Description
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 |
| Strength | 100mg cetuximab per 50mL |
| 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 (100mg/50mL) 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.



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