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中源協和(600645.SH):目前公司幹細胞藥物獲得藥物臨牀試驗批准的數量為國內第一
格隆匯 01-26 17:33

格隆匯1月26日丨中源協和(600645.SH)在投資者互動平台表示,根據公開數據整理,目前世界各地的監管機構批准的MSCs療法共十餘項,適應症包括:GVHD、克羅恩病、骨關節損失等,MSCs來源有骨髓、脂肪、臍帶血等。 隨着我國近幾年來配套政策不斷完善,幹細胞藥物的申報數量、申報企業逐年增多,根據公開數據統計,目前已有約50家企業的百項幹細胞藥物向NMPA提交IND,但尚未有幹細胞藥物獲批上市。中源協和全資子公司及參股公司共有兩款藥物七個適應症收到NMPA核准簽發的《藥物臨牀試驗批准通知書》,適應症包括:慢性牙周炎、治療臨牀分型為重型/危重型新型冠狀病毒感染、失代償期肝硬化、特發性肺纖維化、慢加急性(亞急性)肝衰竭、激素治療失敗的II度至IV度急性移植物抗宿主病和中、重度急性呼吸窘迫綜合徵。根據CDE數據統計,目前公司幹細胞藥物獲得藥物臨牀試驗批准的數量為國內第一。

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