Mabwell (688062.SH), an innovative biopharmaceutical company with the layout of whole industry chain, announced that the clinical trial application for its independently developed 9MW3811 was formally accepted by National Medical Products Administration (NMPA) for indications of advanced malignancies and idiopathic pulmonary fibrosis.

9MW3811 is a humanized monoclonal antibody against human interleukin-11 (IL-11) independently developed by Mabwell, belonging to Category 1 Therapeutic Biological Products. 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. It is the first monoclonal antibody product that launched into a clinical trial of the same target worldwide.

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 specific pulmonary fibrosis and other diseases.

The clinical trial application of 9MW3811 was approved by Australian Therapeutic Goods Agency (TGA) in February 2023, and the corresponding clinical trial has been initiated.