智通财经APP讯，先声药业(02096)发布公告，本集团自主研发的创新融合蛋白 SIM0237(PD-L1/IL15v双特异性抗体)于2026年欧洲泌尿外科学会年会(EAU 2026)公布用于治疗卡介苗(BCG)无应答高危非肌层浸润性膀胱癌(NMIBC)的I/II 期临床研究数据。
截至数据截止日(2025年11月28日)，共有49名患者接受SIM0237单药膀胱灌注治疗。在伴原位癌(CIS)且至少完成一次基线后肿瘤评估的患者中，80%的患者达到完全缓解(CR)。在仅伴乳头状病变的患者中，12个月无病生存率(DFS)为 65.8%。整体结果显示SIM0237在BCG无应答高危NMIBC患者中展现出具有前景的临床疗效信号。
安全性方面，SIM0237膀胱灌注给药显示出良好的安全性及耐受性，且血清样本分析未检测到药物的系统性暴露。
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