Delonix Bioworks announced that DX-104, its Group B meningococcal (MenB) vaccine candidate, has received clinical trial approval from the Center for Drug Evaluation (CDE) of China’s NMPA. The first engineered outer membrane vesicle (OMV) vaccine approved for clinical development in China will enter Phase I studies in Australia this quarter, leveraging global data generation to support international regulatory pathways.
Regulatory Milestone
Item
Detail
Company
Delonix Bioworks (Shanghai-based)
Agency
CDE/NMPA (China); TGA (Australia – approved Jan 2026)
Asset
DX-104 – Group B meningococcal (MenB) vaccine
Technology
Engineered OMV (outer membrane vesicle) vaccine
Platform
Proprietary OMV Plus™ technology
China Status
First engineered OMV vaccine approved for clinical trials
Global Status
Phase I Australia initiation (Q1 2026)
Technology Platform & Competitive Differentiation
Feature
DX-104 (Delonix)
Bexsero (GSK)
Strategic Advantage
Technology
Engineered OMV Plus™
Native OMV + recombinant proteins
Optimized immunogen presentation
Adjuvant Requirement
None required
Requires adjuvant
Enhanced safety profile; simplified manufacturing
Immune Response
Strong native OMV immunogenicity
Established efficacy
Potentially superior durability
Pyrogenic Reaction
Significantly lower than Bexsero
Baseline reactogenicity
Improved tolerability, especially in pediatric populations
Preclinical Evidence & Market Context
Parameter
DX-104 Performance
Benchmark (GSK Bexsero)
Implication
SBA Assays (international licensure endpoint)
Significant superiority vs. prevalent Chinese strains
Current standard
Potential for best-in-class efficacy in Asia-Pacific
Pyrogenicity
Significantly reduced
Higher baseline
Competitive safety advantage for pediatric and adolescent vaccination
Manufacturing
Adjuvant-free process
Complex multi-component formulation
Cost and scalability advantages
Market Reference: GSK’s Bexsero (only commercially available OMV-based MenB vaccine) generated USD 1.3 billion in 2024 sales, demonstrating strong commercial traction and market growth potential for next-generation MenB vaccines.
Unmet Need: MenB causes 50% of meningococcal disease globally with high mortality/morbidity; current vaccine coverage remains limited due to cost, reactogenicity, and strain coverage gaps.
Strategic Positioning & Development Roadway
Priority
Execution Plan
Timeline
Phase I Australia
Safety and immunogenicity in healthy adults
Q1-Q4 2026
Global Development
Leverage Australia data for US/EU IND submissions
2026-2027
Strategic Partnerships
Explore Big Pharma licensing for ex-China commercialization
Data-dependent
China Registration
Parallel Phase I/II development pathway
Post-Australia data
First-Mover China Advantage: As the first engineered OMV vaccine approved by CDE, DX-104 positions Delonix for domestic market leadership and government procurement preference under China’s vaccine self-sufficiency initiatives.
OMV Platform Validation: DX-104 success validates Delonix’s OMV Plus™ platform for rapid pandemic response and multivalent vaccine development (e.g., OMV-based COVID-19, influenza candidates).
Forward‑Looking Statements This brief contains forward‑looking statements regarding DX-104 clinical development timelines, superiority to Bexsero in Phase I/II trials, and Delonix Bioworks’ partnership and commercialization strategy. Actual results may differ due to immunogenicity variability in human studies, competitive responses from GSK and Pfizer (MenB vaccines), and global regulatory requirements for novel OMV engineering.-Fineline Info & Tech
By Fineline Cube