Drug intelligence / Profile preview

HLX04 + oxaliplatin + fluoropyrimidine

Development stage
Unknown
Lead developer
Henlius
Modality
Nucleic Acid-Directed Small Molecules → Small Molecules, Monoclonal Antibodies → Antibody-Based Therapeutics, Covalent Small Molecules → Small Molecules, Classical Binding Small Molecules → Small Molecules
Administration
Intravenous, Oral
01

Overview

**HLX04 + oxaliplatin + fluoropyrimidine** is a combination regimen used primarily for the treatment of advanced and metastatic colorectal cancer, and being developed as a first-line therapy. HLX04 is a biosimilar of bevacizumab, a humanized monoclonal antibody that inhibits vascular endothelial growth factor A (VEGF-A), thereby reducing angiogenesis in tumors. Oxaliplatin is a platinum-based chemotherapy agent that induces cytotoxicity primarily via DNA crosslinking, leading to apoptosis in rapidly dividing cells. Fluoropyrimidine refers to chemotherapeutic agents such as 5-fluorouracil (5-FU), capecitabine (oral prodrug of 5-FU), or oral TS-1; these inhibit thymidylate synthase, interfering with DNA synthesis and cell division. The regimen is analogous to the widely used FOLFOX or CAPOX regimens but uses HLX04 as the VEGF inhibitor. HLX04 has demonstrated clinical equivalence to reference bevacizumab in efficacy and safety when combined with oxaliplatin-based regimens for metastatic colorectal cancer. HLX04 is developed and manufactured by Henlius[3][1][5]. Trials have involved use of XELOX (capecitabine/oxaliplatin) and mFOLFOX6 (fluorouracil/oxaliplatin)[3].

Other names
bevacizumab biosimilar + oxaliplatin + fluoropyrimidineHLX04 plus oxaliplatin plus fluoropyrimidineHLX-04 plus oxaliplatin plus fluoropyrimidineHLX 04 plus oxaliplatin plus fluoropyrimidine
02

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