品代號:JS001)已通過上海市藥品監督管理局組織開展的藥品生產質量管理規範符合性檢查,結果符合《藥品生產質量管理規範》要求。

此次君實工程通過藥品GMP符合性檢查,標誌着上海臨港生產基地已完全具備正式生產商業化批次的特瑞普利單抗注射液的條件。上海臨港生產基地按照CGMP標準建設,其中一期項目產能30,000升。由於規模效應,上海臨港生產基地帶來的產能擴充將使公司獲得更具競爭力的生產成本。

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