On November 21, Maicompany announced that its independently developed 9MW3011 injection clinical trial application was officially approved by the US Food and Drug Administration (FDA), which can carry out clinical trials for patients with polycytosis.
9MW3011 is an innovative target monoclonal antibody independently developed by the San Diego Innovation and Research and Development Center located in the United States. It is a class 1 of biological products for treatment. Its target is mainly expressed on the surface of hepatocyte membrane. 9MW3011 can upregulate the level of iron modulin (Hepcidin) through specific binding, inhibit the absorption and release of iron, and reduce serum iron levels, thus regulating iron homeostasis in the body.
9MW3011's clinical trial application was accepted by the National Medical Products Administration (NMPA) last month. The indications are intended to include a variety of diseases listed as rare diseases in different regions of the world, such as β -thalassemia, polycythemia vera, and other diseases associated with iron homeostasis. Currently, there are no mature and effective macromolecular therapeutic drugs in the field of related indications, and therefore, 9MW3011 is expected to qualify as orphan drugs in the future and become the first macromolecular drug worldwide to regulate iron homeostasis in vivo.
