思路迪医药股份(01244):恩维达®联合GEMOX一线治疗晚期胆道癌III期研究结果在2026年ASCO年会正式发布

智通财经
May 27

智通财经APP讯,思路迪医药股份(01244)发布公告,本公司创新免疫新药恩维达®(恩沃利单抗注射液)的一项III期关键性临床研究成果,成功在2026年美国临床肿瘤学会(ASCO)年会上正式发布。

恩维达®是全球首个上市的皮下注射PD-L1抑制剂,由本公司与康宁杰瑞生物制药(9966.HK)联合开发,全球首个单域抗体用于治疗肿瘤,给药便捷、安全性优异,已在中国获批上市四年,中国累计销售超过20亿元人民币。美国、日本、欧洲权益在积极洽谈中。晚期胆管癌预后差、临床治疗手段有限,未满足临床需求巨大,本次III期研究数据的公开,将进一步验证本品在肝胆肿瘤领域的临床价值,进一步拓展中国市场销售适应症。该研究为一项前瞻性、随机、阳性药平行对照、开放标签的全国多中心III期关键性试验,聚焦中国晚期胆管癌患者一线治疗,旨在评估恩沃利单抗联合吉西他滨+奥沙利铂(GEMOX)方案相较单纯GEMOX方案的疗效与安全性,作为全球首个皮下注射的PD-L1单抗+GEMOX的靶免联合方案一线治疗BTC取得预期的生存获益优势的大型注册临床试验,直接为中国的临床实践指南提供高级别的循证医学依据,有助于改善中国BTC免疫联合治疗的策略,具有重大的科学意义和临床价值。

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