君實生物(688180.SH)：抗CD112R單克隆抗體注射液臨牀試驗申請獲得FDA批准
格隆匯4月5日丨君實生物(688180.SH)公佈，近日，上海君實生物醫藥科技股份有限公司全資子公司 TopAlliance Biosciences, Inc.收到美國食品藥品監督管理局(簡稱“FDA”)的通知，抗CD112R單克隆抗體注射液(項目代號“TAB009/JS009”)用於治療晚期實體瘤的臨牀試驗申請獲得FDA批准。
TAB009/JS009是公司獨立自主研發的靶向CD112R的重組人源化IgG4單克隆抗體，用於晚期惡性腫瘤的治療。CD112R又名PVRIG(脊髓灰質炎病毒受體相關免疫球蛋白結構域)，是公司發現的全新免疫檢查點通路，公司執行董事、副總經理、核心技術人員SHENGYAO(姚盛)博士為該全新通路的發現人之一。
CD112R是PVR家族的一個單跨膜蛋白，主要表達於T細胞和NK細胞上，並在細胞激活後有明顯的表達上調。CD112R與TIGIT的共同配體CD112表達於抗原遞呈細胞和部分腫瘤細胞表面，CD112R與配體結合後可抑制T細胞和NK細胞的抗腫瘤作用。TAB009/JS009能以高親和力特異性地結合CD112R，有效阻斷CD112R與其配體CD112信號通路，進而促進T細胞和NK細胞的活化和增殖，增強免疫系統殺傷腫瘤細胞的能力。
截至公吿披露日，國內外尚無靶向CD112R的產品獲批上市。
TIGIT是PVR家族的另一個免疫抑制靶點，其配體有PVR和CD112，且其結合CD112的位點不同於CD112R。TAB009/JS009可與TIGIT抗體協同作用，以促進T細胞活化。臨牀前體內藥效實驗顯示，TAB009/JS009與公司自主研發的特異性抗TIGIT單克隆抗體注射液(項目代號“TAB006/JS006”)聯合治療，表現出顯著的協同抗腫瘤作用。截至公吿披露日，TAB006/JS006的臨牀試驗申請已獲得國家藥品監督管理局和FDA的批准。
此外，TAB009/JS009與TAB006/JS006及公司商業化產品特瑞普利單抗注射液(商品名：拓益®，產品代號：JS001)聯用，可進一步促進T細胞活化，改善臨牀治療效果。公司將積極探索聯合用藥，以最大程度地發揮自主研發產品的協同抗腫瘤作用。
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