By Fineline Cube 
United Laboratories International Holdings Ltd (HKG: 3933) announced that the U.S. Food and Drug Administration (FDA) has approved a clinical study for its Category 1 drug candidate TUL108, a broad‑spectrum β‑lactamase inhibitor targeting infections caused by carbapenem‑resistant Gram‑negative bacteria.
Regulatory Milestone & Drug Profile
| Item | Detail |
|---|---|
| Company | United Laboratories International Holdings Ltd (HKG: 3933) |
| Drug | TUL108 (Category 1) |
| Mechanism | Broad‑spectrum β‑lactamase inhibitor |
| FDA Approval | Phase IIa clinical trial authorization |
| Combination | With meropenem |
| Key Efficacy | High sensitivity against carbapenem‑resistant E. coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Acinetobacter baumannii |
| Indications | Complicated urinary tract infections (cUTI), complicated intra‑abdominal infections (cIAI), lung infections, bloodstream infections |
| Strategic Value | Full coverage against carbapenem‑resistant Gram‑negative bacteria, addressing urgent clinical need |
Clinical Rationale & Market Need
- Carbapenem Resistance: CRE infections represent a critical public health threat, with mortality rates up to 50% and limited treatment options
- Current Therapies: Existing combinations (e.g., ceftazidime‑avibactam, meropenem‑vaborbactam) have gaps in coverage, particularly against CRAB and CRPA
- TUL108 Advantage: Demonstrates full coverage across major carbapenem‑resistant pathogens, potentially offering a universal β‑lactamase inhibitor solution
- Combination Synergy: With meropenem, restores activity against KPC, NDM, VIM, IMP, and OXA‑48 carbapenemases
Market Impact & Commercial Outlook
- Global CRE Market: Valued at $900 million : in 2025, projected to exceed $1.5 billion : by 2030 driven by rising resistance rates
- Revenue Potential: Analysts project ¥3–5 billion (US$420–700 million) peak annual sales for TUL108 in China if approved, based on mandatory use in CRE infections
- Strategic Positioning: Positions United Labs as a leader in antibiotic resistance innovation, competing with Pfizer, Merck, and Shionogi
- Regulatory Pathway: FDA approval enables global development; Category 1 status in China supports priority NMPA review
- Next Steps: Phase IIa trial initiation expected Q2 2026; potential for breakthrough therapy designation based on unmet need
Forward‑Looking Statements
This brief contains forward‑looking statements regarding clinical development timelines, regulatory pathways, and revenue projections for TUL108. Actual results may differ due to clinical trial outcomes, competitive dynamics, and FDA/NMPA review processes.-Fineline Info & Tech