By Fineline Cube United Laboratories International Holdings Ltd (HKG: 3933) announced that the National Medical Products Administration (NMPA) has approved a clinical study for its Category 1 drug candidate UBT251 to treat moderate‑to‑severe obstructive sleep apnea (OSA) comorbid with obesity. The long‑acting GLP‑1/GIP/GCG triple agonist, already in Phase II trials for obesity, type 2 diabetes, MASH, and chronic kidney disease, positions United Labs to address a critical unmet need in sleep‑disordered breathing.
Regulatory Milestone & Strategic Deal
| Item | Detail |
|---|---|
| Company | United Laboratories International Holdings Ltd (HKG: 3933) |
| Drug | UBT251 (GLP‑1/GIP/GCG triple agonist) |
| New Indication | Moderate‑to‑severe OSA with obesity |
| Regulatory Status | NMPA Phase I/II clinical study approved |
| Existing Approvals | Phase II for overweight/obesity, T2D, MASH, CKD (China) |
| Global Licensing Deal | USD 2 billion with Novo Nordisk (March 2025) |
| Territory Retained | China mainland, Hong Kong, Macau, Taiwan |
| Territory Licensed | Global ex‑China rights to Novo Nordisk |
Drug Profile & Mechanism
- Triple Agonist: Chemically synthesized peptide activating GLP‑1, GIP, and glucagon receptors to drive weight loss and metabolic improvements
- OSA Rationale: Weight reduction reduces airway obstruction; triple agonist mechanism may provide superior efficacy vs. GLP‑1 alone
- Market Need: 100‑150 million adults in China have OSA; 50% are obese; no approved pharmacotherapy addresses both conditions
Market Impact & Commercial Outlook
- OSA Market Opportunity: China OSA therapeutics market valued at ¥15 billion : (~US$2.1 billion) in 2025; pharmacotherapy segment growing at 20% CAGR
- Novo Partnership Validation: $2 B deal underscores global potential; United Labs retains high‑value China rights for all indications
- Revenue Potential: Analysts project ¥3–5 billion : (US$420–700 million) peak China sales for UBT251 across obesity/OSA/T2D indications by 2030
- Clinical Timeline: Phase I/II OSA trial initiation expected Q2 2026; data readout could support global Phase III under Novo’s leadership
- Strategic Value: Positions United Labs as a leader in metabolic‑respiratory comorbidities; validates triple agonist platform beyond diabetes
Forward‑Looking Statements
This brief contains forward‑looking statements regarding clinical development timelines, regulatory pathways, and revenue projections for UBT251. Actual results may differ due to clinical trial outcomes, competitive dynamics, and NMPA review processes.-Fineline Info & Tech