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基石藥業(02616.HK):普吉華由境外轉移至境內生產藥品上市申請獲內地批准
阿思達克 07-10 08:19
基石藥業(02616.HK)公布,其RET抑制劑普吉華(普拉替尼膠囊,100mg)由境外轉移至境內生產的藥品上市申請,已獲國家藥監局批准。預計於2026年起,該產品在中國市場的供應將由進口產品逐漸過渡為國內地產化產品。 基石藥業首席執行官、研發總裁、執行董事楊建新表示,普吉華地產化上市申請獲批是公司在藥品全生命周期管理,特別是生產製造和質量管理體系建設上的又一個重要里程碑。此次獲批意味著普吉華將實現從原料藥(API)到製劑(DP)的完全本地化生產。
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