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君實生物(688180.SH):用於晚期惡性腫瘤治療的JS007注射液獲批臨牀試驗
格隆匯 06-04 16:10

格隆匯6月4日丨君實生物(688180.SH)公佈,近日,公司收到國家藥品監督管理局核准簽發的《藥物臨牀試驗批准通知書》,JS007注射液(項目代號“JS007”)的臨牀試驗申請獲得批准

JS007是公司自主研發的重組人源化抗CTLA-4單克隆抗體注射液,主要用於晚期惡性腫瘤的治療。細胞毒性T淋巴細胞抗原-4(Cytotoxic T lymphocyte-associated antigen-4CTLA-4)是T細胞表面調節免疫應答的一個重要受體。JS007可以特異性地與CTLA-4結合並有效阻斷CTLA-4其配體B7(CD80CD86)的相互作用,從而活化T淋巴細胞,抑制腫瘤生長前同靶點國外已上市藥物ipilimumab作為首個免疫檢查點抑制劑在黑色素瘤、淋巴瘤、腎細胞癌、尿路上皮癌、卵巢癌和非小細胞肺癌等多個瘤種中被證實具有顯著的抑癌作用,並獲批治療晚期黑色素瘤。臨牀前研究資料顯示,JS007與同靶點但具有不同序列的ipilimumab相比具有相似的安全性,但有更好的藥效。

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