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Candonilimab
Candonilimab is a Small molecule drug developed by Shi Ming. It is currently in Phase 2 development.
Candonilimab is being studied in clinical trials for the treatment of Esophageal Squamous Cell Carcinoma, Hepatocellular Carcinoma, Soft Tissue Sarcoma, and Colorectal Cancer (CRC). Candonilimab has been used in combination with other treatments, including fruquintinib, bevacizumab, and a combination of tegafur, gimeracil, and oteracil potassium, in clinical trials.
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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 | Candonilimab |
|---|---|
| Sponsor | Shi Ming |
| 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)
- Efficacy and Safety of Cadonilimab Plus Anlotinib in Advanced STS That Failed the Previous First-line Standard Treatment (PHASE2)
- Candonilimab and ATRA Acid for Prevention of Oral Cancer Recurrence in Patients With OPL (PHASE2)
- The Efficacy and Safety of LM-302 in Combination With Candonilimab and Capecitabine for First-Line Treatment in Patients With Unresectable Advanced, Recurrent, or Metastatic CLDN18.2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma (PHASE2)
- Cadonilimab Combined With Regorafenib as A Third-line Treatment in Patients With MSS CRLM (PHASE2)
- A Phase lb/lI Clinical Study in Advanced or Metastatic Esophageal Squamous Cell Carcinoma (PHASE2)
- Cadonilimab With Chemotherapy in Treating Advanced Biliary Cancer (PHASE2)
- Candonilimab (AK104) Plus Preoperative Chemotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma (ESCC) (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:
- Candonilimab CI brief — competitive landscape report
- Candonilimab updates RSS · CI watch RSS
- Shi Ming portfolio CI
Frequently asked questions about Candonilimab
What is Candonilimab?
Who makes Candonilimab?
What development phase is Candonilimab in?
Related
- Manufacturer: Shi Ming — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing