Drug intelligence / Profile preview

hlx01

Development stage
Phase 4
Lead developer
Henlius
Modality
IgG Antibodies → Naked Antibodies → Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

HLX01 is a biosimilar of rituximab, developed by Shanghai Henlius Biotech. It is a chimeric monoclonal antibody targeting the CD20 antigen on B lymphocytes. By binding to CD20, HLX01 induces B-cell lysis through mechanisms such as complement-dependent cytotoxicity and antibody-dependent cell-mediated cytotoxicity. The drug was the first biosimilar approved in China and is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma, previously untreated stages III-IV follicular non-Hodgkin’s lymphoma, CD20-positive diffuse large B-cell non-Hodgkin’s lymphoma (DLBCL), and has also been studied for rheumatoid arthritis in combination with methotrexate[1][3][5][6]. Clinical studies have demonstrated that HLX01 has comparable efficacy and safety to reference rituximab products in these indications.

Brand names
HanliKang
Other names
rituximab biosimilarHLX01 (rituximab injection)
02

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