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Sindilimab
Sindilimab is a Small molecule drug developed by Zhejiang Cancer Hospital. It is currently in Phase 1 development.
Sindilimab is a programmed cell death 1 receptor antagonist/inhibitor being studied in clinical trials for various conditions, including cervical cancer, chemotherapy effect, and non-small cell lung cancer stage IV. It is typically used in combination with other treatments, such as paclitaxel and cisplatin, for neoadjuvant chemotherapy in locally advanced cervical cancer.
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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 | Sindilimab |
|---|---|
| Sponsor | Zhejiang Cancer Hospital |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- The Safety and Efficacy of Transarterial Chemoembolization (TACE) + Lenvatinib + Programmed Cell Death Protein 1 (PD-1) Antibody of Advanced Unresectable Hepatocellular Carcinoma (PHASE1, PHASE2)
- Nimotuzumab Combined With Sintilimab and Chemotherapy for Advanced Esophageal Squamous Cell Carcinoma (PHASE2)
- Efficacy and Toxicity of Paclitaxel, Cisplatin Combined With Sindilimab in NACT for Locally Advanced Cervical Cancer (PHASE2)
- The Efficacy and Safety of Lenvatinib Combined With Sindilimab and Nab-paclitaxel in the First-line Treatment for Recurrent and Metastatic Triple Negative Breast Cancer: a Phase Ib/IIa Clinical Trial. (PHASE1, PHASE2)
- TACE Combined With Sintilimab Plus Bevacizumab Biosimilar in Hepatocellular Carcinoma (BCLC-C Stage ): a Prospective Single-arm Phase II Clinical Study (PHASE2)
- SRS Sequential Sindilimab in Brain Metastasis of NSLSC (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:
- Sindilimab CI brief — competitive landscape report
- Sindilimab updates RSS · CI watch RSS
- Zhejiang Cancer Hospital portfolio CI
Frequently asked questions about Sindilimab
What is Sindilimab?
Who makes Sindilimab?
What development phase is Sindilimab in?
Related
- Manufacturer: Zhejiang Cancer Hospital — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing