Policy & Regulation
Mabwell launches first 9MW3011 in human clinical trial
15 March 2023 -

Mabwell (688062.SH), a China-based biopharmaceutical company, announced on Tuesday that it has introduced the first in human clinical trial of its iron homeostasis regulating macromolecular drug 9MW3011.

The study, CTR20230046, a phase one, single centre, randomised, double-blind placebo-controlled, ascending dose study, is intended to assess the safety, tolerability, pharmacokinetic, pharmacodynamics and immunogenicity of 9MW3011 in healthy adult subjects.

The product, a monoclonal antibody with an innovative target, has been independently developed at Mabwell's San Diego Innovation and R&D Center in the United States. It belongs to Category one Therapeutic Biological Products. Its target is mainly expressed on the surfaces of liver cell membranes and can upregulate the level of hepcidin expressed by hepatocytes via specific binding, inhibit the absorption and release of iron, and reduce the serum iron level, thus regulating the iron homeostasis in vivo. It has been approved for clinical study both in China and the United States.