Ruiji Biologics, a wholly owned subsidiary of China- based Rhegen, has had its freeze-dried bivalent human metapneumovirus (hMPV) mRNA vaccine (CXSL2600842, Class 1.1 preventive biologic) accepted for IND review by China's Centre for Drug Evaluation (CDE), marking the first domestically originated hMPV mRNA vaccine to reach clinical filing globally while no approved hMPV vaccine exists.

The asset leverages Rhegen's fully integrated mRNA platform spanning antigen design, synthetic modification, lipid nanoparticle delivery, and freeze-dried formulation, with the lyophilised format enabling 2 to 8 degree Celsius storage and circumventing ultra-cold supply chains that constrain rival mRNA products in tropical and resource-limited markets.

The filing is not a standalone event but the second anchor of Rhegen's pan-respiratory combination strategy, sitting alongside its freeze-dried bivalent RSV mRNA vaccine (CXSL2400860) already in Phase I; the stated endpoint is a combinable RSV plus hMPV multivalent mRNA vaccine. Globally, the RSV/hMPV combination lane is contested by Moderna's mRNA-1365 and AstraZeneca's USD 1.1 billion Icosavax acquisition (IVX-A12), but no hMPV-only or hMPV-leading mRNA candidate has yet matched Rhegen's IND milestone, giving the Chinese company a defensible first-mover position in a disease area with high co-infection burden in paediatrics, geriatrics, and immunocompromised cohorts.