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基石藥業-B(02616.HK):泰吉華®(阿伐替尼片)100mg規格由境外轉移至境內生產的藥品上市註冊申請已獲國家藥監局批准
格隆匯 08-15 08:03

格隆匯8月15日丨基石藥業-B(02616.HK)發佈公吿,泰吉®(阿伐替尼片)100mg規格,轉移至境內生產的藥品上市註冊申請已獲中國國家藥品監督管理局(“NMPA”)批准。繼泰吉®300mg規格於2024年6月獲NMPA批准後,其100mg規格的批准進一步豐富了泰吉®的用藥選擇靈活性。預計兩種規格均將於2024年底或2025年初逐步替代現有進口產品,實現國產化供應。

基石藥業首席執行官、研發總裁、董事會執行董事楊建新博士表示:“泰吉華®100mg和300mg 規格轉移至境內生產的藥品上市註冊申請雙雙獲批,不僅能夠更好地滿足不同患者的需求、為患者提供便利,而且大大提高了泰吉華®在國內的可及性和和市場競爭力。我們另一精準治療產品普吉華®(普拉替尼膠囊)轉移至境內生產的藥品上市註冊申請已於今年4月獲得受理,目前正處於NMPA藥品審評中心審評階段。我們將繼續致力於通過先進的製造技術、嚴格的生產和品質管制,為國內患者提供高品質的藥品。”

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