BioNxt Solutions(BioNxt Solutions)为MS(MS)推进其亚语言Cladribine方案, 以2026年在关键制造步骤和2025年猪研究后进行的人类试验为对象。 BioNxt Solutions advances its sublingual cladribine program for MS, targeting a 2026 human trial after key manufacturing steps and a 2025 pig study.

生物Nxt解决方案公司已推进其多发性硬化症的亚舌性克拉迪宾计划 (BNT23001),完成了向其欧洲CDMO转移关键制造和分析方法. BioNxt Solutions Inc. has advanced its sublingual cladribine program (BNT23001) for multiple sclerosis, completing key manufacturing and analytical method transfers to its European CDMO. 已经订购了活性药物成分,正在运往临床级薄膜产品试点批量生产途中。 The active pharmaceutical ingredient has been ordered and is en route for pilot batch production of clinical-grade thin-film products. 该公司正在优化2025年10月开始的猪生物利用率研究之前的流程,这是验证吸收和剂量的关键前期步骤。 The company is optimizing processes ahead of a pig bioavailability study beginning in October 2025, a critical preclinical step to validate absorption and dosing. 在顺利完成这项研究之后,计划于2026年初进行人类第一次试点研究。 A first-in-human pilot study is planned for early 2026, following successful completion of this study. 重新拟订的目的是改善生物利用率和病人对传统口服形式的坚持程度。 The reformulation aims to improve bioavailability and patient adherence over traditional oral forms. 该公司继续寻求加速美国专利审查和全球知识产权保护。 The company continues to pursue accelerated U.S. patent review and global intellectual property protection.