聖諾生物(688117.SH):醋酸艾替班特注射液獲得藥品註冊證書
格隆匯4月21日丨聖諾生物(688117.SH)公佈,公司全資子公司成都聖諾生物製藥有限公司於近日收到國家藥品監督管理局簽發的關於醋酸艾替班特注射液的《藥品註冊證書》。
醋酸艾替班特注射液是Shire公司研發,於2008年在國外上市的遺傳性血管水腫專治藥物,被我國衞健委納入《第一批鼓勵仿製藥品目錄建議清單》,其適應症為成年遺傳性血管水腫(HAE)急性發作,公司是國內外首家向美國FDA提交DMF備案的艾替班特仿製藥原料藥企業。
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