基石藥業-B(02616.HK):RET抑制劑普吉華®(普拉替尼膠囊)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藥品審評中心受理
格隆匯4月9日丨基石藥業-B(02616.HK)發佈公吿,RET抑制劑普吉華®(普拉替尼膠囊)轉移至境內生產的藥品上市註冊申請已獲中國國家藥品監督管理局 (NMPA)藥品審評中心受理。此前,基石藥業另一款精準治療藥物泰吉華®(阿伐替尼片)轉移至境內生產的藥品上市註冊申請已在 2023年6月獲藥審中心受理,目前正在審評中,預計2024年將實現國內供應。
基石藥業首席執行官兼執行董事楊建新博士表示:“普吉華®與泰吉華®轉移至境內生產的兩項上市註冊申請先後獲得受理,對於基石藥業具有重大的意義,意味着公司將有望在短期內實現上述兩個產品的本地化生產,這不僅能夠實現超過50%的藥品生產成本降幅,還能增加產品供應的靈活性、更好地滿足國內市場需求、惠及更多國內患者,並將進一步拓展普吉華®與泰吉華®在中國市場的競爭優勢。最近,國家陸續推出了一系列地產化相關支持性政策,如簡化申報資料、明確申報路徑、優化申報流程等。NMPA在新出的優化程序徵求意見稿中明確該類地產化申請適用優先審評審批程序。作為地產化藥品的探索者,我們期待這些政策能夠加速地產化藥品的批准和上市進程,從而使基石藥業能夠迅速擴大普吉華®與泰吉華®的適應症範圍。”
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