翰森製藥(03692.HK)甲磺酸阿美替尼片獲藥品註冊批件
格隆匯3月19日丨翰森製藥(03692.HK)公佈,由公司附屬公司江蘇豪森藥業集團有限公司開發的1類創新藥「甲磺酸阿美替尼片(商品名稱阿美樂)已獲中國國家藥品監督管理局頒發藥品註冊批件。
阿美樂獲批上市,成為中國首個第三代表皮生長因子受體(EGFR)酪氨酸激酶抑制劑(EGFR-TKI)。阿美樂能夠不可逆地、高選擇性抑制EGFR敏感突變和T790M耐藥突變,不僅顯示出良好的療效和安全性,且對腦轉移的患者有效,用於既往經EGFR-TKI治療進展,且T790M突變陽性的局部晚期或轉移性非小細胞肺癌(NSCLC)成人患者的治療。
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