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四環醫藥(00460.HK):抗癲癇藥拉考沙胺片獲批上市
格隆匯 09-08 12:10

格隆匯9月8日丨四環醫藥(00460.HK)宣佈,公司全資附屬公司北京四環製藥有限公司(“北京四環”)開發的拉考沙胺片(50mg及100mg)已於2021年9月1日獲得中華人民共和國國家藥品監督管理局頒發的《藥品註冊批件》,批准該藥品生產,視同通過質量和療效一致性評價。

中國約有900萬癲癇患者,並且每年新增約60萬患者。在中國,癲癇已經成為神經科僅次於頭痛的第二大常見病,癲癇病的治療需要較長的週期,甚至終生服藥。拉考沙胺片適用於16歲及以上癲癇患者部分性發作的聯合治療,副作用小,不經過肝臟代謝,與其他抗癲癇藥物不會產生有臨牀意義的重大藥物相互作用,並且由於其獨特的作用機制,可作為部分癲癇發作患者新的治療選擇。

拉考沙胺原研藥由UCB製藥研發,最早於2008年8月及10月分別獲得歐盟和美國藥監局批准上市。於2018年11月,UCB製藥的拉考沙胺片獲批進入國內市場,作為國內首個上市的第三代抗癲癇藥物,拉考沙胺片具有巨大的市場潛力。

Cortellis資料顯示,拉考沙胺2018年、2019年及2020年的年度全球銷售額分別為13.22億美元、15.46億美元及17.08億美元,銷售額逐年遞增。於國內市場,據米內網資料,2019年及2020年中國樣本醫院終端年度拉考沙胺片銷售額分別為人民幣193萬元及人民幣1,234萬元,市場處於快速增長的階段。

集團開發的拉考沙胺片(50mg及100mg)已獲批准生產上市及視同通過一致性評價,進一步豐富了集團的抗癲癇產品線。憑藉集團奧卡西平片銷售的優勢,該藥品預計將很快上市銷售,進一步惠及廣大患者。同時,憑藉自有原料藥╱原材料的優勢,集團有望在未來生產過程中降低成本,有利於該藥品未來的營銷、銷售和市場競爭,且預期對集團的經營業績產生積極影響。

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