安科生物(300009.SZ):“人干擾素α 2b噴霧劑”臨牀試驗申請獲受理
格隆匯4月14日丨安科生物(300009.SZ)宣佈,近日,公司收到國家藥品監督管理局行政許可文書《受理通知書》,公司申報的“人干擾素α 2b噴霧劑”臨牀試驗申請已獲得受理,受理號為:CXSL21****5國。
該次申請的人干擾素α 2b噴霧劑擬用於治療由病毒感染引起的兒童皰疹性咽峽炎,給藥方式為口咽部給藥。該藥品是在公司已上市人干擾素α 2b注射液的基礎上研發的新型給藥製劑,具有不含防腐劑,粘膜給藥無刺激、給藥方便和不良反應少等優勢。目前尚無針對相關適應症的人干擾素α 2b噴霧劑上市。
干擾素α具有廣譜抗DNA病毒和RNA病毒的作用,人干擾素α 2b臨牀上被廣泛用於治療各種病毒性疾病,公司目前擁有人干擾素α 2b凍乾粉、注射液、滴眼液、栓劑、乳膏等多種劑型。
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