Mabwell (688062.SH), a China-based biopharmaceutical company, announced on Thursday that it has received Fast Track Designation (FTD) from the US FDA for 9MW3011 (R&D code in the US: MWTX-003/DISC-3405) intended for the treatment of patients with polycythemia vera (PV), a blood thickening condition that can cause clots.

9MW3011 has received approval for clinical study by the Chinese regulator NMPA and the US FDA, respectively.

A clinical study in China dosed its first subject with 9MW3011 in March 2023. The product is an anti-TMPRSS6 antibody developed at Mabwell's San Diego Innovation and R&D Center. The company said that 9MW3011 can upregulate the level of hepcidin expressed by hepatocytes through specific binding, inhibit the absorption and release of iron, and lower the serum iron level, thus regulating the iron homeostasis in vivo.

Mabwell has granted DISC Medicine, INC. (NASDAQ: IRON) exclusive rights to develop and commercialise 9MW3011 in the United States, Europe, and other territories excluding Great China and Southeast Asia. Mabwell will obtain a total of up to USD412.5 million of down payment and milestone payments, as well as royalties on net sales.