紅日藥業(300026.SZ):鹽酸普拉克索緩釋片獲批上市
格隆匯8月2日丨紅日藥業(300026.SZ)公佈,公司於近日收到國家藥監局下發的關於鹽酸普拉克索緩釋片(0.375mg;1.5mg)的藥品註冊批件(批件號:2021S00813、2021S00814)。
鹽酸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。鹽酸普拉克索片是德國勃林格殷格翰藥業有限公司開發研製,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。
鹽酸普拉克索緩釋片通過緩釋技術使藥物緩慢釋放,每天僅需一次用藥(和普通片每日用藥量相同,但是普通片每日服用三次,每次一片),可更好地滿足國內患者需求,增加患者依從性,減少患者就醫費用,降低醫療成本,帶來良好的社會價值和經濟效益。
公司產品鹽酸普拉克索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,對公司的經營業績產生積極的影響。
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