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華海藥業(600521.SH):獲得“左乙拉西坦緩釋片”藥品註冊批件
格隆匯 06-01 17:59

格隆匯6月1日丨華海藥業(600521.SH)公佈,近日收到國家藥品監督管理局(以下簡稱“國家藥監局”)核准簽發的《藥品註冊批件》。

一、藥品的基本情況

藥品名稱:左乙拉西坦緩釋片

劑型:片劑

規格:0.5g、0.75g

申請事項:仿製藥申請

註冊分類:化學藥品3類

申報階段:生產

申請人:浙江華海藥業股份有限公司

藥品批准文號:國藥準字H20203226、國藥準字H20203227

審批結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,本品符合藥品註冊的有關要求,批准註冊,發給藥品批准文號。生產工藝、註冊標準、説明書及包裝標籤按所附執行,藥品有效期24個月。

左乙拉西坦緩釋片主要用於治療癲癇。左乙拉西坦緩釋片由UCBINC研發,於2008年9月獲FDA批准。左乙拉西坦緩釋片全球主要生產廠商有ACTAVISLABSFLINC,APOTEXINC,TEVAPHARMS等,國內生產廠商為深圳信立泰藥業股份有限公司。據統計,2019年左乙拉西坦製劑(包括所有制劑劑型)全球市場銷售額約21.866億美元(數據來源於PDB數據庫);2019年國內左乙拉西坦片(不包括緩釋片)全國等級醫院銷售額約人民幣8.87億元(數據來源於鹹達數據庫)。截至目前,公司在左乙拉西坦緩釋片研發項目上已投入研發費用約人民幣870萬元。

公司左乙拉西坦緩釋片獲得國家藥監局的《藥品註冊批件》,標誌着公司具備了在國內市場銷售該藥品的資格,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,公司左乙拉西坦緩釋片按新3類批准生產可視同通過一致性評價,並在醫保支付方面予以適當支持,醫療機構應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。

公司高度重視藥品研發,嚴格控制藥品研發、生產、銷售環節的質量和安全。但產品的生產和銷售容易受國家政策、市場環境等不確定因素的影響,有可能存在銷售不達預期等情況。敬請廣大投資者謹慎決策,注意防範投資風險。

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