By Fineline Cube China – based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study assessing its Category 1 drug candidate 9MW3011 for the treatment of β – thalassemia and polycythemia vera. The drug, which already obtained clinical trial approval for polycythemia vera in the US in November last year, is poised to advance its development in both domestic and international markets.
Drug Mechanism and Development
9MW3011 is a monoclonal antibody (mAb) developed at Mabwell’s research and development (R&D) center in San Diego, California. The drug is designed to regulate hepcidin expression in hepatocytes, inhibit iron absorption and release, and reduce serum iron levels by specifically binding to a target expressed on liver cell membranes. This mechanism allows 9MW3011 to modulate iron homeostasis in the body, addressing the underlying pathology of several rare diseases related to iron metabolism.
Target Indications and Future Prospects
9MW3011 is currently in development for multiple rare diseases, including β – thalassemia, polycythemia vera, and other conditions related to iron homeostasis. These diseases often lack effective treatments or approved drugs, highlighting the significant unmet medical need that 9MW3011 aims to address. Mabwell expects the drug to obtain orphan drug designation (ODD) status, positioning it as the first macromolecular drug to regulate iron homeostasis globally. The NMPA’s approval marks a crucial step forward in bringing this innovative therapy closer to patients in need.-Fineline Info & Tech