Exclusive Summary

• First-in-class MoA with robust safety: The world's first HSA-fused long-acting IL-7 in clinical stage, showing no risk of cytokine storm and an extended half-life of up to 98 hours in Phase Ia.
• Best-in-class efficacy potential: Demonstrated a 100% responder rate (CD4+ T cell increase >100/μL) at medium/high doses, sustained through Day 55, outperforming main competitors in its class.
• Tackling a massive unmet 'Missing Link': Addresses the completely untapped market of T-cell restoration for HIV INRs and broader lymphopenia, projecting a multi-billion dollar 'blue ocean' similar to historically successful anemia/neutropenia drugs.
• FDA regulatory endorsement: Granted US FDA Orphan Drug Designation (ODD) for Idiopathic CD4+ T lymphocytopenia (ICL), with a clear and derisked regulatory pathway validated by recent FDA precedents.

Asset Materials

Contact Us for Full Materials