衞信康(603676.SH)：子公司獲得多種微量元素注射液藥品註冊批件
格隆匯3月19日丨衞信康(603676.SH)公佈，近日，公司全資子公司內蒙古白醫製藥股份有限公司收到國家藥品監督管理局核准簽發的多種微量元素注射液《藥品註冊批件》。
2013年11月內蒙古白醫製藥股份有限公司以藥品名稱混合微量元素注射液(10)向內蒙古自治區食品藥品監督管理局提交藥品註冊申請並獲受理，同時關聯申報了相關原輔料：葡萄糖酸內酯、葡萄糖酸錳、葡萄糖酸銅、葡萄糖酸鈷、氯化鉻、七鉬酸銨、碘化鈉、氟化鈉，目前以上相關原輔料均已通過技術審評，備案狀態為：A。
多種微量元素注射液為微量元素補充劑，含有10種微量元素，適用於需腸外營養的成人患者。多種微量元素注射液原研產品為法國LABORATOIRE AGUETTANT公司的DECAN®，目前已在法國、英國、希臘、意大利、波蘭、奧地利、丹麥、西班牙、芬蘭、盧森堡、荷蘭、葡萄牙、瑞典、愛爾蘭共和國等多個國家上市銷售，已於2011年12月獲批向我國進口，商品名為“來維”，進口藥品註冊證號為H20110522。
經查詢，國內已批准的多種微量元素注射液生產廠家僅有法國LABORATOIRE AGUETTANT公司。經檢索，截至本公告披露日，國內未有其他廠家進行多種微量元素注射液的申報。而國內已有供成人補充微量元素的同類製劑多種微量元素注射液(II)生產廠家有：百正藥業股份有限公司、費森尤斯卡比華瑞製藥有限公司、吉林四長製藥有限公司、四川美大康佳樂藥業有限公司。
多種微量元素注射液和多種微量元素注射液(II)均已被納入2019年國家醫保目錄(乙類)。
根據米內網數據統計，2018年多種微量元素注射液在我國城市、縣級、社區及鄉鎮三大終端公立醫療機構銷售金額約為2.32億元，2018年多種微量元素注射液(II)在我國城市、縣級、社區及鄉鎮三大終端公立醫療機構銷售金額約為5.67億元。
截至目前，多種微量元素注射液項目已投入研發費用約2571.03萬元人民幣。
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