中源協和(600645.SH):VUM02注射液臨牀試驗申請獲受理
格隆匯1月5日丨中源協和(600645.SH)公佈,公司全資子公司武漢光谷中源藥業有限公司於2023年1月5日取得國家藥監局藥品審評中心(CDE)簽發的關於VUM02注射液臨牀試驗申請《受理通知書》,受理號為CXSL2300006國。截至該公吿日,公司對該項目的累計研發投入為人民幣844.75萬元。
VUM02注射液(人臍帶源間充質幹細胞注射液)是公司自主研發的冷凍保存型幹細胞製劑,是由健康胎兒臍帶組織經體外分離、篩選、擴增後製備的人臍帶源間充質幹細胞(UC-MSC)懸液,臨牀擬用於治療特發性肺纖維化患者。
截至該公吿日,全球尚未有用於治療特發性肺纖維化的同類細胞藥物上市,研發進展最快的同類藥物處於臨牀試驗階段。按照國家衞生健康委員會等5部門聯合制定的《第一批罕見病目錄》,特發性肺纖維化在國屬於罕見病。
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