乐普生物(02157.HK):CMG901(AZD0901)全球III期临床试验CLARITY-GASTRIC01取得积极顶线结果

智通财经
Jul 28
【乐普生物(02157.HK):CMG901(AZD0901)全球III期临床试验CLARITY-GASTRIC01取得积极顶线结果】智通财经APP讯,乐普生物(02157.HK)发布公告,有关集团与AstraZeneca AB(AstraZeneca,一家全球生物制药公司)就抗体偶联药物(ADC)候选药物CMG901(sonesitatug vedotin,亦称为AZD0901)合作的最新情况。于2023年2月,KYM Biosciences Inc.(KYM,一家由公司与康诺亚生物医药科技有限公司(康诺亚)成立的合营企业)与AstraZeneca已订立全球独家许可协议,以开发及商业化CMG901(公司与康诺亚通过KYM共同开发的候选药物)。截至本公告日期,CLARITY-Gastric01全球III期临床试验公布的积极顶线结果显示,与研究者选择的治疗方案相比,sonesitatug vedotin在二线及后线(2L+) Claudin 18.2阳性晚期胃癌患者中展现出具有统计学显著性且极具临床意义的总生存期(OS)改善。该试验纳入了局部晚期或转移性胃癌、胃食管结合部(GEJ)癌或食管腺癌(EAC)患者,入组标准为在任意染色强度下至少25%的肿瘤细胞表达 Claudin 18.2(CLDN18.2)。在美国、欧盟、中国和日本,每年约有18.35万名患者因CLDN18.2阳性、HER2阴性的晚期或转移性胃癌╱胃食管结合部癌接受2L+治疗。

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