我武生物(300357.SZ):黃花蒿花粉點刺液等產品III期臨牀試驗獲倫理委員會審查批件
格隆匯5月14日丨我武生物(300357.SZ)公佈,日前,首都醫科大學附屬北京同仁醫院倫理委員會出具了審查批件(TREC2020-14),同意開展“一項在中國(北方)過敏受試者中同時進行多種變應原點刺液試驗有效性及安全性的臨牀研究”。該研究涉及的“變應原點刺液”已完成III期臨牀的準備工作,即將進入III期臨牀試驗階段。
藥物名稱:黃花蒿花粉點刺液、葎草花粉點刺液、白樺花粉點刺液、豚草花粉點刺液、變應原皮膚點刺試驗對照液;;註冊分類:治療用生物製品第4類——變態反應原製品劑型:皮膚點刺試劑;適應症:用於點刺試驗,輔助診斷I型變態反應性疾病;臨牀批件號:2017L04055、2017L04060、2017L04058、2017L04062、2017L04054;臨牀試驗分期:III期臨牀試驗;研究方法:多中心、開放試驗。
截至公告披露日,經查詢國家藥品監督管理局官網,尚無其他企業取得上述產品的藥品註冊批件。上述點刺相關產品用於點刺試驗,輔助診斷因相應變應原致敏引起的I型變態反應性疾病,與公司已上市的“粉塵蟎皮膚點刺診斷試劑盒”(國藥準字S20080010)、“屋塵蟎皮膚點刺診斷試劑盒”(國藥準字S20190022)產品相互補充,可以滿足更多過敏性疾病患者的變應原檢測需求。
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