Mabwell Announces the U.S. FDA approval of 9MW3811 for IND

SHANGHAI,June 15,2023 -- Mabwell (688062.SH),an innovative biopharmaceutical company with the entire value chain of the pharmaceutical industry,announced the clinical trial application of its self-developed 9MW3811 injection for idiopathic pulmonary fibrosis has been approved by the United States Food and Drug Administration (FDA). As China's First anti-IL-11 monoclonal antibody approved to clinical study,9MW3811 has received IND clearance in three countries (AUS,CN & USA).

9MW3811 is a humanized monoclonal antibody against human interleukin-11 (IL-11) independently developed by Mabwell. 9MW3811 can effectively block the activation of the downstream signaling pathway of IL-11 and inhibit the pathophysiological functions induced by IL-11,thereby achieving the therapeutic effect on fibrosis and tumor.

Preclinical study showed that 9MW3811 bound to IL-11 with high affinity,effectively blocked the activation of IL-11 signaling pathway,specifically regulated the interaction of tumor cells with T cells,macrophages,and tumor-associated fibroblasts,and thus enhanced the release of inflammatory cytokines in the tumor microenvironment,and increased the infiltration of T cells. Combination anti-tumor efficacy with anti-PD1 antibodies has been observed in a variety of solid tumor models. In preclinical studies of fibrotic diseases,9MW3811 significantly reduced the area of pulmonary fibrosis,reduced the content of lung collagen and improved lung function in mice with fibrosis,making it a promising therapeutic agent for idiopathic pulmonary fibrosis and other diseases.

9MW3811 is in dose escalation study in Australia and expected to have good safety profile according to existing data.

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 auto-immune diseases,oncology,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,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.

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