【复宏汉霖(02696.HK):汉斯状®(斯鲁利单抗注射液)联合化疗一线治疗广泛期小细胞肺癌(ES-SCLC)的日本桥接

智通财经
24 Jun
【复宏汉霖(02696.HK):汉斯状®(斯鲁利单抗注射液)联合化疗一线治疗广泛期小细胞肺癌(ES-SCLC)的日本桥接试验完成首例患者给药】智通财经APP讯,复宏汉霖(02696.HK)发布公告,近日,一项在日本一线治疗广泛期小细胞肺癌(ES-SCLC)患者中开展的汉斯状®(斯鲁利单抗注射液)(汉斯状®)联合化疗(卡铂-依托泊苷)的桥接试验已完成首例患者给药。本次试验系公司依据日本药品医疗器械综合机构(PMDA)的2期临床试验默示许可开展的桥接试验,用于支持未来汉斯状®于日本的上市申报。此前,一项比较汉斯状®或安慰剂联合化疗(卡铂-依托泊苷)在一线治疗广泛期小细胞肺癌 (ES-SCLC)患者中开展的国际多中心3期临床试验已于2021年12月达到了总生存期(OS)的主要研究终点。

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