Mabwell (688062.SH), an innovative biopharmaceutical company with the layout of whole industry chain, launched first in human clinical trial of its iron homeostasis regulating macromolecular drug 9MW3011.

The study (CTR20230046) is a phase 1, single center, randomized, double-blind, placebo-controlled, ascending dose study to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamics and immunogenicity of 9MW3011 in healthy adult participants.

9MW3011 is monoclonal antibody with an innovative target. It is independently developed at San Diego Innovation and R&D Center of Mabwell in the United States, belonging to Category 1 Therapeutic Biological Products. With its target mainly expressed on the surfaces of liver cell membranes, 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.

9MW3011 has been approved to clinical study both in China and the US. The proposed indications of 9MW3011 include β-thalassemia and polycythemia vera. At present, there are no mature and effective therapies or drugs for the relevant indications, so 9MW3011 is expected to be qualified as an orphan drug in the future and become the first-in-class macromolecular drug worldwide to regulate iron homeostasis in vivo.