Exclusive Summary

• Potential Best-in-Class Long-Acting IL-1R1 Antagonist: Utilizes IgG4 Fc fusion technology to significantly extend half-life and enhance affinity (3-13x higher than wild-type in vitro) compared to existing therapies.
• Superior Patient Compliance: Addresses the critical unmet need in CAPS and Gouty Arthritis for reduced dosing frequency. Unlike the standard of care (e.g., Anakinra) requiring daily injections, UB338 offers a more convenient dosing regimen.
• Optimized Safety Profile: Engineered to eliminate ADCC and CDC effector functions to prevent unwanted cell depletion, supported by a clean preclinical toxicology package with a high safety margin (MTD ≥ 300 mg/kg).
• Solid Global IP Protection: Patents already granted in key markets including China, Japan, and Australia, with PCT applications entering the national stage, securing commercial rights globally.
• Prime Partnering Asset: Currently at the Pre-IND stage with a comprehensive preclinical package (efficacy, toxicology, CMC) ready for rapid regulatory filing, making it an ideal asset for licensing to bolster autoimmune/rare disease pipelines.

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