華北製藥(600812.SH):子公司奧木替韋單抗注射液獲批上市
格隆匯1月25日丨華北製藥(600812.SH)公佈,公司從子公司華北製藥集團新藥研究開發有限責任公司(“新藥公司”)獲悉,根據國家藥品監督管理局網站顯示,國家藥品監督管理局通過優先審評審批程序批准新藥公司申報的奧木替韋單抗注射液(英文名: Ormutivimab Injection)上市。
該產品為重組人源抗狂犬病毒單抗注射液,國際非專利通用名稱為Ormutivimab,中文通用名稱為奧木替韋單抗。該品種是新藥公司自主研發項目,其作用機制及適應症為將該品與人用狂犬病疫苗聯用,用以補充人用狂犬病疫苗主動免疫過程中的抗體空白,可直接中和體內狂犬病毒,起到被動免疫作用,用於被狂犬或其它狂犬病毒易感動物咬傷、抓傷患者的被動免疫。
截至目前,該藥品累計研發投入1.987億元人民幣。
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