康方生物(09926.HK)與Summit訂立許可協議的修訂 以擴大許可地區
格隆匯6月3日丨康方生物(09926.HK)公吿，於2024年6月3日，公司與Summit訂立許可協議的修訂，據此，公司與Summit同意擴大許可協議項下的許可地區。經擴大許可地區包括(i)中美洲，(ii)南美洲，(iii)中東地區及(iv)非洲。經擴大Summit許可地區將新增至許可協議項下的許可地區，因此，經修訂許可地區包括原有Summit許可地區及經擴大Summit許可地區。
根據許可協議修訂，公司可獲得7000萬美元的首付款和里程碑款，以及經擴大Summit許可地區的銷售提成(提成比例與許可協議的比例一致)。公司將繼續為包括經擴大Summit許可地區在內的許可地區供應依沃西，並獲得供貨收入。同時，在許可協議修訂中，雙方進一步強化了包括臨牀試驗數據、上市申報文件在內的成果的跨地區共享合作條款，以加速依沃西在全球各地區的監管註冊及商業化工作。Summit將新增獲得在中美洲、南美洲、中東地區和非洲相關市場開發依沃西的獨家權益。同時，Summit將繼續負責包括經擴大Summit許可地區在內的許可地區的臨牀開發、產品註冊及商業化，以及所有相關費用。
據悉，依達方(依沃西)是公司自主研發的全球首創PD-1/VEGF雙特異性腫瘤免疫治療藥物。依達方於2024年5月24日獲得中國國家藥品監督管理局批准上市，用於治療經EGFRTKI治療後進展的局部晚期或轉移性非鱗狀非小細胞肺癌(nsq-NSCLC）患者，成為全球首個商業化PD-1/VEGF雙特異性抗體藥物。除了在中國獲批的第一個適應症外，公司目前正在五項III期臨牀研究中評估依沃西，其中包括兩項國際多中心臨牀研究及四項以PD-1抑制劑為陽性對照藥物的註冊研究。依沃西現有涵蓋消化道腫瘤、肝細胞癌、結直腸癌等共16個適應症的臨牀試驗正在進行中。
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