我武生物(300357.SZ):“黃花蒿花粉變應原舌下滴劑”獲得藥品註冊證書
格隆匯 2 月 7日丨我武生物(300357.SZ)公佈,近日,公司收到國家藥品監督管理局(“國家藥監局”)核准簽發的“黃花蒿花粉變應原舌下滴劑”《藥品註冊證書》。
本品包括以下5個規格:黃花蒿花粉變應原舌下滴劑1號:總變應原活性為25 BU/ml,裝量為2ml;
黃花蒿花粉變應原舌下滴劑2號:總變應原活性為128 BU/ml,裝量為2ml;
黃花蒿花粉變應原舌下滴劑3號:總變應原活性為640 BU/ml,裝量為2ml;
黃花蒿花粉變應原舌下滴劑4號:總變應原活性為3200 BU/ml,裝量為2ml;
黃花蒿花粉變應原舌下滴劑5號:總變應原活性為16000BU/m,裝量為2ml。
適應症:本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。
公司現有主導產品“粉塵蟎滴劑”(國藥準字S20060012)主要用於粉塵蟎過敏引起的過敏性鼻炎和過敏性哮喘的脱敏治療。過敏原分佈的區域性導致不同地區的患者對不同過敏原過敏,例如南方區域粉塵蟎過敏的患者人數較多,而黃花蒿/艾蒿花粉的過敏率則呈現北方高南方低的區域特徵。因此,“黃花蒿花粉變應原舌下滴劑”(國藥準字S20210001)與公司現有主導產品“粉塵蟎滴劑”互為補充,可以為更多過敏性疾病患者提供不同的變應原脱敏治療藥物。
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