我武生物(300357.SZ)收到“變應原點刺液”I期臨牀試驗總結報告
格隆匯12月30日丨我武生物(300357.SZ)公佈,日前,公司完成了“一項在中國志願者中探索同時進行多種變應原點刺液試驗耐受性的臨牀研究”(“‘變應原點刺液I期臨牀試驗”),並形成了《“變應原點刺液”I期臨牀試驗總結報告》。
藥物名稱:黃花蒿花粉點刺液、懸鈴木花粉點刺液、葎草花粉點刺液、白樺花粉點刺液、豚草花粉點刺液、德國小蠊點刺液、貓毛皮屑點刺液、狗毛皮屑點刺液;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、2017L04056、2017L04060、2017L04058、2017L04062、2017L04061、2017L04059、2017L04057臨牀試驗分期:I期臨牀研究;研究方法:單中心、開放、平行試驗;申辦方:浙江我武生物科技股份有限公司;研究單位:中南大學湘雅三醫院。
截至公告披露日,經查詢國家藥品監督管理局官網,尚無其他企業取得該等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。
綜合相關安全性指標表明,該研究設計的各變應原點刺液的兩個劑量組均具有較好的安全性。研究者認為該兩個劑量組中的各變應原點刺液劑量濃度均可被用於下一步臨牀研究。公司目前正積極籌備本品後續的臨牀研究工作,將根據進展情況及時履行信息披露義務。
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