Datailai (Cetuximab N01) 100mg Injection | China Biosimilar | GLT

Generic Information: Datailai (Cetuximab N01) — China Biosimilar

Datailai (达泰莱) is the brand name of cetuximab N01, a recombinant anti-EGFR chimeric monoclonal antibody developed and manufactured by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., a subsidiary of Kelun Pharmaceutical. Formerly known by its development code A140, cetuximab N01 was approved by the NMPA as a biosimilar to the originator cetuximab (Erbitux). It is Kelun-Biotech's third commercialized product and the first domestic cetuximab to complete a large-scale, head-to-head Phase III registration study against the originator in the first-line treatment of RAS wild-type metastatic colorectal cancer.

What Is Datailai (Cetuximab N01) Used For?

Datailai is approved for the first-line treatment of RAS wild-type metastatic colorectal cancer (mCRC), in combination with either the FOLFOX or FOLFIRI chemotherapy regimen. The approval rests on a randomized, double-blind, multi-center Phase III trial enrolling 688 patients that demonstrated clinical equivalence to the originator cetuximab in objective response rate, with no clinically meaningful difference in duration of response or progression-free survival. Datailai has also been included in China's national medical insurance drug list and recommended by the CSCO colorectal cancer guideline, making it an economical domestic alternative.

How Does Datailai (Cetuximab N01) Work?

Cetuximab N01 binds the extracellular domain of EGFR, blocking ligand binding and downstream oncogenic signaling, thereby inhibiting tumor cell proliferation, survival, invasion, and angiogenesis. As an IgG1 antibody, it also promotes receptor internalization to reduce EGFR expression and can trigger immune-mediated antitumor effects including ADCC, ADCP, and complement-dependent cytotoxicity. This dual mechanism — direct receptor blockade plus immune effector recruitment — mirrors the originator cetuximab, and the biosimilar was shown to be clinically equivalent in its registration program.

Indications

Datailai (cetuximab N01) is indicated for the first-line treatment of RAS wild-type metastatic colorectal cancer, in combination with FOLFOX or FOLFIRI. As with all EGFR inhibitors, a confirmatory RAS genetic test is required before treatment, since patients with RAS mutations do not benefit.

Dosage

Datailai is administered by intravenous infusion. It may be given every two weeks at 500 mg/m², or on a weekly schedule with an initial dose of 400 mg/m² followed by 250 mg/m² weekly. Premedication with an antihistamine and corticosteroid is recommended before the first infusion, and patients should be monitored during and after administration. The 100 mg/50 mL vial is the standard presentation.

Side Effects

The safety profile of Datailai is comparable to the originator cetuximab. Common adverse reactions include acneiform rash, infusion reactions, hypomagnesemia, diarrhea, nausea, and fatigue. The Phase III head-to-head study confirmed that safety, tolerability, and immunogenicity were similar between cetuximab N01 and the originator. Serum electrolytes, particularly magnesium, should be monitored during treatment, and patients should report any new or worsening skin or respiratory symptoms.

Storage

Store Datailai vials refrigerated at 2–8°C, protected from light. Do not freeze or shake. Use promptly after opening and discard any unused portion according to institutional policy.

Why Choose the GLT?

Datailai offers the clinical equivalence of the originator cetuximab at a markedly lower cost. It is included in China's national medical insurance drug list with a reimbursed price far below the United States wholesale price of the originator, where a single 100 mg Erbitux vial costs several times more than the reimbursed China price of cetuximab N01. Backed by a 688-patient head-to-head Phase III trial and a CSCO guideline recommendation, Datailai is a quality-assured, economical domestic option. Sourcing through a Hong Kong-licensed supplier such as GLT provides batch documentation and verified supply for institutions and patients.

How to Order Datailai (Cetuximab N01)

To order Datailai, 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 Datailai a biosimilar of Erbitux? Yes. Datailai (cetuximab N01) is a biosimilar to the originator cetuximab, approved based on a head-to-head Phase III trial demonstrating clinical equivalence.

Who makes Datailai? Datailai is developed and manufactured by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., a subsidiary of Kelun Pharmaceutical.

What is the difference between cetuximab N01 and cetuximab β? Cetuximab N01 (Datailai) is a biosimilar, while cetuximab β (Enlituo) is a Class 2.4 improved biologic with a modified glycan profile; both are domestic anti-EGFR antibodies but differ in regulatory class and manufacturing approach.

Is Datailai reimbursed in China? Yes. Datailai is included in China's national medical insurance drug list, improving affordability for eligible patients.