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科倫博泰生物-B(06990.HK):核心產品蘆康沙妥珠單抗(SAC-TMT)的新藥申請獲國家藥品監督管理局受理
格隆匯 08-19 20:55

格隆匯8月19日丨科倫博泰生物-B(06990.HK)公吿,基於蘆康沙妥珠單抗(sac-TMT,前稱SKB264/MK-2870)OptiTROP-Lung03關鍵研究積極結果的新藥申請(NDA)已獲中國國家藥品監督管理局(NMPA)藥品審評中心(CDE)受理。

OptiTROP-Lung03是一項多中心、隨機、關鍵臨牀研究,評估了蘆康沙妥珠單抗(sac-TMT)單一療法每兩週(Q2W)5mg/kg靜脈注射對比多西他賽治療接受表皮生長因子受體酪氨酸激酶抑制劑(EGFR-TKI)療法和含鉑化療治療失敗後的局部晚期或轉移性EGFR突變非小細胞肺癌(NSCLC)患者的結果。在預設的分析中,與多西他賽相比,蘆康沙妥珠單抗(sac-TMT)單一療法在客觀緩釋率(ORR)和無進展生存期(PFS)方面具有顯著統計學意義和臨牀意義的改善。

公司已就蘆康沙妥珠單抗(sac-TMT)治療接受EGFR-TKI和含鉑化療治療失敗後的局部晚期或轉移性EGFR突變NSCLC成人患者提交該申請。

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