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我武生物(300357.SZ):獲得屋塵蟎膜劑藥物臨牀試驗批准通知書
格隆匯 12-16 17:26

格隆匯12月16日丨我武生物(300357.SZ)公佈,日前,公司從國家藥品監督管理局網上辦事大廳下載獲得《藥物臨牀試驗批准通知書》,由公司提交的"屋塵蟎膜劑"藥物臨牀試驗申請獲得批准。註冊分類為治療用生物製品1類。適應症為作為特異性免疫治療方式,用於塵蟎致敏相關的變應性鼻炎(伴或不伴過敏性結膜炎、過敏性哮喘)的成人患者。

本品獲得《藥物臨牀試驗批准通知書》後,將進行I期、II期、III期臨牀試驗、上市許可申請等主要環節後方可上市銷售,其結果存在較大不確定性。目前,公司正在積極籌備本品的I期臨牀試驗,將根據進展情況及時履行信息披露義務。

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