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君實生物(688180.SH):JS001sc注射液用於晚期鼻咽癌治療的臨牀試驗獲批

格隆匯3月7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》JS001sc注射(項目代號“JS001sc”)的臨牀試驗申請獲得批准

根據《中華人民共和國藥品管理法》及有關規定,經審查,2021年12月22日受理的JS001sc注射液符合藥品註冊的有關要求,同意開展用於晚期鼻咽癌治療的臨牀試驗。

JS001sc注射液是公司在已上市產品特瑞普利單抗注射液(商品名:拓益®產品代號:JS001)的基礎上開發的皮下注射製劑。JS001sc以人PD-1為靶點高親和力結合PD-1,選擇性阻斷PD-1配體PD-L1PD-L2的結合,從而活T淋巴細胞,提高淋巴細胞的增殖及細胞因子的分泌。臨牀前體內藥效試驗明,JS001sc通過皮下注射給藥在動物模型中表現顯著的抑瘤作用0.3mg/kg的劑量水平,皮下注射給藥JS001sc與靜脈注射給藥特瑞普利單抗抑瘤作用相當,未見顯著差異。此外,動物對JS001sc的耐受性良好

隨着腫瘤免疫治療“慢病化管理”的理念逐步普及,相比於頻繁前往醫院進行數小時的靜脈注射,短時間的皮下注射給藥具有更的吸引力。同時皮下注射可避免靜脈注射給藥方式造成的輸注相關不良反應,使患者整體獲益,並減少醫療成本經查詢公開信息,截至公吿披露日,全球範圍內已上市的十餘種PD-(L)1 抗體中,恩沃利單抗注射液(商品名:恩維達®)為皮下注射給藥產品均為靜脈注射給藥

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