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海思科(002653.SZ):全資子公司獲鹽酸普拉克索緩釋片《藥品註冊證書》
格隆匯 11-30 12:03

格隆匯11月30日丨海思科(002653.SZ)宣佈,公司的全資子公司四川海思科製藥有限公司旗下全資子公司海思科製藥(眉山)有限公司於近日收到國家藥品監督管理局下發的關於鹽酸普拉克索緩釋片的《藥品註冊證書》。

該藥品用於治療成人特發性帕金森病的體徵和症狀,即在整個疾病過程中,包括疾病後期,當左旋多巴的療效逐漸減弱或者出現變化和波動(劑末現象或“開關”波動)時,都可以單獨應用該藥品(無左旋多巴)或與左旋多巴聯用。

普拉克索是新一代非麥角胺類多巴胺受體激動劑,生物利用度高,藥效迅速,不受食物影響,對合並抑鬱症的帕金森患者具有良好的療效。該藥於1997年通過FDA批准,用於治療原發性帕金森病(PD)。普拉克索可用於PD的各個階段,可以單獨應用於早期PD,或者作為輔助治療與左旋多巴聯用治療晚期PD。普拉克索是目前國內外PD診療指南推薦的一線用藥。

經查詢,鹽酸普拉克索緩釋片(每日服用一次)於2009年首次在歐盟上市,隨後於2010年在美國上市,2011年在日本上市。2014年8月,原研廠家勃林格殷格翰公司的鹽酸普拉克索緩釋片獲批在國內進口上市,規格為0.375mg、0.75mg、1.5mg、3mg和4.5mg。2020年7月和10月,京新藥業(002020.SZ)恆瑞醫藥(600276.SH)生產的鹽酸普拉克索緩釋片分別獲批國內上市,規格均為0.75mg和0.375mg。公司為同品種第3家,視同通過一致性評價,其中1.5mg規格為國內首家仿製。

據米內網數據顯示,普拉克索2019年在中國城市公立醫院、縣級公立醫院終端銷售額超過7.5億元人民幣,其中普拉克索緩釋片銷售額近1億元人民幣。

據IMS數據顯示,普拉克索2019年全球銷售額近6億美元,其中普拉克索緩釋片銷售額近3億美元。

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