我武生物(300357.SZ):黃花蒿花粉變應原舌下滴劑進入行政審批階段
格隆匯1月25日丨我武生物(300357.SZ)公佈,近日,公司從國家藥品監督管理局藥品審評中心(簡稱“CDE”)“申請人之窗”查詢獲知“黃花蒿花粉變應原舌下滴劑”藥品註冊審評的最新進展狀態。當前品種技術審評建議結論為:批准生產。CDE已結束該註冊申請的技術審評工作,已於2021年1月21日報送國家藥品監督管理局進行審批。
該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。截至該公吿披露日,經查詢國家藥品監督管理局官網,尚無有其他企業取得該品種的《藥品註冊批件》。
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”與公司現有主導產品“粉塵蟎滴劑”互為補充,有望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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