China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that its clinical filing for the Category 1 drug candidate 9MW3011 in β-Thalassemia and polycythemia vera has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step forward in the development of innovative treatments for these rare diseases.
Drug Profile and Mechanism
9MW3011 is a monoclonal antibody (mAb) developed at Mabwell’s research and development (R&D) center in San Diego, USA. The drug can regulate the level of Hepcidin expression in hepatocytes, inhibit the absorption and release of iron, reduce serum iron levels, and regulate iron homeostasis in vivo through specific binding to the target, which is mainly expressed on the surface of liver cell membranes.
Development and Future Potential
9MW3011 is under development to treat multiple rare diseases, including β-Thalassemia, polycythemia vera, and other conditions related to iron homeostasis, for which there are currently no effective treatments or drugs. The drug is expected to obtain orphan drug designation (ODD) status and become the first macromolecular drug to regulate iron homeostasis globally.
Future Outlook
The acceptance of the clinical filing for 9MW3011 by the NMPA underscores Mabwell Bioscience’s commitment to advancing innovative therapies for rare diseases. This development highlights the potential of 9MW3011 to address significant unmet medical needs and improve outcomes for patients with iron homeostasis disorders.-Fineline Info & Tech
