Mabwell Announces the U.S. FDA approval of 9MW3011 (FIC) for IND

SHANGHAI, in 2022 November 24 /PRNewswire/ — Mabwell (688062.SH), an innovative biopharmaceutical company with a full industry chain layout, announced that its clinical trial application for injection 9MW3011 for use in patients with polycythemia vera has been formally approved by the United States Food and Drug Administration. (FDA).

9MW3011 is a monoclonal antibody with a novel target. It was independently developed by the Mabwell Center for Innovation Research and Development San Diego, USA, in Category 1 Therapeutic Biologics. Because the target is mainly expressed on the surface of hepatocyte membranes, 9MW3011 can regulate hepatocyte-expressed hepcidin through specific binding, inhibit iron absorption and release, and reduce serum iron, thereby regulating iron homeostasis in vivo.

October month. NMPA accepted clinical trial application for 9MW3011 injection. The proposed indications for 9MW3011 include various diseases classified as rare in different regions of the world, such as β-thalassemia, polycythemia vera and other diseases related to iron homeostasis. There are still no mature and effective macromolecular drugs for the relevant indications. 9MW3011 is expected to qualify as an orphan drug in the future and become a first-in-class macromolecular drug that regulates iron homeostasis in vivo.

About Mabwell

Mabwell (688062.SH), an innovation-driven biopharmaceutical company, has a complete industrial chain of research and development, manufacturing and commercialization. We provide more effective and affordable therapies and innovative medicines to meet global medical needs. Since 2017 an advanced R&D system has been established, including target discovery, early discovery, drug suitability, preclinical, clinical research and manufacturing transformation. Mabwell has 14 different R&D-stage products based on a world-class and state-of-the-art R&D engine, including 10 new drug candidates and 4 biosimilars. We focus on the therapeutic areas of autoimmune diseases, oncology, metabolic disorders, ophthalmology and infectious diseases. Of these, 1 product has been released on the market, 2 have submitted a BLA, and 3 are in basic research. We have also implemented 1 national major scientific and technological special project “Important New Drug Development”, 2 National Key Research and Development Program Projects and several provincial and municipal science and technology innovation projects. Mabwell’s Taizhou factory has a strong in-house production capacity that meets international GMP standards regulated by NMPA, FDA and EMA, and has passed the EU QP audit. A large-scale production base located Shanghai is being built. Our mission is “Explore Life, Use Health” and our vision is “Innovation, from ideas to reality”. For more information, visit www.mabwell.com.

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Forward-looking statements

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 related to the Company’s product development, clinical trials, clinical and regulatory milestones and timelines. , market opportunity, competitive position, possible or implied future performance, business strategies, potential growth opportunities and other forward-looking statements. “Forward-looking statements” are statements that are not historical facts and involve numerous risks and uncertainties that could cause actual results to differ materially from any future results expressed or implied by the forward-looking statements. These statements may be identified by forward-looking statements, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “forecast,” “project” , “should”, “would” and similar expressions and negatives of those terms.

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Forward-looking statements are based on the Company’s current expectations and assumptions. Forward-looking statements are subject to a number of risks, uncertainties and other factors, many of which are beyond the Company’s control, including but not limited to: the environment; political; economy; society; legislation; our dependence on our product candidates, most of which are still in preclinical or various stages of clinical development; our reliance on third-party vendors, such as contract research organizations and contract manufacturing organizations; uncertainties inherent in clinical trials; our ability to conduct the necessary clinical trials for our product candidates and obtain regulatory approval of our product candidates; our ability to protect our intellectual property; potential impact of COVID-19; loss of any executive officers or key employees. If one or more of these risks or uncertainties materialize, or if certain assumptions are incorrect, actual results may differ materially from those indicated.

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The Company cautions all persons not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the applicable securities authority, to publicly update or revise any such statements to reflect any changes in expectations or events, conditions or circumstances on which such statements may be based. . , or could affect the likelihood that actual results will differ from those expressed in forward-looking statements. This statement is subject to all forward-looking descriptions, figures and assumptions contained in this press release.

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SOURCE Mabwell

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