Erbitux® is the commercial brand name of cetuximab, a chimeric mouse-human monoclonal antibody targeting epidermal growth factor receptor (EGFR) developed by Merck KGaA. It binds specifically to EGFR to block ligand-induced receptor activation, inhibiting tumour cell proliferation, invasion and metastasis. Enlituo® is a domestic improved biologic, namely Cetuximab Beta Injection. Although sharing the identical amino acid sequence with cetuximab, it is produced in CHO cells with optimized glycosylation profile.
Main Indications
In combination with FOLFIRI regimen for first-line treatment of metastatic colorectal cancer in adult patients with RAS/BRAF wild-type tumours.
Clinical Research
Phase 3 clinical studies demonstrated that Cetuximab Beta combined with FOLFIRI significantly improves objective response rate and prolongs progression-free survival in RAS/BRAF wild-type metastatic colorectal cancer patients. Compared with reference cetuximab, Cetuximab Beta has lower levels of Gal-α-1,3-Gal glycosylation, which reduces the risk of severe hypersensitivity reactions.
Common Side Effects
Systemic reactions: infusion-related reactions, hypomagnesemia;
Common mild adverse reactions: acneiform rash, pruritus, dry skin, diarrhoea. Rare but severe: severe hypersensitivity reactions, cardiopulmonary arrest, interstitial lung disease.
Approval Status in China
Original drug Erbitux® (Cetuximab Injection) was approved for marketing in China. The domestic improved biologic Enlituo® (Cetuximab Beta Injection) was officially approved for marketing in China in 2024, with the specification of 100mg(10ml) per vial. It is currently a prescription anti-tumour monoclonal antibody drug.
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