Esco Aster 和 Shine-On Biomedical 获得了 FDA 批准的一款首创外泌体药物，目前处于一期临床试验阶段。 Esco Aster and Shine-On Biomedical secured FDA approval for a first-in-class exosome drug, now in Phase I trials.

Esco Aster是一家设在新加坡的CRDMO公司,它与Shine-On Bio Medicine达成了临床的CGMP制造协议,以推进一个针对HLA-G的一流Exoposome药物平台。 Esco Aster, a Singapore-based CRDMO, has secured a clinical cGMP manufacturing agreement with Shine-On Biomedical to advance a first-in-class exosome drug platform targeting HLA-G. 自2023年以来积极开展的合作支持Shine-On(Shine-On)在2025年初成功地批准其牵头候选人SOB100(SOB100)进入第一阶段试验。 The collaboration, active since 2023, supported Shine-On’s successful U.S. FDA IND approval in early 2025 for its lead candidate, SOB100, now in Phase I trials. 该平台显示了提供治疗分子的前景,并取得了积极的临床前期生物分布结果。 The platform shows promise in delivering therapeutic molecules, with positive preclinical biodistribution results. Esco Aster 的 3D Tide MotionTM 生物反应器使得高效的体外生产成为可能,该公司继续进行探索性装载研究。 Esco Aster’s 3D Tide Motion™ bioreactor enables efficient exosome production, and the company continues exploratory loading studies. 这一伙伴关系还支持整个东盟的自主细胞疗法方案和亚太区域更广泛的生物制造努力。 The partnership also supports autologous cell therapy programs across ASEAN and broader biomanufacturing efforts in the Asia-Pacific region.