Shanghai Henlius Biotech, Inc. announced that, recently, application for clinical trial of HLX6018 (recombinant anti-GARP/TGF-b1 humanised monoclonal antibody injection) (HLX6018) independently developed by the Company was approved by the National Medical Products Administration. HLX6018 is an innovative anti-Garp/TGF-b1 complex monoclonal antibody independently developed by the Company, which is intended to be used for the treatment of fibrosis-related diseases. Glycoprotein A Repetitions Predominant (GARP) is a Type I transmembrane cell surface docking receptor for latent transforming growth factor-b1 (TGF-b1).

The complex formed by GARP binding with latent TGF-b1 triggers structural changes by binding with integrins or cleavage by thrombin, releasing mature TGF-b1. HLX6018 can inhibit the release of mature TGF-b1 by specifically binding to the GARP/TGF-b 1 complex, subsequently suppressing the TGF-b1-mediated activation, proliferation, and extracellular matrix secretion of fibroblasts to achieve the purpose of treating fibrosis-related diseases. Non-clinical studies have shown that HLX6018 has significant anti-pulmonary fibrosis and renal fibrosis effects and has a favorable safety profile.

As of the date of this announcement, no monoclonal antibody targeting GARP/TGF-1 has been approved for marketing globally.