Mabwell Launched First in human Clinical Trial of Its Iron Homeostasis Regulating Macromolecular Drug 9MW3011
SHANGHAI, March 14, 2023 /PRNewswire/ -- 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 ?-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.
Mabwell (688062.SH), an innovation-driven biopharmaceutical company, has the whole industrial chain of R&D, manufacturing, and commercialization. We provide more effective and accessible therapy and innovative medicines to fulfill global medical needs. Since 2017, an advanced R&D system which covers target discovery, early discovery, druggability, preclinical, clinical research and manufacturing transformation was established. Mabwell has 17 pipeline products in different R&D stages based on a world-class and state-of-the-art R&D engine, including 13 novel drug candidates and 4 biosimilars. We focus on the therapeutic areas of auto-immune diseases, oncology, metabolic disorders, ophthalmologic diseases and infectious diseases, etc. Of these, 1 product has been approved and commercialized, 2 products have been filed for MA approval, 3 products are in pivotal trials. We have also undertaken 1 national major scientific and technological special project for "Significant New Drugs Development", 2 projects for National Key R&D Programmes, and several provincial and municipal science and technological innovation projects. Mabwell's Taizhou factory possesses robust in-house manufacturing capability compliant with international GMP standards regulated by the NMPA, FDA and EMA, and has passed the EU QP Audit. The large-scale manufacturing base located in Shanghai is under construction. Our mission is "Explore Life, Benefit Health" and our vision is "Innovation, from ideas to reality". For more information, please visit www.mabwell.com.
This press release contains forward-looking statements including, but not limited to, the potential safety, efficacy, regulatory review or approval and commercial success of our product candidates and those relating to the Company's product development, clinical studies, clinical and regulatory milestones and timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. "Forward-looking statements" are statements that are not historical facts and involve a number of risks and uncertainties, which may cause actual results to be materially different from any future results expressed or implied in the forward-looking statements. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "should," "would," and similar expressions and the negatives of those terms.
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