賽升藥業(300485.SZ):注射用甲磺酸萘莫司他藥品註冊申請獲受理
格隆匯12月16日丨賽升藥業(300485.SZ)公佈,公司於近日收到國家藥監局下發的注射用甲磺酸萘莫司他藥品註冊受理通知書,國家藥監局根據《中華人民共和國行政許可法》第三十二條的規定,對上述藥品的藥品註冊申請進行了審查,決定予以受理。
注射用甲磺酸萘莫司他用於改善胰腺炎的急性症狀;治療彌散性血管內凝血綜合徵(DIC);用於防止有出血性病變或出血傾向的患者血液體外循環時灌流血液的凝固(血液透析和血漿置換)。
同時,甲磺酸萘莫司他為新型的蛋白酶抑制劑,對胰蛋白酶、補體系統、凝血纖溶系統及血小板凝集,具有強力且廣泛的抑制作用。通過可逆性抑制胰蛋白酶樣絲氨酸蛋白酶發揮藥理作用。
經查詢國家藥監局網站,國內目前僅有江蘇杜瑞製藥有限公司獲得了注射用甲磺酸萘莫司他的藥品批准文號。
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