Mabwell (688062.SH), an innovative biopharmaceutical company with entire industrial chain, announced first patient dosing in the U.S. for a phase II study of the novel anti-TMPRSS6 antibody (R&D code: 9MW3011/DISC-3405) initiated by its partner DISC Medicine. This marks the successful achievement of the phase II study milestone in the collaboration.

This open-label, multicenter, within-participant dose escalation study of DISC-3405 will assess the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of DISC-3405 in participants with polycythemia vera (PV). Previous Phase I clinical data presented at the 2025 European Hematology Association (EHA) Congress demonstrated that DISC-3405 resulted in deep reductions in serum iron that were sustained and support a once-monthly SC dosing regimen. It also exhibited good safety profile.

9MW3011 stands as the only anti-TMPRSS6 monoclonal antibody candidate worldwide for PV patients. In contrast to exogenous hepcidin mimetics, 9MW3011 mediates iron homeostasis through physiological upregulation of endogenous hepcidin expression, potentially yielding more biologically congruent regulatory outcomes. It has been granted Fast Track Designation (FTD) and Orphan Drug Designation (ODD) by US FDA, and 3 Phase 1b clinical trials are ongoing in China.