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IBI310&Sintilimab
IBI310&Sintilimab is a Bispecific antibody (IBI310) + PD-1 inhibitor (Sintilimab) Small molecule drug developed by Innovent Biologics (Suzhou) Co. Ltd.. It is currently in Phase 3 development for Advanced or metastatic solid tumors (Phase 3 development), Non-small cell lung cancer.
IBI310 is a bispecific antibody that simultaneously blocks CTLA-4 and TIM-3 checkpoints to enhance anti-tumor immunity, while Sintilimab is a PD-1 inhibitor that releases PD-1-mediated immune suppression.
IBI310 is a bispecific antibody that simultaneously blocks CTLA-4 and TIM-3 checkpoints to enhance anti-tumor immunity, while Sintilimab is a PD-1 inhibitor that releases PD-1-mediated immune suppression. Used for Advanced or metastatic solid tumors (Phase 3 development), Non-small cell lung cancer.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | IBI310&Sintilimab |
|---|---|
| Sponsor | Innovent Biologics (Suzhou) Co. Ltd. |
| Drug class | Bispecific antibody (IBI310) + PD-1 inhibitor (Sintilimab) |
| Target | CTLA-4, TIM-3 (IBI310); PD-1 (Sintilimab) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
This combination targets multiple immune checkpoints to overcome tumor-induced T-cell exhaustion through complementary mechanisms. IBI310 engages both CTLA-4 and TIM-3 on T cells to promote activation and proliferation, while Sintilimab blocks the PD-1/PD-L1 axis. The dual checkpoint blockade is designed to produce synergistic anti-tumor effects by addressing different pathways of immune evasion.
Approved indications
- Advanced or metastatic solid tumors (Phase 3 development)
- Non-small cell lung cancer
Common side effects
- Immune-related adverse events (irAEs)
- Fatigue
- Diarrhea
- Rash
- Elevated liver enzymes
Key clinical trials
- A Study to Evaluate the Efficacy and Safety of IBI310 and Sintilimab Combination Therapy in Patients With Hepatocellular Carcinoma as First-line Treatment. (PHASE2, PHASE3)
- A Study to Compare the Effectiveness and Safety of IBI310 Combined With Sintilimab Versus Sorafenib in the First-line Treatment of Advanced HCC (PHASE3)
- A Prospective, Randomized Study of TACE Combined With Sintilimab, Bevacizumab, and Ipilimumab N01 Treating Advanced HCC (PHASE2)
- Efficacy of Anti-CTLA-4 Antibody Combined With Sintilimab and Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-III Non-Small Cell Lung Cancer (PHASE2)
- Sintilimab Combined With IBI310 and Surufatinib for the Treatment of G3-NET and NEC (NESSIE) (PHASE2)
- IBI310 in Combination with Sintilimab in Patients with DNA Mismatch Repair Deficient (dMMR)/microsatellite Instability High (MSI-H) Locally-advanced or Metastatic Colorectal Cancer (PHASE2)
- Efficacy of PD-1 Inhibitor Combination Therapy in Non-small Cell Lung Cancer Patients Who Have Not Achieved Major Pathologic Response After Neoadjuvant Immunotherapy: a Multicenter, Phase II Clinical Trial (PHASE2)
- Efficacy and Safety of IBI310 Combined with Sintilimab in Patients with Advanced Hepatocellular Carcinoma (PHASE1)
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:
- IBI310&Sintilimab CI brief — competitive landscape report
- IBI310&Sintilimab updates RSS · CI watch RSS
- Innovent Biologics (Suzhou) Co. Ltd. portfolio CI
Frequently asked questions about IBI310&Sintilimab
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Related
- Drug class: All Bispecific antibody (IBI310) + PD-1 inhibitor (Sintilimab) drugs
- Target: All drugs targeting CTLA-4, TIM-3 (IBI310); PD-1 (Sintilimab)
- Manufacturer: Innovent Biologics (Suzhou) Co. Ltd. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Advanced or metastatic solid tumors (Phase 3 development)
- Indication: Drugs for Non-small cell lung cancer
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing