先聲藥業(02096.HK):注射用SIM0237新適應症獲國家藥品監督管理局簽發藥物臨牀試驗批准通知書
格隆匯10月16日丨先聲藥業(02096.HK)公吿,於2023年10月15日,集團自主研發的抗PD-L1/IL-15雙特異性抗體注射用SIM0237新適應症獲中國國家藥品監督管理局(NMPA)簽發的藥物臨牀試驗批准通知書,擬用於非肌層浸潤性膀胱癌(NMIBC)患者。
SIM0237是基於集團自有蛋白質工程技術平台自主開發的一種抗PD-L1單抗與IL-15/IL-15Rαsushi融合蛋白,可通過結合PD-L1,阻斷PD1/PD-L1免疫抑制通路,同時通過IL-15啟動免疫系統,從而起到了解除免疫抑制和啟動免疫系統的雙重協同作用,發揮抗腫瘤作用。臨牀前研究顯示,SIM0237在小鼠腫瘤模型中藥效優於PD-L1單藥和IL-15單藥,有較高的臨牀開發潛力。
2022年10月27日、12月23日,SIM0237用於晚期實體瘤適應症的新藥臨牀試驗申請(IND)分別獲美國FDA及中國NMPA批准,目前正於中美兩地同步開展相關國際多中心臨牀試驗(MRCT)。
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