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IBI305
IBI305 is a PD-L1 inhibitor Small molecule drug developed by Innovent Biologics (Suzhou) Co. Ltd.. It is currently in Phase 3 development for Non-small cell lung cancer, Gastric cancer, Esophageal cancer. Also known as: Bevacizumab Biosimilar, Bevacizumab, anti-VEGF monoclonal antibody.
IBI305 is a PD-L1 inhibitor that blocks the interaction between PD-L1 on tumor cells and PD-1/B7.1 on immune cells, thereby restoring anti-tumor immune responses.
IBI305 is a PD-L1 inhibitor that blocks the interaction between PD-L1 on tumor cells and PD-1/B7.1 on immune cells, thereby restoring anti-tumor immune responses. Used for Non-small cell lung cancer, Gastric cancer, Esophageal 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 | IBI305 |
|---|---|
| Also known as | Bevacizumab Biosimilar, Bevacizumab, anti-VEGF monoclonal antibody |
| Sponsor | Innovent Biologics (Suzhou) Co. Ltd. |
| Drug class | PD-L1 inhibitor |
| Target | PD-L1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
IBI305 is a fully human monoclonal antibody that targets programmed death ligand 1 (PD-L1). By binding to PD-L1, it prevents the engagement of PD-1 and B7.1 receptors on T cells, reversing tumor-mediated immune suppression and allowing cytotoxic T lymphocytes to recognize and eliminate cancer cells. This mechanism is similar to other checkpoint inhibitors in the PD-L1/PD-1 pathway.
Approved indications
- Non-small cell lung cancer
- Gastric cancer
- Esophageal cancer
Common side effects
- Fatigue
- Decreased appetite
- Nausea
- Immune-related adverse events (pneumonitis, hepatitis, colitis)
Key clinical trials
- Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer (PHASE3)
- Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (PHASE2, PHASE3)
- Osimertinib With or Without Bevacizumab as Initial Treatment for Patients With EGFR-Mutant Lung Cancer (PHASE3)
- Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer (PHASE3)
- A Study to Determine Whether Chemotherapy and Atezolizumab is Better Than Chemotherapy, Bevacizumab and Atezolizumab in Patients With Advanced Liver Cancer (PHASE2)
- Testing the Addition of Atezolizumab to Combination Chemotherapy or Atezolizumab Alone for Metastatic Colon or Rectal Cancer, the COMMIT Study (PHASE3)
- Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer (PHASE1)
- Testing of Bevacizumab, Erlotinib, and Atezolizumab in Combination for Advanced-Stage Kidney Cancer (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:
- IBI305 CI brief — competitive landscape report
- IBI305 updates RSS · CI watch RSS
- Innovent Biologics (Suzhou) Co. Ltd. portfolio CI
Frequently asked questions about IBI305
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Related
- Drug class: All PD-L1 inhibitor drugs
- Target: All drugs targeting PD-L1
- Manufacturer: Innovent Biologics (Suzhou) Co. Ltd. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Non-small cell lung cancer
- Indication: Drugs for Gastric cancer
- Indication: Drugs for Esophageal cancer
- Also known as: Bevacizumab Biosimilar, Bevacizumab, anti-VEGF monoclonal antibody
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing