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SHR-A1811 for Injection
SHR-A1811 for Injection is a Bispecific monoclonal antibody; dual checkpoint inhibitor Small molecule drug developed by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. It is currently in Phase 3 development for Advanced or metastatic solid tumors (Phase 3 development). Also known as: SHR-A1811 group.
SHR-A1811 is a bispecific antibody that simultaneously engages two immune checkpoints to enhance anti-tumor T-cell responses.
SHR-A1811 for Injection is being studied in a Phase II clinical trial for the treatment of gynaecological malignancies. The exact mechanism of SHR-A1811 is unknown.
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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-A1811 for Injection |
|---|---|
| Also known as | SHR-A1811 group |
| Sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
| Drug class | Bispecific monoclonal antibody; dual checkpoint inhibitor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
SHR-A1811 functions as a bispecific monoclonal antibody designed to target dual immune pathways, likely involving PD-1/PD-L1 and CTLA-4 or similar checkpoint axes. By blocking inhibitory signals on T cells through multiple mechanisms simultaneously, the drug aims to overcome tumor immune evasion and generate more potent anti-tumor immunity than single-checkpoint inhibitors alone.
Approved indications
- Advanced or metastatic solid tumors (Phase 3 development)
Common side effects
- Immune-related adverse events (irAEs)
- Fatigue
- Diarrhea
- Rash
Key clinical trials
- A Trial of SHR-A1811 Compared to Other Antitumor Therapies as Neoadjuvant Treatments in Early-stage or Locally Advanced HER2-positive Breast Cancer (PHASE3)
- A Clinical Study of SHR-A1811(sc) Subcutaneous Injection in Patients With Solid Tumor (PHASE1)
- A Trial of Adebrelimab Plus (SHR-A1811/SHR-A1904 With Chemotherapy) or SHR-8068 as Treatment for Gastric/GEJ Cancer (PHASE2)
- Chemotherapy With or Without Adebrelimab and T-DXh as Neoadjuvant Therapy for HR+/HER2 Low Early Stage Breast Cancer (PHASE2)
- A Clinical Trial of SHR-A1811 in the Treatment of Triple-negative Breast Cancer (PHASE3)
- A Phase II Trial of SHR-A1811 in HER2-Expressing Recurrent/Metastatic Cervical Cancer (PHASE2)
- A Clinical Study of SHR-A1811 Combined With Chemotherapy for Platinum Sensitive Recurrent Ovarian Cancer (PHASE1, PHASE2)
- Maintenance Therapy in HER2-Positive Unresectable Locally Recurrent or Metastatic Breast Cancer: A Phase II Study (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-A1811 for Injection CI brief — competitive landscape report
- SHR-A1811 for Injection updates RSS · CI watch RSS
- Suzhou Suncadia Biopharmaceuticals Co., Ltd. portfolio CI
Frequently asked questions about SHR-A1811 for Injection
What is SHR-A1811 for Injection?
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What is SHR-A1811 for Injection used for?
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Is SHR-A1811 for Injection also known as anything else?
What drug class is SHR-A1811 for Injection in?
What development phase is SHR-A1811 for Injection in?
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Related
- Drug class: All Bispecific monoclonal antibody; dual checkpoint inhibitor drugs
- Manufacturer: Suzhou Suncadia Biopharmaceuticals Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Advanced or metastatic solid tumors (Phase 3 development)
- Also known as: SHR-A1811 group
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing