FDA Grants Orphan Drug Designation to 9MW3011

Release time:Feb 18, 2024

Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that FDA has granted Orphan Drug Designation (ODD) to 9MW3011 (R&D code in the US: MWTX-003/DISC-3405) for the treatment of patients with polycythemia vera (PV).  

FDA Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States. Orphan Drug status provides benefits to drug developers, including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and seven years of post-approval marketing exclusivity. 

Clinical trials of 9MW3011 are ongoing in China and the US, respectively. FDA has granted Fast Track Designation (FTD) to 9MW3011 in September, 2023.

About 9MW3011

9MW3011 is an anti-TMPRSS6 antibody developed at San Diego Innovation and R&D Center of Mabwell. 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. The proposed indications of 9MW3011 include β-thalassemia and polycythemia vera. At present, there are no mature and effective macromolecular drug for relevant indications.

Mabwell has granted DISC Medicine, INC. (NASDAQ:IRON) exclusive rights to develop and commercialize 9MW3011 in the United States, Europe, and other territories excluding Great China and Southeast Asia. Mabwell will obtain a total of up to $412.5 million of down payment and milestone payments, as well as royalties on net sales.