康寧傑瑞製藥-B(09966.HK):JSKN003獲美國FDA批準開展一項治療不限HER2表達水平的PROC的II期臨牀研究
格隆匯7月31日丨康寧傑瑞製藥-B(09966.HK)宣佈,JSKN003已獲美國食品藥品監督管理局("FDA")批準,在美國開展一項I I期臨牀研究(研究編號:JSKN003-202)。JSKN003-202是JSKN003的一項隨機、開放式標籤、多中心的II期臨牀研究,用於治療鉑耐藥複發性上皮性卵巢癌、原發性腹膜癌或輸卵管癌(統稱爲鉑耐藥卵巢癌,"PROC"),且不限人表皮生長因子受體2("HER2")表達水平。此臨牀試驗旨在評估JSKN003在上述人羣中的療效和安全性,並確定推薦III期劑量。此次JSKN003-202獲美國FDA批準,是公司推動創新管線全球開發的重要里程碑,將持續提升本公司在抗腫瘤治療領域的核心競爭力。
JSKN003是一種靶向HER2雙表位抗體偶聯藥物("ADC"),其通過糖基定點偶聯技術將拓撲異構酶I抑制劑連接至抗體KN026(重組人源化抗HER2雙特異性抗體)的N糖基化位點處。點擊反應偶聯物較馬來醯亞胺-邁克爾反應的偶聯物具有更好的血清穩定性。雙表位HER2靶向性使JSKN003具有更強的內吞誘導及旁觀者殺傷效應,使其在HER2表達腫瘤中具有較強的抗腫瘤活性。於2024年9月,公司與上海津曼特生物科技有限公司訂立許可協議,以在中國內地開發、銷售、許諾銷售及商業化JSKN003,用於治療腫瘤相關適應症。目前,JSKN003在中國治療HER2-陽性乳腺癌(「BC」)、HER2-低表達BC和鉑耐藥複發性上皮性卵巢癌、原發性腹膜癌或輸卵管癌的三個III期臨牀試驗正在進行中。
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