君實生物(01877.HK):JS001sc 注射液獲得藥物臨牀試驗批准通知書
格隆匯3月7日丨君實生物(01877.HK)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 注射液(項目代號"JS001sc")的臨牀試驗申請獲得批准。由於藥品的研發週期長、審批環節多,容易受到一些不確定性因素的影響,敬請廣大投資者謹慎決策,注意防範投資風險。
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 與配體 PD-L1 和 PD-L2 的結合,從而活化 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表明,JS001sc 通過皮下注射給藥在動物模型中表現出顯着的抑瘤作用,在 0.3mg/kg的劑量水平下,皮下注射給藥的 JS001sc 與靜脈注射給藥的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,更短時間的皮下注射給藥具有更大的吸引力。同時皮下注射可避免因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,截至本公吿披露日,全球範圍內已上市的十餘種PD-(L)1 抗體中,僅恩沃利單抗注射液(商品名:恩維達®)為皮下注射給藥,其餘產品均為靜脈注射給藥。
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