FDA Grants Fast Track Designation to 9MW3011
SHANGHAI,Sept. 22,2023 -- Mabwell (688062.SH),an innovative biopharmaceutical company with entire industry chain,announced that FDA has granted Fast Track Designation (FTD) to 9MW3011 (R&D code in the US: MWTX-003/DISC-3405) for the treatment of patients with polycythemia vera (PV).
Fast Track is a process to facilitate the development and expedite the review of drugs to treat serious conditions. The purpose is to get important new drugs to the patient earlier. A drug that receivesFast Track Designation is eligible forAccelerated Approval and Priority Review if relevant criteria are met.
9MW3011 has been approved to clinical study by NMPA and FDA,respectively. The first person has been dosed in the clinical study in China in March,2023.
About 9MW3011
9MW3011 is an anti-TMPRSS6 antibody developed at San Diego Innovation and R&D Center of Mabwell. 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 proposed indications of 9MW3011 include β-thalassemia and polycythemia vera. At present,there are no mature and effective macromolecular drug for relevant indications.
Mabwell has granted DISC Medicine,INC. (NASDAQ：IRON) exclusive rights to develop and commercialize 9MW3011 in the United States,Europe,and other territories excluding Great China and Southeast Asia. Mabwell will obtain a total of up to $412.5 million of down payment and milestone payments,as well as royalties on net sales.
About Mabwell
Mabwell (688062.SH) is an innovation-driven biopharmaceutical company with the entire value chain of the pharmaceutical industry. 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 oncology,auto-immune diseases,metabolic disorders,ophthalmologic diseases and infectious diseases,etc. Of these,2 products have been approved and commercialized,1 product has been filed for MA approval,1 product is in the preparation of filing,2 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.
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