描述
Cetuximab NO1 Injection Description
Product name: Cetuximab N01 injection (Datelai/Kelun Botai)
Packaging specification: 100mg (50ml) ? Product dosage form: injection ? Packaging unit: bottle/box
Approval number: National Medicine Standard S20250006 ? Drug code: 86982635000030
Manufacturer: Sichuan Kelun Botai Biopharmaceutical Co., Ltd.
Cetuximab is a chimeric mouse–human IgG1 monoclonal antibody that competitively binds to the extracellular domain of the Epidermal Growth Factor Receptor (EGFR/HER1), blocking activation by EGF and TGF?? and inhibiting downstream proliferation and survival signaling (MAPK, PI3K/Akt, Jak/Stat)?it.wikipedia.org+8synapse.patsnap.com+8iiab.me+8. It also promotes receptor internalization, antitumor apoptosis, inhibits angiogenesis, and elicits antibody-dependent cellular cytotoxicity (ADCC)?
In China, Kelun Botai’s Cetuximab NO1 is approved for research use only (NMPA S20250006). It’s included in clinical phase III trials for:
-
RAS wild?type colorectal cancer (first-line)
-
Head and neck squamous cell carcinoma (with radiotherapy)
-
KRAS G12C-positive NSCLC?
Cetuximab NO1 Injection Product Specifications
Parameter | Details |
---|---|
Product Name | Cetuximab NO1 Injection (Datalai®) |
Strength | 100?mg cetuximab per 50?mL |
Formulation | IV infusion solution, sterile, preservative-free |
Manufacturer | Sichuan Kelun Botai Biopharma Co., Ltd. |
Approved For | NMPA S20250006 (research use) |
Product Code | 86982635000030 |
Storage Conditions | Store at 2–8?°C; protect from light; do not freeze |
Shelf Life | As labeled on packaging |
Appearance | Clear, colorless protein solution |
Administration | Intravenous infusion (research protocol only) |
Intended Use | Laboratory research / analytical purposes only |
Cetuximab NO1 Injection Mechanism & Research Applications
-
EGFR blockade: Prevents ligand-induced activation and downstream signaling (MAPK, PI3K/Akt)
-
Receptor internalization: Leads to EGFR downregulation on tumor cells?creativebiolabs.net+6pmc.ncbi.nlm.nih.gov+6synapse.patsnap.com+6.
-
ADCC: Recruits immune effectors to kill EGFR-expressing cancer cells?pmc.ncbi.nlm.nih.gov+1synapse.patsnap.com+1.
-
Combination synergy: Enhances chemo- or radio-therapy efficacy and overcomes resistance in KRAS wild-type models?.
Use cases in research:
-
KRAS wild-type colorectal cancer models
-
Head and neck carcinoma + radiotherapy studies
-
EGFR pathway signaling / resistance modeling
-
Testing in KRAS G12C and NSCLC models
Why Choose Cetuximab NO1 (Datalai)?
-
A locally produced biosimilar to Erbitux® with full regulatory traceability
-
Ideal for EGFR-pathway cancer research, ADCC assays, and combination therapy testing
-
Included in Phase III clinical pipelines for colorectal and lung cancer
-
Pre-filled injection format for reliable dosing in lab protocols
-
Panitumumab (EGFR antibody)
-
EGFR TKIs: Gefitinib, Erlotinib, Osimertinib
-
Radiolabeled EGFR tracers
-
Antibody–drug conjugates targeting EGFR
Summary
Cetuximab NO1 Injection (100?mg/50?mL) by Kelun Botai is a biosimilar EGFR antibody, approved for research in EGFR-driven cancers. It blocks receptor activation, mediates ADCC, and is crucial for preclinical oncology studies.
?? For laboratory research use only — not for human consumption or therapy.
JOHNEKA –
Pago recibido vía PayPal, gracias.