China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced receiving approval to conduct a clinical study assessing its Category 1 drug candidate 9MW3011 in polycythemia vera. The drug’s clinical trial filing was accepted for review in China last month, marking a significant step forward in its development.
Drug Profile
9MW3011 is a monoclonal antibody (mAb) developed at Mabwell’s research and development (R&D) center in San Diego, California, USA. The drug regulates the level of hepcidin expression in hepatocytes, inhibits iron absorption and release, reduces serum iron levels, and regulates iron homeostasis in vivo through specific binding to the target expressed on liver cell membranes.
Development and Future Implications
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. This clinical study approval positions Mabwell to advance its innovative therapeutic approach and address significant unmet medical needs.-Fineline Info & Tech
