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君實生物(01877.HK):JS014注射液獲得藥物臨牀試驗批准通
格隆匯 08-31 19:59

格隆匯8月31日丨君實生物(01877.HK)公吿,公司收到中國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》,JS014注射液(項目代號JS014)的臨牀試驗申請獲得批准。

JS014注射液的活性成分為重組白介素21-抗人血清白蛋白(HSA)納米抗體融合蛋白,通過融合抗HSA的納米抗體使IL-21的半衰期得到顯著延長。該產品能以高親和力特異性地結合人IL-21R並激活淋巴細胞,半衰期的延長可以提高藥物在腫瘤微環境中的分佈,增強腫瘤微環境中浸潤淋巴細胞的活性,進而增強免疫系統殺傷腫瘤細胞的能力。此外,JS014與免疫檢查點單抗聯用體現出強大的協同抗腫瘤活性。

2019年6月,公司與Anwita Biosciences,Inc.簽署《許可協議》,公司獲得在大中華區(包括中國大陸、香港特別行政區、澳門特別行政區及台灣地區)開發及商業化創新IL-21融合蛋白JS014的權利。

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