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貝達藥業(300558.SZ):甲磺酸貝福替尼膠囊取得Ⅱ/Ⅲ期臨牀試驗總結報吿
格隆匯 11-09 17:37

格隆匯11月9日丨貝達藥業(300558.SZ)公佈,近日,公司在研產品甲磺酸貝福替尼(簡稱“D-0316”)膠囊在完成Ⅱ/Ⅲ期臨牀試驗後,經過一系列數據管理和統計分析工作已取得臨牀試驗總結報吿。

甲磺酸貝福替尼膠囊是第三代表皮生長因子受體酪氨酸激酶抑制劑(EGFR-TKI)。該研究是一項多中心、隨機、開放、平行對照的II/III期臨牀試驗,在既往未經治療的EGFR敏感突變局部晚期或轉移性非小細胞肺癌(簡稱“NSCLC”)362例受試者中,評估D-0316對比埃克替尼(凱美納®)作為一線治療的療效和安全性。

研究結果顯示,D-0316膠囊治療既往未經治療的EGFR敏感突變局部晚期或轉移性NSCLC受試者的療效優於埃克替尼,安全性可控,可為EGFR敏感突變晚期NSCLC初治患者提供新的有效的治療選擇。

截至目前,國內已有奧希替尼、阿美替尼和伏美替尼三款第三代EGFR-TKI獲得批准及上市。

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