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CMAB009 plus Irinotecan
CMAB009 plus Irinotecan is a PD-1 inhibitor and topoisomerase I inhibitor Small molecule drug developed by Shanghai Zhangjiang Biotechnology Limited Company. It is currently in Phase 2 development for Metastatic colorectal cancer. Also known as: YiMaiLin for irinotecan.
CMAB009 is a PD-1 inhibitor, and Irinotecan is a topoisomerase I inhibitor.
CMAB009 is a small molecule inhibitor of DNA topoisomerase 1. It is being studied in combination with Irinotecan, a DNA topoisomerase 1 inhibitor, for the treatment of metastatic colorectal cancer, specifically in patients with KRAS wild-type tumors.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | CMAB009 plus Irinotecan |
|---|---|
| Also known as | YiMaiLin for irinotecan |
| Sponsor | Shanghai Zhangjiang Biotechnology Limited Company |
| Drug class | PD-1 inhibitor and topoisomerase I inhibitor |
| Target | PD-1 and topoisomerase I |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
CMAB009 works by binding to PD-1 and blocking its interaction with PD-L1, thereby enhancing T-cell activation and anti-tumor response. Irinotecan works by inhibiting topoisomerase I, an enzyme involved in DNA replication, leading to DNA damage and apoptosis in rapidly dividing cancer cells.
Approved indications
- Metastatic colorectal cancer
Common side effects
- Diarrhea
- Fatigue
- Nausea
- Vomiting
- Neutropenia
- Leukopenia
- Anemia
- Thrombocytopenia
Key clinical trials
- Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial (PHASE3)
- Utomilumab, Cetuximab, and Irinotecan Hydrochloride in Treating Patients With Metastatic Colorectal Cancer (PHASE1)
- Vemurafenib, Cetuximab, and Irinotecan Hydrochloride in Treating Patients With Solid Tumors That Are Metastatic or That Cannot Be Removed by Surgery (PHASE1)
- CMAB009 Combined With FOLFIRI First-line Treatment in Patients With RAS/BRAF Wild-type, Metastatic Colorectal Cancer (PHASE3)
- Regorafenib, With Cetuximab or Panitumumab, for the Treatment of Unresectable, Locally Advanced, or Metastatic Colorectal Cancer (PHASE2)
- Irinotecan and Cetuximab With or Without Bevacizumab in Treating Patients With RAS Wild-Type Locally Advanced or Metastatic Colorectal Cancer That Cannot Be Removed by Surgery (PHASE2)
- Study of CMAB009 to Treat KRAS Wild Type Metastatic Colorectal Cancer (PHASE2, PHASE3)
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:
- CMAB009 plus Irinotecan CI brief — competitive landscape report
- CMAB009 plus Irinotecan updates RSS · CI watch RSS
- Shanghai Zhangjiang Biotechnology Limited Company portfolio CI
Frequently asked questions about CMAB009 plus Irinotecan
What is CMAB009 plus Irinotecan?
How does CMAB009 plus Irinotecan work?
What is CMAB009 plus Irinotecan used for?
Who makes CMAB009 plus Irinotecan?
Is CMAB009 plus Irinotecan also known as anything else?
What drug class is CMAB009 plus Irinotecan in?
What development phase is CMAB009 plus Irinotecan in?
What are the side effects of CMAB009 plus Irinotecan?
What does CMAB009 plus Irinotecan target?
Related
- Drug class: All PD-1 inhibitor and topoisomerase I inhibitor drugs
- Target: All drugs targeting PD-1 and topoisomerase I
- Manufacturer: Shanghai Zhangjiang Biotechnology Limited Company — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic colorectal cancer
- Also known as: YiMaiLin for irinotecan
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing