HLX15-IV

HLX15-IV is a fully human anti-CD38 IgG1κ monoclonal antibody developed as a biosimilar to daratumumab (marketed as Darzalex and Darzalex Faspro). It is independently developed by Shanghai Henlius Biotech. The drug targets CD38, a cell surface protein highly expressed on multiple myeloma cells. By binding to CD38, HLX15 induces tumor cell lysis and apoptosis through mechanisms including complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC), and antibody-dependent cellular phagocytosis (ADCP). It also reduces immunosuppressive cells in the tumor microenvironment. The primary indication under development for HLX15-IV is multiple myeloma, particularly in patients who are ineligible for autologous stem cell transplantation. Clinical studies have demonstrated pharmacokinetic similarity and comparable safety/immunogenicity profiles to reference daratumumab[2][5][8].

Brand names

HLX15-IVHLX-15-IVHLX 15-IV

Other names

daratumumab biosimilar HLX15recombinant anti-CD38 fully human monoclonal antibody injection