Mabwell Announces FDA Fast Track Designation to 9MW3011
Friday, September 22, 2023
Mabwell has announced that the FDA has granted Fast Track Designation (FTD) to their drug, 9MW3011, for the treatment of patients with polycythaemia vera (PV).
9MW3011 has also received approval for clinical study by both the National Medical Products Administration (NMPA) in China and the FDA in the United States. In March 2023, the first person was dosed in the clinical study conducted in China.
9MW3011 is an anti-TMPRSS6 antibody that was developed at the San Diego Innovation and R&D Centre of Mabwell. It works by upregulating the level of hepcidin expressed by hepatocytes through specific binding. This action inhibits the absorption and release of iron and lowers serum iron levels, thus regulating iron homoeostasis in the body.
The drug's proposed indications include β-thalassaemia and polycythaemia vera, both of which are conditions related to abnormal blood cell production and iron metabolism. Currently, there are no mature and effective macromolecular drugs available for these indications.
In terms of commercialisation, Mabwell has granted exclusive rights to develop and commercialise 9MW3011 in the United States, Europe, and other territories, excluding Greater China and Southeast Asia.
