MABWELL (SHANGHAI) BIOSCIENCE CO. LTD. (688062.SH), an innovative biopharmaceutical company with a full industrial chain layout, announced that the U.S. FDA has granted orphan drug to the iron homeostasis macromolecule regulatory drug 9MW3011 (R&D code in the U.S.: MWTX-003/DISC-3405) (Orphan Drug Designation, ODD). 9MW3011 is indicated for the treatment of polycythemia vera (PV).

Orphan drug designation from the FDA applies to drugs for rare diseases that affect fewer than 200,000 patients in the United States. Orphan drug designation can bring policy benefits to drug developers, including assistance during the drug development, clinical fee reductions, and seven years of market exclusivity after approval.

9MW3011 has been undergoing clinical trial in China and the United States and received FDA fast track designation in September last year.

About 9MW3011

9MW3011 is an anti-TMPRSS6 monoclonal antibody independently developed by MABWELL's San Diego Innovation R&D Center in the United States. It can upregulate the level of hepcidin expressed in hepatocytes and inhibit the absorption and release of iron by specifically binding to the target, reducing serum iron levels, thereby regulating iron homeostasis in the body. Indications are intended to include a variety of diseases classified as rare diseases in different regions around the world, such as β-thalassemia, polycythemia vera and other diseases related to iron homeostasis. At present, there are no mature and effective macromolecule therapeutic drugs in the field of relevant indications.

MABWELL has granted DISC MEDICINE, INC. (NASDAQ: IRON) 9MW3011 exclusive rights to develop, manufacture and commercialize and otherwise exploit 9MW3011 in all regions except China and Southeast Asia. MABWELL can receive a total of up to $412.5 million in upfront payments and milestone payments, as well as royalties based on net sales after the product is launched.
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