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Adebrelimab injection
Adebrelimab injection is a PD-L1 inhibitor Small molecule drug developed by Shanghai Hengrui Pharmaceutical Co., Ltd.. It is currently in Phase 3 development for Non-small cell lung cancer, Other solid tumors (under investigation in Phase 3). Also known as: Ai Rui Li, SHR-1316.
Adebrelimab is a monoclonal antibody that blocks the PD-L1 checkpoint, enhancing anti-tumor immune responses by preventing PD-L1 from binding to PD-1 and B7.1 receptors on immune cells.
Adebrelimab is a monoclonal antibody that blocks the PD-L1 checkpoint, enhancing anti-tumor immune responses by preventing PD-L1 from binding to PD-1 and B7.1 receptors on immune cells. Used for Non-small cell lung cancer, Other solid tumors (under investigation in Phase 3).
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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 | Adebrelimab injection |
|---|---|
| Also known as | Ai Rui Li, SHR-1316 |
| Sponsor | Shanghai Hengrui Pharmaceutical Co., Ltd. |
| Drug class | PD-L1 inhibitor |
| Target | PD-L1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
By inhibiting the PD-L1/PD-1 axis, adebrelimab removes the inhibitory signal that tumors use to evade immune surveillance, allowing T cells and other immune effectors to recognize and attack cancer cells more effectively. This mechanism is similar to other PD-L1 inhibitors and represents a form of immune checkpoint inhibition used in cancer immunotherapy.
Approved indications
- Non-small cell lung cancer
- Other solid tumors (under investigation in Phase 3)
Common side effects
- Fatigue
- Decreased appetite
- Immune-related adverse events (pneumonitis, hepatitis, colitis)
- Infusion-related reactions
Key clinical trials
- A Phase II Study of SHR-8068 Injection in Combination With Anti-tumor Therapies in Colorectal Cancer (PHASE2)
- A Phase III Study of HS-20093 Injection Combined With Adebrelimab Versus Docetaxel in Previously Treated Patients With Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations (PHASE3)
- A Trial of SHR-A2102 With Adebrelimab in Locally Advanced or Metastatic Urothelial Carcinoma (PHASE3)
- Adebrelimab Combined With Chemotherapy for the Esophageal Squamous Cell Carcinoma (NA)
- A Phase III Study of SHR-A1811 in Combination With Chemotherapy and Adebrelimab in Previously Untreated Patients With Gastric or Gastroesophageal Junction Adenocarcinoma (PHASE3)
- A Phase III Study of SHR-8068 in Combination With Adebrelimab and Platinum-Containing Chemotherapy Versus Durvalumab in Combination With Platinum-Containing Chemotherapy as First-line Treatment for Advanced Biliary Tract Cancer (BTC) (PHASE3)
- Exploration of Treatment Strategies After Concurrent Chemoradiotherapy for LS-SCLC Guided by MRD (PHASE2)
- HRS-4642 Combination With Other Antitumor Therapies in Patients With Solid Tumors (PHASE1, 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:
- Adebrelimab injection CI brief — competitive landscape report
- Adebrelimab injection updates RSS · CI watch RSS
- Shanghai Hengrui Pharmaceutical Co., Ltd. portfolio CI
Frequently asked questions about Adebrelimab injection
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Related
- Drug class: All PD-L1 inhibitor drugs
- Target: All drugs targeting PD-L1
- Manufacturer: Shanghai Hengrui Pharmaceutical Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Non-small cell lung cancer
- Indication: Drugs for Other solid tumors (under investigation in Phase 3)
- Also known as: Ai Rui Li, SHR-1316
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing