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麗珠集團(000513.SZ):注射用丹曲林鈉獲藥品註冊證書
格隆匯 10-23 22:31

格隆匯10月23日丨麗珠集團(000513.SZ)公佈,近日,公司下屬全資子公司麗珠集團麗珠製藥廠(“麗珠製藥廠”)收到國家藥品監督管理局核准簽發的《藥註冊證書》(證書編號2020S00668),藥品通用名稱為注射用丹曲林鈉

注射用丹曲林鈉歷經10年研發,是公司自主研發的仿製藥,適應症為用於預防及治療惡性高熱。惡性高熱屬於罕見病,是一種具有家族遺傳性的肌肉病,是主要由揮發性吸入麻醉藥和去極化肌鬆藥-琥珀酰膽鹼所觸發的骨骼肌異常高代謝狀態。在沒有特異性治療藥物的情況下,一般的臨牀降温措施難以控制體温的增高,最終可導致患者死亡。

該產品為國內首仿,麗珠製藥廠首次提交本品生產申請的受理時間為20190201日(受理號:CYHS1900135國)。

截至公告日,注射用丹曲林鈉累計直接投入的研發費用約為人民幣1722.34萬元。

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