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我武生物(300357.SZ):獲得變應原皮膚點刺試驗對照液III期臨牀試驗總結報吿
格隆匯 11-12 17:48

格隆匯11月12日丨我武生物(300357.SZ)公佈,日前,公司研發的“變應原皮膚點刺試驗對照液”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(變應原皮膚點刺試驗對照液)”(“變應原皮膚點刺試驗對照液III期臨牀試驗”),並形成了《變應原皮膚點刺試驗對照液III期臨牀試驗總結報吿》。

症:用於點刺試驗,作為變應原點刺液進行點刺試驗臨牀操作時的對照,提供判斷依據。

本品的效果評價分析結果顯示,納入本品效果評價的857例受試者中,陽性對照風團最大徑≥3mm且陰性對照風團最大徑<3mm的受試者為830例,本品的適用人羣比例為96.8%(830/857)。在配合變應原點刺液進行點刺試驗時,絕大多數受試者的陽性對照、陰性對照風團大小均符合預期範圍。本品的適用性良好。

由本品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,未發生常見的(發生人數比例≥1%)不良反應。本品的安全性良好。

綜上所述,本品適用於各變應原點刺液的點刺試驗中,作為臨牀操作時的對照,為點刺試驗結果的判讀提供可靠依據。

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

變應原皮膚點刺試驗對照液作為變應原點刺液進行點刺試驗臨牀操作時的對照,公司在研黃花蒿花粉點刺液8點刺液產品一同使用,提供點刺試驗判斷依據。滿足更多過敏性疾病患者的過敏原檢測需求。

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