智通财经APP讯，华昊中天医药-B(02563)发布公告，本集团的重要海外管线之一，优替德隆胶囊(UTD2)联合卡培他滨和奥沙利铂一线治疗PD-L1阴性的局部晚期或转移性胃或胃食管交界处腺癌(该联合疗法)的国际多中心II/III期注册临床研究(BG02-2404)已获得美国食品药品管理局(FDA)的批准。
本集团利用特有的合成生物学技术平台开发的UTD2已顺利完成美国I期临床研究，其安全性和疗效得到充分验证。截至本公告日期，优替德隆在针对胃癌的临床研究中展现出优异的数据：在一项已完成的优替德隆联合PD-1和奥沙利铂一线治疗不可切除的局部晚期或复发╱转移HER2阴性胃癌的临床II期研究中，共计23例患者完成疗效评估，其中15例实现部分缓解，8例实现疾病稳定，客观缓解率达到65.2%，临床获益率达到100%。UTD2也因此获得了FDA授予的治疗晚期胃癌孤儿药资格认定。
相较于难以开发成口服剂型的紫杉类药物，优替德隆不易被P-糖蛋白泵出胞外，具有口服给药的优势。UTD2将显著提升患者用药便利性和依从性，有助于长期的辅助和维持治疗，减轻患者治疗成本，展现巨大的应用潜力和市场空间。BG02-2404是本公司针对UTD2开展的首个国际多中心II/III期注册临床研究，旨在进一步夯实本公司国际化开发战略的实施。
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