Mabwell (688062.SH), an innovative biopharmaceutical company with the layout of whole industry chain, announced that its IND application of 9MW3011 Injection for 1) iron overload in patients with β-thalassemia and 2) polycythemia vera has been approved by the National Medical Products Administration (NMPA). There are no mature and effective macromolecular drugs for the relevant indications so far. 9MW3011 has the potential to be designated as an orphan drug in the future and become the first-in-class macromolecular drug to regulate iron homeostasis in vivo.

9MW3011 is monoclonal antibody with an innovative target. It is independently developed by Innovation R&D Center of Mabwell in San Diego, U.S., belonging to Category 1 Therapeutic Biological Products. With its target mainly expressed on the surfaces of liver cell membranes, 9MW3011 can upregulate the level of hepcidin expressed by hepatocytes through specific binding, inhibit the absorption and release of iron, and lower the serum iron level, thus regulating the iron homeostasis in vivo.