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我武生物(300357.SZ):獲得黃花蒿花粉點刺液III期臨牀試驗總結報吿
格隆匯 11-12 17:46

格隆匯11月12日丨我武生物(300357.SZ)公佈,日前,公司研發的“黃花蒿花粉點刺液”完成了“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—多中心、開放的III期臨牀試驗(黃花蒿花粉點刺液)”(“黃花蒿花粉點刺液III期臨牀試驗”),並形成了《黃花蒿花粉點刺液III期臨牀試驗總結報吿》。

症:用於點刺試驗,輔助診斷因黃花蒿/艾蒿花粉致敏引起的I型變態反應性疾病。

本研究的效果評價分析結果顯示,進入效果評價集的黃花蒿花粉變應原陽性組受試者例數為438例,其中經點刺試驗後判定為陽性的例數為426例,靈敏度為97.26%進入效果評價集的黃花蒿花粉變應原陰性組受試者例數為395例,其中經點刺試驗後判定為陰性的例數為335例,特異度為84.81%黃花蒿花粉點刺液在診斷由黃花蒿/艾蒿花粉引起的過敏性疾病中具有很高的靈敏度和較高的特異度。

由本研究的安全性分析結果可見,未發生3級及以上的不良事件,未發生嚴重不良事件,未發生導致退出的不良事件。不良反應大多為黃花蒿花粉點刺液點刺部位的局部不良反應。黃花蒿花粉點刺液安全性良好。

綜上所述,黃花蒿花粉點刺液作為一種安全性較好的過敏原臨牀輔助診斷工具,具有較充分的診斷價值,可為過敏性疾病的治療提供可靠依據。

公司目前正在積極準備品種藥品上市許可申請,將根據進展情況及時履行信息披露義務。

黃花蒿花粉點刺液”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)產互為補充,可以滿足更多過敏性疾病患者的過敏原檢測需求。

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