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華蘭生物(002007.SZ):“重組Exendin-4-Fc融合蛋白注射液”藥物獲批臨牀
格隆匯 09-17 18:45

格隆匯 9 月 17日丨華蘭生物(002007.SZ)公告,2020年9月17日,公司收到國家藥品監督管理局下發的“重組Exendin-4-Fc融合蛋白注射液”藥物臨牀試驗批准通知書,通知書編號為:2020LP00444。重組Exendin-4-Fc融合蛋白注射液的適應症為:II型糖尿病患者,輔助飲食和運動治療改善血糖控制。

按照藥品註冊程序,公司在取得上述藥物臨牀試驗批准通知書後,將按照國家藥物臨牀試驗的要求儘快組織實施臨牀試驗,待臨牀試驗結束後將申報產品生產批件和GMP認證。臨牀試驗的完成時間、進度及結果均具有一定的不確定性,公司將根據產品的後續進展情況及時履行信息披露義務。本次“重組Exendin-4-Fc融合蛋白注射液”取得藥物臨牀試驗批准通知書,對本公司近期業績不會產生影響。

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