四環醫藥(00460.HK)旗下軒竹生物與藥明合聯達成KM501雙抗ADC項目開發與生產戰略合作
格隆匯9月29日丨四環醫藥(00460.HK)連同其附屬公司軒竹生物科技有限公司("軒竹生物")，與藥明生物技術有限公司(股份代號：2269)旗下專注於生物偶聯藥物端到端服務的全球CDMO公司藥明合聯(WuXi XDC)("藥明合聯")聯合宣佈，軒竹生物大分子生物藥平台軒竹康明("軒竹康明")與藥明合聯針對一款創新腫瘤治療藥物KM501雙抗ADC達成研發和生產服務合作。
KM501雙抗ADC是一款軒竹康明自主開發的針對HER2中低表達的雙特異性抗體偶聯藥物，目前正處於新藥臨牀試驗申請(IND)前開發階段。
根據雙方合作協議，軒竹康明將通過藥明合聯的一體化CMC服務推進KM501雙抗ADC的研發進程。藥明合聯將在集中化區域內提供抗體、連接子、有效載荷、分析方法及工藝開發，偶聯原液和製劑開發及生產等端到端服務，支持KM501雙抗ADC的臨牀試驗申請。
此次與藥明合聯建立戰略合作，預計將加速賦能KM501雙抗ADC這一款創新雙抗偶聯藥物的開發。作為軒竹生物大分子生物藥創新產品線的重要項目之一，憑藉藥明合聯在生物偶聯藥物領域的端到端服務及豐富的項目服務經驗，預計將為KM501雙抗ADC未來順利提交IND申請提供有力支撐，助力該創新藥物加速進入臨牀試驗，早日驗證臨牀治療潛力，解決未滿足的臨牀需求。
據悉，KM501是軒竹生物旗下大分子平台軒竹康明自主開發的針對HER2-HER2的雙特異性抗體偶聯藥物。該產品抗體部分可以同時結合HER2的兩個非重疊表位ECD4(曲妥珠單抗靶向域)和ECD2(帕妥珠單抗靶向域)。這種獨特的設計可產生多種作用機制，包括雙重HER2信號阻斷、增強抗體與HER2的結合，從而增強HER2蛋白從細胞表面清除作用，提高抗體介導的抗腫瘤活性。
HER2陽性、HR陰性乳腺癌是HER2最大的應用領域，產品眾多，適應症豐富，2020年合計銷售額超過100億美元。HER2雙抗ADC作為新一代HER2ADC產品，有望在未來分享乳腺癌大市場，為更多的乳腺癌患者帶來福音。同時，HER2還在多種腫瘤如胃癌、膽管癌、結直腸癌中存在高表達，未來可潛在開發的適應症豐富，市場潛力巨大。
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