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Mabwell Biologics (688062.
SH), an innovative biopharmaceutical company with a full industry chain layout, announced that its clinical trial application for self-developed 9MW3011 injection has been officially approved by the US Food and Drug Administration (FDA), which can conduct clinical trials
for patients with polycythemia vera.
9MW3011 is an innovative target monoclonal antibody independently developed by Mabwell's San Diego Innovation R&D Center in the United States, which is a class
1 therapeutic biological product.
Its target is mainly expressed on the surface of hepatocyte membrane, and 9MW3011 can regulate the level of hepcidin expression in hepatocytes through specific binding, inhibit the absorption and release of iron, and reduce serum iron levels, thereby regulating iron homeostasis
in vivo.
The clinical trial application for 9MW3011 was accepted
by the National Medical Products Administration (NMPA) last month.
Indications are intended to include a variety of diseases classified as rare diseases in different parts of the world, such as β-thalassemia, polycythemia vera and other diseases associated with iron homeostasis
.
At present, there are no mature and effective macromolecular therapeutics in the field of related indications, so 9MW3011 is expected to obtain orphan drug status in the future and become the world's first macromolecular drug
to regulate iron homeostasis in the body.