Last reviewed · How we verify
Sindillimab
Sindillimab is a Small molecule drug developed by Xin-Hua Xu. It is currently in Phase 2 development. Also known as: Pembrolizumab, Nivolumab, Durvalumab.
Sindillimab is being studied in clinical trials for the treatment of Non-small Cell Lung Cancer, Third-line Treatment, Advanced Duodenal Adenocarcinoma, and in combination with furquimatinib and sintilimab. The exact mechanism of action of Sindillimab is not specified in the provided information, but it is being studied in combination with other treatments, including sintilimab, which is a PD-1 inhibitor.
-
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 | Sindillimab |
|---|---|
| Also known as | Pembrolizumab, Nivolumab, Durvalumab |
| Sponsor | Xin-Hua Xu |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Clinical Study on Third-line Treatment of Advanced Duodenal Adenocarcinoma by Fuquinitinib Combined With Sindillimab
- Foundation and Clinical About the Expression of PD-1 in Peripheral Blood T Lymphocytes (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:
- Sindillimab CI brief — competitive landscape report
- Sindillimab updates RSS · CI watch RSS
- Xin-Hua Xu portfolio CI
Frequently asked questions about Sindillimab
What is Sindillimab?
Who makes Sindillimab?
Is Sindillimab also known as anything else?
What development phase is Sindillimab in?
Related
- Manufacturer: Xin-Hua Xu — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Pembrolizumab, Nivolumab, Durvalumab
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing