君實生物(01877.HK):JS019注射液獲得藥物臨牀試驗申請受理通知書
格隆匯10月21日丨君實生物(01877.HK)公佈,近日,公司與北京恩瑞尼生物科技股份有限公司共同投資的蘇州科博瑞君生物醫藥科技有限公司收到國家藥品監督管理局核准簽發的《受理通知書》,JS019注射液的臨牀試驗申請獲得受理。
JS019注射液的活性成分為重組全人源抗CD39單克隆抗體。CD39為負責在腫瘤微環境中將免疫刺激性細胞外三磷酸腺苷(ATP)轉化為免疫抑制腺苷(ADO)的初始步驟的酶,並在腫瘤微環境免疫抑制反應中扮演着重要角色。研究表明,CD39在各種人類腫瘤中均呈現高表達現象,包括淋巴瘤、肉瘤、肺癌、胰腺癌、卵巢癌、腎細胞癌、甲狀腺癌和睾丸癌等。與直接靶向CD39酶活性的產品不同,JS019在工藝設計中增強了其抗體依賴的細胞毒作用(ADCC),可以直接靶向CD39高表達的腫瘤新生血管內皮細胞和腫瘤相關巨噬細胞(TAMs),從而用於治療晚期惡性腫瘤。JS019以該種高度選擇性的方式靶向腫瘤微環境中高表達的CD39,可在實現高藥效的同時,降低潛在的系統性副作用。
2020年9月,公司與北京恩瑞尼訂立合作協議,共同成立蘇州科博瑞君負責CD39藥物的研發、臨牀應用及商業化。公司及北京恩瑞尼分別擁有蘇州科博瑞君50%的權益,CD39項目直接或間接產生的利益將按雙方於蘇州科博瑞君的股權比例分派。
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