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華海藥業(600521.SH):左乙拉西坦注射用濃溶液獲得藥品註冊證書
格隆匯 04-07 16:53

格隆匯4月7日丨華海藥業(600521.SH)公佈,公司於近日收到國家藥監局核准簽發的左乙拉西坦注射用濃溶液的《藥品註冊證書》,經審查,本品符合藥品註冊的有關要求,批准註冊,發給藥品註冊證書。

左乙拉西坦注射用濃溶液主要用於治療癲癇。左乙拉西坦注射用濃溶液最早由比利時UCB公司研發,於2006年在美國被批准上市。目前美國主要生產廠商有Hikma Farmaceutica、Mylan Labs Ltd等,國內生產廠商主要有江蘇萬高藥業股份有限公司、海南普利製藥股份有限公司等。據統計,2020年左乙拉西坦注射用濃溶液國內銷售額約人民幣1.64億元(數據來源於米內網)。

截止目前,公司在左乙拉西坦注射用濃溶液研發項目上已投入研發費用約人民幣1253萬元(含美國項目研發投入)。

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