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Cardonilizumab
Cardonilizumab is a Small molecule drug developed by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. It is currently in Phase 2 development. Also known as: PD1 and CTLA-4 bispecific antibody.
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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).
| 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 | Cardonilizumab |
|---|---|
| Also known as | PD1 and CTLA-4 bispecific antibody |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Candonilimab in Combination With LM-302 for Claudin 18.2 Positive-advanced Biliary Tract Cancer After Failure of Standard of Chemotherapy and PD1/PD-L1 Antibody (PHASE1, PHASE2)
- Induction Chemoimmunotherapy Combined With Chemoradiotherapy in Esophageal Cancer (PHASE2)
- Clinical Observation on the Safety and Efficacy of Cardonilmab in the Treatment of Second-line and Above Advanced Melanoma and Advanced Renal Cancer (PHASE2)
- Cardenilimab Combined With Lenvatinib in Patients With Perioperative Resectable Clear Cell Renal Cell Carcinoma. (PHASE2)
- Cadonilimab Combined With Fruquintinib and SBRT as Athird-line and Posterior Line Treatment in Patients With MSS CRC (NA)
- Combination of Cardonizumab Injection and TKI Second Line Therapy for Advanced Hepatocellular Cancer (PHASE1)
- Cryoablation Combined With Cardonilizumab and Bevacizumab in Hepatocellular Carcinoma With Pulmonary Metastases (NA)
- Efficacy and Safety of SBRT Combined With Cardonilizumab and Lenvastinib in the Treatment of Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus (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:
- Cardonilizumab CI brief — competitive landscape report
- Cardonilizumab updates RSS · CI watch RSS
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences portfolio CI
Frequently asked questions about Cardonilizumab
What is Cardonilizumab?
Who makes Cardonilizumab?
Is Cardonilizumab also known as anything else?
What development phase is Cardonilizumab in?
Related
- Manufacturer: Cancer Institute and Hospital, Chinese Academy of Medical Sciences — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: PD1 and CTLA-4 bispecific antibody
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing