先聲藥業(02096.HK):國家藥監局簽發SIM0235藥物臨牀試驗批准通知書
格隆匯12月7日丨先聲藥業(02096.HK)發佈公吿,於2021年12月6日,集團自主研發的人源化抗腫瘤壞死因子2型受體(TNFR2)單克隆抗體SIM0235(SIM1811-03注射液)已獲得中國國家藥品監督管理局簽發的藥物臨牀試驗批准通知書,擬用於開展復發或難治性晚期實體瘤和皮膚T細胞淋巴瘤(CTCL)的臨牀試驗。
SIM0235是一種人免疫球蛋白G1(IgG1)型人源化抗TNFR2單克隆抗體。能夠特異性識別表達在細胞表面的TNFR2,通過抗體依賴性細胞介導的細胞毒作用(ADCC)、抗體依賴性細胞介導的吞噬作用(ADCP)等在內的Fc端功能,對高表達TNFR2的調節性T細胞(Treg)、骨髓來源抑制細胞(MDSC)等免疫抑制細胞發揮殺傷作用,同時還可以通過阻斷內源性腫瘤壞死因子(TNF)對TNFR2的激活作用,抑制TNFR2介導的免疫抑制功能及相關TNFR2+免疫抑制細胞Treg和MDSC的增殖,增強機體對腫瘤的殺傷免疫反應,發揮抗腫瘤作用。此外,SIM0235還能夠特異性識別表達在腫瘤細胞表面的TNFR2,通過抗體Fc端介導的效應功能直接殺傷高表達TNFR2的腫瘤細胞。
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