Enlituo (Cetuximab β) 100mg Injection | China Anti-EGFR mAb | GLT

Generic Information: Enlituo (Cetuximab β) — China Modified Biologic

Enlituo (恩立妥) is a domestically developed anti-EGFR monoclonal antibody approved in China under the generic name cetuximab β. It is manufactured by Taizhou Mabtech Pharmaceutical Co., Ltd., a wholly owned subsidiary of Mabpharm, and was granted marketing approval by the NMPA as a Class 2.4 improved biologic. What sets cetuximab β apart from the originator is its manufacturing process: it is produced in a Chinese hamster ovary (CHO) expression system with a humanized glycan profile that removes the non-human glycosylation responsible for many severe hypersensitivity reactions. This page covers the single vial strength of 100 mg/10 mL.

What Is Enlituo (Cetuximab β) Used For?

Enlituo is approved for the first-line treatment of RAS/BRAF wild-type metastatic colorectal cancer (mCRC) in combination with the FOLFIRI chemotherapy regimen. This is the setting where its registration study demonstrated efficacy comparable to the originator cetuximab, while showing a lower incidence of Grade 3 or higher infusion reactions, skin reactions, and electrolyte disturbances. The drug fills a long-standing gap as the first domestically developed anti-EGFR monoclonal antibody for colorectal cancer, ending nearly two decades in which the imported originator was the only option in this class.

How Does Enlituo (Cetuximab β) Work?

Cetuximab β binds the extracellular domain of EGFR, blocking ligand binding and the downstream signaling pathways that drive tumor cell proliferation, survival, and angiogenesis. The key difference from the originator is the engineered glycan profile: by removing the non-human α-1,3-galactose and other non-human sugar residues, the antibody reduces the risk of pre-existing IgE-mediated hypersensitivity and severe infusion reactions. This gives cetuximab β a safety advantage while retaining the same anti-EGFR mechanism and clinical benefit.

Indications

Enlituo (cetuximab β) is indicated for the first-line treatment of RAS/BRAF wild-type metastatic colorectal cancer, in combination with FOLFIRI. Patient selection requires confirmatory genetic testing for RAS and BRAF status before starting treatment.

Dosage

Enlituo is given by intravenous infusion on a weekly schedule. The initial dose is 400 mg/m² infused over 120 minutes, followed by weekly maintenance doses of 250 mg/m² over 60 minutes. As with other cetuximab products, premedication with an antihistamine and corticosteroid is given before the first infusion, and patients are monitored during and after administration. The 100 mg/10 mL vial is the standard presentation for dose preparation.

Side Effects

The most common adverse reactions are skin-related, including acneiform rash, dry skin, and pruritus, along with infusion reactions, hypomagnesemia, and diarrhea. A distinguishing feature of cetuximab β is its reduced incidence of severe infusion reactions and hypersensitivity compared with the originator, owing to its humanized glycosylation. Routine monitoring of serum electrolytes, especially magnesium, is recommended throughout treatment.

Storage

Store Enlituo vials refrigerated at 2–8°C, protected from light, and do not freeze. Once opened, use the solution promptly and discard any unused portion per institutional policy.

Why Choose the GLT?

Enlituo is included in China's national medical insurance drug list with a reimbursed price that is substantially lower than the Western list price of the originator cetuximab. In the United States, a comparable 100 mg vial of originator Erbitux carries a wholesale cost several times higher than the reimbursed China price of cetuximab β. For patients and institutions seeking an anti-EGFR monoclonal antibody with a reduced hypersensitivity profile at a more accessible cost, sourcing Enlituo through a Hong Kong-licensed supplier such as GLT is a practical, dependable choice, complete with batch documentation and verified supply.

How to Order Enlituo (Cetuximab β)

To order Enlituo, contact our team on WhatsApp at +86 15234153837 or by email at [email protected]. Please share the required quantity and your destination country so we can confirm availability, documentation, and delivery terms.

FAQ

Is Enlituo a biosimilar of Erbitux? No. Enlituo is a Class 2.4 improved biologic (cetuximab β), not a biosimilar; it has the same anti-EGFR mechanism but a modified, humanized glycan profile that lowers hypersensitivity risk.

Who makes Enlituo? Enlituo is manufactured by Taizhou Mabtech Pharmaceutical Co., Ltd., a wholly owned subsidiary of Mabpharm.

What is the difference between cetuximab β and cetuximab? Cetuximab β is produced in CHO cells with a humanized glycosylation that reduces severe infusion reactions, whereas the originator cetuximab carries non-human sugar residues.

Is Enlituo reimbursed in China? Yes. Enlituo is included in China's national medical insurance drug list, making it more affordable for eligible patients.