Clinical-stage biotechnology company Delonix Bioworks announced on Friday that China's National Medical Products Administration (NMPA) has granted Investigational New Drug (IND) approval to the company's Group B meningococcal (MenB) vaccine candidate, DX-104.

This follows the successful completion of Clinical Trial Notification (CTN) procedures and ethics committee approval in Australia in January 2026. Delonix plans to initiate Phase I clinical trials in the near term to evaluate the safety and immunogenicity of DX-104 in human subjects.

DX-104 is an engineered MenB vaccine candidate developed using Delonix's proprietary OMV Plus platform. According to Delonix, the platform leverages precisely engineered outer membrane vesicles (OMVs) with intrinsic adjuvant properties to optimise immunogenicity. In preclinical studies, DX-104 induced robust serum bactericidal antibody (SBA) responses without the need for external adjuvants. Furthermore, DX-104 has achieved commercial-scale production with high batch-to-batch consistency, ensuring a reliable global supply chain as the candidate advances toward potential commercialisation.