貝達藥業(300558.SZ):埃克替尼術後輔助治療適應症獲批
格隆匯6月4日丨貝達藥業(300558.SZ)宣佈,公司今日收到國家藥監局核准簽發的《藥品註冊證書》。經審查,鹽酸埃克替尼片(商品名:凱美納®)符合藥品註冊的有關要求,批准新增適應症,發給藥品註冊證書。新增適應症為:“本品單藥適用於 II-IIIA 期伴有表皮生長因子受體(EGFR)基因敏感突變非小細胞肺癌(NSCLC)術後輔助治療。”。
埃克替尼是公司自主研發的我國第一個擁有自主知識產權的小分子靶向抗癌藥,與其他一代EGFR-TKI相比,具有明顯的差異化優勢,其療效確切、肝毒性低、安全性高,循證醫學臨牀證據豐富,中國人羣數據全,在CSCO指南、衞健委診療規範及腦轉移人羣、21-L858R NSCLC患者中獲優先推薦,是目前唯一繼續開展後續免費用藥項目的一代EGFR-TKI原研藥。自2011年6月上市至今,埃克替尼累計銷售收入已超過90億元人民幣。
術後輔助治療適應症是埃克替尼在國內獲批的第三項適應症,其藥品註冊申請於2020年9月獲得藥監局受理,2020年10月納入優先審評品種名單,2020年11月收到臨牀試驗數據核查通知。
針對Ⅱ-IIIA期肺癌EGFR突變患者術後輔助治療對照試驗(EVIDENCE研究)的研究結果顯示,埃克替尼的療效優於標準輔助化療,能顯著延長患者無病生存期且安全性更優。
截至該公吿日,除埃克替尼外,國內尚無經批准用於EGFR基因敏感突變NSCLC患者術後輔助治療的一代EGFR-TKI。
取得藥品註冊證書後,埃克替尼成為中國第一個獲准用於早期肺癌患者術後輔助治療的一代EGFR-TKI,公司將藉此拓寬埃克替尼的市場,夯實埃克替尼在中國肺癌靶向藥市場的領先地位。本次新增適應症將對公司營收帶來積極影響。
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