Last reviewed 2026-06-03 · How we verify

Nimotuzumab Injection

Nimotuzumab Injection is a EGFR inhibitor monoclonal antibody Small molecule drug developed by Biotech Pharmaceutical Co., Ltd.. It is currently FDA-approved for Head and neck squamous cell carcinoma, Non-small cell lung cancer, Nasopharyngeal carcinoma. Also known as: Taixinsheng, Nimotuzumab.

Nimotuzumab is a humanized monoclonal antibody that blocks the epidermal growth factor receptor (EGFR) to inhibit tumor cell proliferation and survival.

Nimotuzumab Injection is an epidermal growth factor receptor erbB1 inhibitor, classified as an INHIBITOR drug modality. It is used to treat various types of cancer, including esophageal cancer, uterine cervical neoplasms, cervical squamous cell carcinoma, gastric cancer, and is being studied in combination with other treatments for advanced esophageal squamous cell carcinoma.

At a glance

Mechanism of action

Nimotuzumab binds to EGFR on cancer cells, preventing ligand-induced activation and downstream signaling through the PI3K/Akt and MAPK/ERK pathways. This leads to reduced cell proliferation, increased apoptosis, and enhanced radiosensitivity in EGFR-expressing tumors. Unlike some other anti-EGFR antibodies, nimotuzumab has a lower incidence of severe skin toxicity due to its lower binding affinity for EGFR.

Approved indications

• Head and neck squamous cell carcinoma
• Non-small cell lung cancer
• Nasopharyngeal carcinoma

Common side effects

• Acneiform rash
• Infusion reactions
• Hypomagnesemia
• Diarrhea
• Nausea

Key clinical trials

• Postoperative Radiotherapy Combined With Nimotuzumab Followed by Bemcentinib in High-Risk Patients With Head and Neck Squamous Cell Carcinoma (PHASE3)
• HRS-4642 in Combination With Nimotuzumab and Chemotherapy for BRPC With KRAS G12D Mutation (PHASE2)
• Nimotuzumab Combined With Toripalimab and Chemotherapy for Locally Advanced Tonsillar Cancer (PHASE2)
• Compare Radiotherapy Plus Nimotuzumab Versus Radiotherapy Alone in Platinum-ineligible Patients With Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (PHASE3)
• Clinical Study of Carbon Ion Radiotherapy for Pancreatic Cancer. (NA)
• Nimotuzumab in Combined With Chemotherapy for Treatment of IVB Stage,Rrecurrent or Persistent Cervical Carcinoma (PHASE3)
• Nimotuzumab High-risk, Locally Advanced Squamous Cell Carcinoma of the Cervix (PHASE2)
• Neoadjuvant Nimotuzumab Plus Gemcitabine and Carboplatin in Unresectable Stage III Squamous Cell Lung Carcinoma (PHASE2)

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Nimotuzumab Injection CI brief — competitive landscape report
• Nimotuzumab Injection updates RSS · CI watch RSS
• Biotech Pharmaceutical Co., Ltd. portfolio CI

Frequently asked questions about Nimotuzumab Injection

Related

• Drug class: All EGFR inhibitor monoclonal antibody drugs
• Target: All drugs targeting EGFR (Epidermal Growth Factor Receptor)
• Manufacturer: Biotech Pharmaceutical Co., Ltd. — full pipeline
• Therapeutic area: All drugs in Oncology
• Indication: Drugs for Head and neck squamous cell carcinoma
• Indication: Drugs for Non-small cell lung cancer
• Indication: Drugs for Nasopharyngeal carcinoma
• Also known as: Taixinsheng, Nimotuzumab

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing