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康寧傑瑞製藥-B(09966.HK)KN026及KN046的聯合療法獲美國FDA授予孤兒藥資格
格隆匯 12-23 07:33

格隆匯 12 月 23日丨康寧傑瑞製藥-B(09966.HK)發佈公告,由公司全資附屬公司江蘇康寧傑瑞生物製藥有限公司開發的 KN026(一種重組人源化抗HER2雙特異性抗體)及KN046(一種重組人源化PDL1/CTLA-4雙特異性抗體)的聯合療法(“KN026+KN046聯合療法”)獲美國食品藥品監督管理局(“FDA”)授予孤兒藥資格(“ODD”),用於治療GC及GEJ。這是集團的第三個ODD。早前於2020年1月及2020年9月, KN035(一種由集團開發的重組人源化單域抗體)及KN046分別獲美國FDA授予ODD,用於治療膽道癌及胸腺上皮腫瘤。

公告表示,KN026和KN046是集團自主研發並全權擁有的雙特異性抗體創新藥,兩種藥物在單藥臨牀試驗中均顯示出良好的安全性、耐受性和抗腫瘤療效,由研究者發起的一項KN026+KN046聯合療法臨牀試驗取得了優異的療效。早期研究顯示,對於全部14名可評價患者,KN026+KN046聯合療法在HER2陽性實體瘤中的客觀緩解率為64.3%,疾病控制率高達92.9%,相關臨牀數據已在第35屆癌症免疫治療學會年會上展示。

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