康寧傑瑞製藥-B(09966.HK)：KN026(安尼妥單抗注射液)新藥上市申請獲國家藥監局受理
格隆匯9月11日丨康寧傑瑞製藥-B(09966.HK)公告，與石藥集團有限公司(股份代號：1093)附屬公司上海津曼特生物科技有限公司合作開發的KN026聯合化療用於治療至少接受過一種系統性治療(必須包含曲妥珠單抗聯合化療)失敗的人表皮生長因子受體2("HER2")陽性("HER2+")局部晚期、復發或轉移性胃╱胃－食管結合部腺癌("GC/GEJ")患者的新藥上市申請("新藥上市申請")，已獲中華人民共和國國家藥品監督管理局受理。本次新藥上市申請主要是基於一項關鍵II/III期臨牀試驗，其期中分析結果顯示，與現有標準治療相比，KN026聯合化療顯著提高臨牀療效，延長患者的無進展生存期("PFS")和總生存期("OS")，且在安全性方面無新發安全性風險，心臟毒性發生率低，免疫原性低。
此外，KN026已於2023年11月4日獲國家藥監局藥品審評中心授予突破性治療藥物認定，並已於2025年8月28日獲優先審評審批資格。
目前，HER2+胃癌二線治療尚無獲批上市的抗HER2藥物，KN026是中國首個在胃癌二線治療中獲得陽性結果的抗HER2雙特異性抗體藥物。KN026的II期臨牀試驗結果於2024年歐洲腫瘤內科學會年會首次公佈，該結果顯示，KN026聯合化療的客觀緩解率爲40.0%，經獨立評審委員會評估的中位PFS爲8.6個月。
KN026旨在成爲全球性新一代HER2靶向療法。憑藉其創新的結構，可同時結合至兩種不同的經臨牀驗證的HER2表位(表位II及IV)，並保留野生型Fc區。這使得KN026能夠(i)雙重阻斷HER2相關信號通路；(ii)增強與HER2受體的結合；(iii)減少細胞表面的HER2蛋白；及(iv)通過完整的抗體依賴性細胞介導的細胞毒性增強對腫瘤的殺傷效果。該等結合機制使KN026表現出卓越的腫瘤抑制作用。
目前，正在中國進行多項III期臨牀試驗，包括KN026聯合多西他賽(白蛋白結合型)一線治療HER2+乳腺癌("BC")、KN026聯合化療二線及以上治療HER2+GC/GEJ，以及KN026聯合多西他賽(白蛋白結合型)針對BC的新輔助治療。
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