我武生物(300357.SZ):通過藥品GMP符合性檢查
格隆匯 4 月 7日丨我武生物(300357.SZ)公佈,近日,公司從浙江省藥品監督管理局網站獲悉藥品GMP符合性檢查結果(浙2021第0025號)。
檢查範圍:治療用生物製品(黃花蒿花粉變應原舌下滴劑);檢查結論:依據《藥品管理法》(2019年修訂)及藥品生產監督管理的有關要求對浙江我武生物科技股份有限公司進行藥品生產質量管理規範符合性檢查和審核,結果符合要求。
截至公吿披露日,經查詢國家藥品監督管理局網站,尚未有其他企業取得該品種(黃花蒿花粉變應原舌下滴劑)的藥品批准文號。
“黃花蒿花粉變應原舌下滴劑”(國藥準字S20210001)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)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,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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