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華海藥業(600521.SH):奧氮平片獲藥品註冊證書
格隆匯 11-10 17:11

格隆匯 11 月 10日丨華海藥業(600521.SH)公佈,公司於日收到國家藥品監督管理局(“國家藥監局”)核准簽發的奧氮平片《藥品註冊證書

奧氮平片主要用於治療精神分裂症。對奧氮平初次治療有效的患者,鞏固治療可以有效維持臨牀症狀改善。奧氮平用於治療中、重度躁狂發作。對奧氮平治療有效的躁狂發作患者,奧氮平可以預防雙相情感障礙的復發。

奧氮平片禮來研發,最早於1996年在瑞典上市。全球主要生產廠商有DR REDDYS LABS LTDZYDUS PHARMSAPOTEX INC等,國內生產廠商主要廣東東陽光藥業有限公司、江蘇豪森藥業集團有限公司、四川科倫藥業股份有限公司據統計,2019奧氮平製劑產品(包括全部製劑劑型)全球市場銷售額約13.765億美元(數據來源於PDB數據庫);2019年國奧氮平片(包括普通片劑和口崩片)全國等級醫院銷售額約人民18.28億元(數據來源於鹹達數據庫)。

截止目前,公司在奧氮平片研發項目上已投入研發費用約人民幣836.60元。

奧氮平片獲得國家藥監局的《藥品註冊證書》,標誌着公司具備了在國內市場銷售藥品的資格,進一步豐富了公司的產品線,有助於提升公司產品的市場競爭力。根據國家相關政策,公司奧氮平片化學藥品4類批准生產可視同通過一致性評價醫療機構將會優先採購併在臨牀中優先選用,有利於擴大產品的市場銷售,對公司的經營業績產生積極的影響。

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