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. Datailai® is its domestic biosimilar product, namely Cetuximab N01 Injection.
Main Indications
In combination with FOLFIRI or FOLFOX regimen for first-line treatment of metastatic colorectal cancer in adult patients with RAS wild-type tumours.
Clinical Research
Phase 3 clinical studies demonstrated that Cetuximab N01 has comparable efficacy, pharmacokinetic profile and safety to the reference product Erbitux®. When combined with chemotherapy, it achieves equivalent objective response rate, progression-free survival and duration of response in patients with RAS wild-type metastatic colorectal cancer. The clinical development referenced pivotal trial data of Erbitux®.
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 biosimilar drug Datailai® (Cetuximab N01 Injection) was officially approved for marketing in China in 2024, with the specification of 100mg(50ml) per vial. It is currently a prescription anti-tumour monoclonal antibody drug.
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