Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a China-based biopharmaceutical company, has announced that it has received Fast Track Designation (FTD) from the US Food and Drug Administration (FDA) for its drug candidate 9MW3011 (MWTX-003/DISC-3405) for the treatment of patients with polycythemia vera (PV). This designation underscores the potential impact of 9MW3011 in addressing the unmet medical needs of PV patients.
9MW3011: A Novel Anti-TMPRSS6 Antibody
9MW3011 is an anti-TMPRSS6 antibody developed at Mabwell’s San Diego Innovation and R&D Center. The molecule is designed to upregulate the level of hepcidin expressed by hepatocytes through specific binding, which inhibits the absorption and release of iron, thereby lowering serum iron levels and regulating iron homeostasis in vivo. The proposed indications for 9MW3011 include β-thalassemia and polycythemia vera, conditions for which there are currently no mature and effective biologic drugs available.
Global Partnership and Commercialization Rights
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 South-East Asia. This partnership highlights the global potential of 9MW3011 and the commitment to bringing innovative treatments to patients worldwide. The deal involves total potential combined upfront and milestone payments to Mabwell of USD 412.5 million, along with royalties on future net sales, reflecting the significant investment in the development and commercialization of this drug candidate.
Conclusion
The Fast Track Designation from the US FDA for 9MW3011 is a significant milestone for Mabwell Bioscience, recognizing the drug’s potential to improve the lives of patients with polycythemia vera. With a strategic partnership in place and a promising pipeline, Mabwell is well-positioned to advance the development of 9MW3011 and contribute to the field of iron homeostasis disorders.-Fineline Info & Tech
