康寧傑瑞-B(09966.HK)石藥(01093.HK)KN026獲藥監局授突破性治療認定
康寧傑瑞製藥-B(09966.HK)及石藥集團(01093.HK)公布,由康寧傑瑞旗下江蘇康寧傑瑞生物製藥及石藥集團附屬上海津曼特生物科技,合作開發的重組人源化抗HER2雙特異性抗體注射液KN026,近日獲國家藥監局授予突破性治療認定,擬定適應症為聯合化療藥物,用於一線標準治療(曲妥珠單抗聯合化療)失敗的HER2陽性局部晚期、復發或轉移性的胃癌,包括胃食管結合部腺癌。
康寧傑瑞預期,該認定將加速KN026在二線或以上療法中治療HER2陽性GC/GEJ的臨床開發及其上市進程。
而石藥集團表示,KN026在該適應症的3期臨床試驗處於入組階段,目前該試驗正在順利進行中,今次獲授予突破性治療認定,將進一步加快其研發和審評速度。
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