科倫藥業(002422.SZ):創新藥物KL-A289注射液獲臨牀試驗通知書
格隆匯 8 月 4日丨科倫藥業(002422.SZ)公佈,公司於近日獲悉,公司控股子公司四川科倫博泰生物醫藥股份有限公司與安源醫藥科技(上海)有限公司(以下簡稱"安源醫藥")共同開發的創新腫瘤免疫藥物KL-A289注射液獲得國家藥品監督管理局臨牀試驗通知書。
據悉,KL-A289注射液是公司與安源醫藥共同開發的具有自主知識產權的新一代腫瘤免疫檢查點抑制劑,作用機制相對明確,可解除對抗腫瘤T細胞的抑制,增強機體對腫瘤的免疫應答,擬用於晚期實體瘤的治療。臨牀前研究表明KL-A289注射液在腫瘤動物模型中單藥表現出抗腫瘤活性,且具有與其他免疫檢查點抑制劑、化療藥物等聯合用藥的潛力,藥代動力學特徵良好,兼具良好的安全性和耐受性。
經查詢,全球尚無同靶點藥物獲批上市。
截至目前,公司在KL-A289注射液項目上已投入研發費用約2252萬元人民幣。公司將按照國家藥品監督管理局簽發的臨牀試驗通知書的要求,組織實施KL-A289注射液的臨牀試驗。
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