Mabwell (stock code: 688062.SH), an innovative biopharmaceutical company with the layout of the whole industry chain, announced today that the IND application for the self-developed 6MW3511 injection has been formally approved by the Center for Drug Evaluation (CDE) of China National Medical Products Administration for clinical trial in advanced solid tumor.

6MW3511 is a bifunctional group drug protein independently constructed by Mabwell using humanized anti-PD-L1 nanobodies to link to TGF-β RII mutants. The mutant design facilitates the maintenance of whole-molecule stability and reduces degradation of the natural TGF-β group during the manufacture process and in vivo. By blocking PD-1/PD-L1 and TGF-β/TGF-β-R dual pathways simultaneously, and with the excellent local tumor penetrability resulting from the concise structure, 6MW3511 is expected to further address the difficult problem of immunosuppression in the tumor microenvironment. The results of preclinical studies showed that 6MW3511 injection had good in vivo anti-tumor efficacy and good tolerability in animals.