石藥集團(01093.HK)：KN 026(安尼妥單抗注射液)的新藥上市申請獲國家藥品監督管理局受理
格隆匯9月11日丨石藥集團(01093.HK)公告，公司附屬公司石藥集團上海津曼特生物科技有限公司與江蘇康寧傑瑞生物製藥有限公司合作開發的KN026(安尼妥單抗注射液)("該產品")的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。
該產品本次按照治療用生物製品1類新藥申報，其適應症爲聯合化療用於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，HER2陽性局部晚期、復發或轉移性的胃╱胃—食管結合部腺癌。此前，該產品於2023年11月4日被國家藥監局藥品審評中心授予突破性治療認定，並於2025年8月28日獲優先審評審批資格。
該產品是一種抗HER2雙特異性抗體，可同時結合HER2的兩個非重疊表位，導致HER2信號阻斷。在2024年歐洲腫瘤內科學會(ESMO)大會上，該產品的II期臨牀研究結果首次公佈。該研究結果顯示，該產品聯合化療的客觀緩解率爲40.0%，經獨立評審委員會(IRC)評估的中位無進展生存期爲8.6個月，中位總生存期爲13.2個月。本次上市申請主要是基於一項關鍵II╱III期臨牀試驗(KC-WISE)。III期臨牀研究的首次期中分析結果顯示，與目前的標準治療相比，該產品聯合化療可顯著提高臨牀療效，延長無進展生存期和總生存期，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。
目前，HER2陽性胃癌二線治療尚無獲批上市的抗HER2藥物，該產品是中國首個在胃癌二線適應症中獲得陽性結果的抗HER2雙特異性抗體藥物。基於該產品關鍵II╱III期臨牀研究(KC-WISE)的首次期中分析結果，本集團已於2025年9月7日向國家藥監局遞交新藥上市申請。與此同時，本集團亦在積極推進該產品針對不同實體瘤適應症的多項臨牀試驗，其中胃癌及乳腺癌適應症的開發已處於關鍵III期臨牀試驗階段，以期使更多患者從中獲益。
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