貝達藥業(300558.SZ):埃克替尼新適應症上市許可申請納入優先審評程序
格隆匯10月22日丨貝達藥業(300558.SZ)宣佈,公司的產品鹽酸埃克替尼片(商品名:凱美納®,下稱“埃克替尼”)用於術後輔助治療上市許可申請於2020年10月12日被國家藥品監督管理局(下稱“NMPA”)藥品審評中心納入擬優先審評品種公示名單,現公示期滿,正式進入優先審評程序。
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,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-L858RNSCLC患者中獲優先推薦,也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,與競品相比具有明顯的差異化優勢。
埃克替尼術用於術後輔助治療上市許可申請於2020年9月22日獲得NMPA簽發的《受理通知書》,此次被納入優先審評程序,將有力推動埃克替尼術後輔助治療適應症早日獲批,進一步強化埃克替尼的差異化競爭優勢,為EGFR基因敏感突變的NSCLC早期患者提供一種優效低毒的術後輔助治療途徑。
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