FDA Grants Fast Track Designation to 9MW3011

Release time:Sep 22, 2023

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

Fast Track is a process to facilitate the development and expedite the review of drugs to treat serious conditions. The purpose is to get important new drugs to the patient earlier. A drug that receives Fast Track Designation is eligible for Accelerated Approval and Priority Review if relevant criteria are met. 

9MW3011 has been approved to clinical study by NMPA and FDA, respectively. The first person has been dosed in the clinical study in China in March, 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.