Mabwell (stock code: 688062.SH), an innovative biopharmaceutical company with the layout of the whole industrial chain, announced that the clinical trial application for the self-developed 9MW3011 Injection for β-thalassemia and polycythemia vera was accepted by the National Medical Products Administration (NMPA).

9MW3011 is monoclonal antibody with an innovative target. It is independently developed at San Diego Innovation and R&D Center of Mabwell in the United States, 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.

The proposed indications of 9MW3011 include a variety of diseases classified as rare in different regions of the world, such as β-thalassemia, polycythemia vera and other diseases related to iron homeostasis. At present, there are no mature and effective therapies or drugs for the relevant indications, so 9MW3011 is expected to be qualified as an orphan drug in the future and become the first macromolecular drug worldwide to regulate iron homeostasis in vivo.