艾力斯(688578.SH):甲磺酸伏美替尼片納入擬突破性治療品種公示
格隆匯11月23日丨艾力斯(688578.SH)公佈,公司核心產品甲磺酸伏美替尼片(商品名“艾弗沙”,“伏美替尼”)近日被國家藥品監督管理局藥品審評中心(“藥審中心”)納入擬突破性治療品種公示名單,公示期為2021年11月23日—2021年11月30日。
甲磺酸伏美替尼片是一種表皮生長因子受體酪氨酸激酶抑制劑(EGFR-TKI),為公司自主研發的1類新藥,屬於小分子靶向藥,是目前公司的核心產品,用於晚期非小細胞肺癌(NSCLC)的治療。其二線治療適應證已於2021年3月3日獲批上市;其用於一線治療EGFR敏感突變的局部晚期或轉移性NSCLC的全國多中心、隨機對照、雙盲的III期臨牀研究已達到主要研究終點,相比一代EGFR-TKI吉非替尼(易瑞沙)治療對照組,伏美替尼治療組顯示了具有顯著統計學意義和臨牀意義的PFS獲益,相關研究數據將在後續國際學術大會上正式公佈。
目前,伏美替尼已被寫入多項最新權威指南,包括《中華醫學會腫瘤分會肺癌臨牀診療指南(2021版)》《IV期原發性肺癌中國治療指南(2021年版)》《肺癌腦轉移中國治療指南(2021年版)》《CSCO非小細胞肺癌指南(2021年版)》等,其差異化的臨牀優勢獲得了業內專家廣泛認同。
公司預計,將於2021年底申報一線治療新藥上市申請(NDA),2022年一線治療適應證獲批。
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