Last reviewed · How we verify
Cetuximab Solution for infusion
Cetuximab Solution for infusion is a Small molecule drug developed by Shanghai Junshi Bioscience Co., Ltd.. It is currently in Phase 1 development.
Cetuximab Solution for infusion is an epidermal growth factor receptor (EGFR) inhibitor used to treat conditions such as Head and Neck Squamous Cell Carcinoma, BRAF V600E-mutated/MSS Metastatic Colorectal Cancer, and Metastatic Colorectal Cancer. It is administered via infusion and works by inhibiting the epidermal growth factor receptor (EGFR) through its mechanism as an antibody inhibitor.
-
Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Cetuximab Solution for infusion |
|---|---|
| Sponsor | Shanghai Junshi Bioscience Co., Ltd. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC (PHASE3)
- A Phase I Comparative Study of Pharmacokinetics, Safety, and Efficacy of RPH-002 and Erbitux® in Unresectable Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma (PHASE1)
- A Comparative Study of Efficacy and Safety of RPH-002 and Erbitux® in Unresectable Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma (PHASE3)
- A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors (PHASE1, PHASE2)
- Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-1971 in Combination With Either Osimertinib in Participants With Unresectable, Locally Advanced, or Metastatic Non-Small Cell Lung Cancer, or With Cetuximab in Participants With Metastatic Colorectal Cancer (PHASE1)
- A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With Gastrointestinal Cancer (Master Protocol) (Pegathor Gastrointestinal 203) (PHASE2)
- A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With HNSCC (Master Protocol) (Pegathor Head and Neck 204) (PHASE2)
- A Study of HRS-4642 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Cetuximab Solution for infusion CI brief — competitive landscape report
- Cetuximab Solution for infusion updates RSS · CI watch RSS
- Shanghai Junshi Bioscience Co., Ltd. portfolio CI
Frequently asked questions about Cetuximab Solution for infusion
What is Cetuximab Solution for infusion?
Who makes Cetuximab Solution for infusion?
What development phase is Cetuximab Solution for infusion in?
Related
- Manufacturer: Shanghai Junshi Bioscience Co., Ltd. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing