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SHR-A2102 and Adebrelimab
SHR-A2102 and Adebrelimab is a PD-1 inhibitor Small molecule drug developed by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. It is currently in Phase 3 development for Non-small cell lung cancer, PD-L1 positive, Head and neck squamous cell carcinoma.
SHR-A2102 and Adebrelimab are anti-PD-1 monoclonal antibodies that inhibit the PD-1/PD-L1 interaction.
SHR-A2102 is being studied in combination with other antitumor drugs for the treatment of Advanced Breast Cancer. Adebrelimab is also being studied in various conditions, including Advanced Solid Tumors, Locally Advanced or Metastatic Urothelial Carcinoma, and Advanced or Metastatic 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 | SHR-A2102 and Adebrelimab |
|---|---|
| Sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
| Drug class | PD-1 inhibitor |
| Target | PD-1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
By blocking this interaction, SHR-A2102 and Adebrelimab enhance T-cell activation and proliferation, leading to anti-tumor immune responses. This mechanism is similar to other PD-1 inhibitors, such as pembrolizumab and nivolumab.
Approved indications
- Non-small cell lung cancer, PD-L1 positive
- Head and neck squamous cell carcinoma
Common side effects
- Fatigue
- Diarrhea
- Nausea
- Rash
- Pruritus
Key clinical trials
- A Trial of SHR-A2102 With Adebrelimab in Locally Advanced or Metastatic Urothelial Carcinoma (PHASE3)
- Exploratory Platform Research on Precision Therapy of Advanced Pancreatic Cancer (PHASE2)
- A Trial of SHR-A2102 With Adebrelimab With or Without Other Antitumor Therapy in Advanced or Metastatic Non-small Cell Lung Cancer (PHASE1, PHASE2)
- A Trial of SHR-A2102 With Adebrelimab With or Without Other Anti-tumor Therapies in Recurrent/MetastaticHead and Neck Squamous Cell Carcinoma Cancer (PHASE1, PHASE2)
- Study of SHR-A2102 Combined Other Antitumor Drugs in Advanced Breast Cancer (PHASE2)
- A Trial of SHR-A2102 With Adebrelimab With or Without Other Antitumor Therapy in Advanced or Metastatic Esophageal Cancer (PHASE1, PHASE2)
- A Trial of SHR-A2102 With or Without Antitumor Therapy in Advanced Solid Tumors (PHASE1, PHASE2)
- A Trial of SHR-A2102 With Antitumor Therapy in Advanced Urothelial Carcinoma (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:
- SHR-A2102 and Adebrelimab CI brief — competitive landscape report
- SHR-A2102 and Adebrelimab updates RSS · CI watch RSS
- Suzhou Suncadia Biopharmaceuticals Co., Ltd. portfolio CI
Frequently asked questions about SHR-A2102 and Adebrelimab
What is SHR-A2102 and Adebrelimab?
How does SHR-A2102 and Adebrelimab work?
What is SHR-A2102 and Adebrelimab used for?
Who makes SHR-A2102 and Adebrelimab?
What drug class is SHR-A2102 and Adebrelimab in?
What development phase is SHR-A2102 and Adebrelimab in?
What are the side effects of SHR-A2102 and Adebrelimab?
What does SHR-A2102 and Adebrelimab target?
Related
- Drug class: All PD-1 inhibitor drugs
- Target: All drugs targeting PD-1
- Manufacturer: Suzhou Suncadia Biopharmaceuticals Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Non-small cell lung cancer, PD-L1 positive
- Indication: Drugs for Head and neck squamous cell carcinoma
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing