Gelonghui, March 12, 丨 Fu Hong Han Lin (02696.HK) announced that recently, the clinical trial application for HLX6018 (recombinant anti-GARP/TGF-beta 1 anthropogenic monoclonal antibody injection) (“HLX6018”) independently developed by the company for the treatment of idiopathic pulmonary fibrosis was approved by the State Drug Administration.
HLX6018 is an innovative anti-GARP/TGF-beta1 complex monoclonal antibody independently developed by the company and intended for the treatment of fibrosis-related diseases. Glycoprotein A repetitionpredominant protein (GARP) is a type I transmembrane cell surface receptor for potential transforming growth factor-beta1 (TGF-beta1). The complex formed by binding GARP to potential TGF-β1 causes structural changes and releases mature TGF-β1 through binding to integrin or thrombin cleavage. HLX6018 can specifically bind to the GARP/TGF-beta1 complex, thereby inhibiting the release of mature TGF-β1, thereby inhibiting TGF-β1-mediated fibroblast activation, proliferation, and extracellular matrix secretion, to achieve the goal of treating fibrosis-related diseases. Non-clinical studies have shown that HLX6018 has significant anti-pulmonary fibrosis and renal fibrosis effects, and has good safety.
As of the announcement date, no monoclonal antibodies targeting the GARP/TGF-beta1 complex have been approved for marketing worldwide.