Delonix Bioworks, a clinical-stage biotechnology company focused on next-generation bacterial vaccines, has received Investigational New Drug (IND) clearance from China’s National Medical Products Administration (NMPA) for its Group B meningococcal (MenB) vaccine candidate, DX-104.

The clearance follows successful completion of Clinical Trial Notification (CTN) procedures and ethics committee approval in Australia in January 2026. With regulatory approvals now secured in both China and Australia, the company plans to initiate Phase I clinical trials to evaluate the safety and immunogenicity of DX-104 in human subjects.

Qiubin Lin, CEO and Founder of Delonix Bioworks, said the dual regulatory clearances mark a significant milestone as the company transitions into a clinical-stage organisation. He added that DX-104 forms a key part of Delonix’s global strategy to develop scalable, highly immunogenic and well-tolerated engineered bacterial vaccines to address unmet medical needs worldwide.

Invasive Meningococcal Disease (IMD) is a severe and potentially fatal bacterial infection that primarily affects infants, adolescents and young adults. Serogroup B accounts for nearly 50 percent of global IMD cases and continues to show rising prevalence. Although existing vaccines such as GSK’s Bexsero and Pfizer’s Trumenba have demonstrated strong clinical and commercial success with Bexsero generating approximately USD 1.58 billion in sales in 2025—gaps in global access and strain coverage persist.

DX-104 has been developed using Delonix’s proprietary OMV Plus platform, which utilises precisely engineered Outer Membrane Vesicles (OMVs) with intrinsic adjuvant properties to enhance immune response. In preclinical studies, the candidate generated strong Serum Bactericidal Antibody (SBA) responses without requiring external adjuvants. The company also reported successful commercial-scale manufacturing with consistent batch quality, supporting readiness for broader clinical and future commercial development.