我武生物(300357.SZ):獲得黃花蒿花粉變應原舌下滴劑兒童鼻炎III期臨牀試驗總結報吿
格隆匯1月24日丨我武生物(300357.SZ)公佈,日前,公司研發的“黃花蒿花粉變應原舌下滴劑”完成了“舌下含服‘黃花蒿粉滴劑’用於治療兒童變應性鼻炎的臨牀療效及安全性評價——多中心、隨機、雙盲、安慰劑平行對照的III期臨牀試驗”(簡稱“黃花蒿花粉變應原舌下滴劑兒童鼻炎III期臨牀試驗”),並形成了《黃花蒿花粉變應原舌下滴劑兒童鼻炎III期臨牀試驗總結報吿》。
藥物名稱:黃花蒿花粉變應原舌下滴劑;商品名稱:暢皓;註冊分類:治療用生物製品;劑型:滴劑藥品;批准文號:國藥準字S20210001。已獲得批准的適應症:該藥品是一種變應原提取物,作為特異性免疫治療用於經過敏原檢測為黃花蒿/艾蒿花粉過敏引起的變應性鼻炎(或伴有結膜炎)的成年患者。該次臨牀試驗的適應症:該藥品是一種變應原提取物,作為特異性免疫治療用於經過敏原檢測為黃花蒿/艾蒿花粉過敏引起的變應性鼻炎(或伴有結膜炎)的兒童患者(4-18歲)。
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