By Fineline Cube 
Shanghai Shenlian Biomedical Co., Ltd. (Shenlian Bio, SHA: 688098) announced that its licensed innovative drug, UB‑221 injection, has entered Phase 2 clinical testing and has now fully enrolled 145 participants.
About UB‑221
- Mechanism – A subcutaneously administered, humanized anti‑IgE monoclonal antibody developed by United Biomedical, Inc. (UBI).
- Development Partners – United Biomedical is the second‑largest shareholder of Shenlian Bio; Yangzhou Shizhiyuan Biotechnology Co., Ltd. (a Shenlian affiliate) holds all Chinese rights to marketing, R&D, production, and sales.
- Indication – Designed to target chronic spontaneous urticaria (CSU), a debilitating allergic skin disorder with limited therapeutic options.
Phase 2 Study Design
- Population – 145 adults with moderate‑to‑severe CSU who have inadequate response to standard antihistamines.
- Dosing Regimen – Subcutaneous UB‑221 every four weeks for 24 weeks, with optional dose‑escalation arm.
- Endpoints – Primary: Reduction in Urticaria Activity Score (UAS7) compared to baseline; Secondary: safety profile, time to symptom control, and quality‑of‑life metrics.
Strategic Implications
- Portfolio Expansion – The trial marks a new therapeutic avenue for Shenlian Bio beyond its established anti‑TNF and anti‑IL‑6 programs.
- Market Opportunity – CSU affects ~1–2% of the global population; a successful Phase 2 outcome could position UB‑221 as a first‑in‑class treatment in East Asia and beyond.
- Collaborative Edge – Leveraging UBI’s global IP and Yangzhou Shizhiyuan’s manufacturing infrastructure strengthens the pathway to regulatory approval and commercialization.
Next Steps
Shenlian Bio plans to complete data collection by Q4 2025, followed by a pivotal Phase 3 trial if efficacy and safety milestones are met. The company will also engage with Chinese health authorities to discuss accelerated review pathways.-Fineline Info & Tech