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

SHANGHAI,Nov. 24,2022 -- Mabwell (688062.SH),an innovative biopharmaceutical company with the layout of whole industry chain,announced that its clinical trial application for 9MW3011 Injection used in patients with polycythemia vera was formally approved by the United States Food and Drug Administration (FDA).

9MW3011 is monoclonal antibody with an innovative target. It is independently developed by Innovation R&D Center of Mabwell in San Diego,U.S.,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.

The clinical trial application for the 9MW3011 Injection has been accepted by NMPA in October. The proposed indications of 9MW3011 include a variety of 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 no mature and effective macromolecular drugs for the relevant indications so far. 9MW3011 is expected to be qualified as an orphan drug in the future and become the first-in-class macromolecular drug to regulate iron homeostasis in vivo.

About Mabwell

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 14 pipeline products in different R&D stages based on a world-class and state-of-the-art R&D engine,including 10 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 launched,2 BLA has been filed,3 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.

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