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SHR-A2009 monotherapy
SHR-A2009 monotherapy is a Bispecific monoclonal antibody 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).
SHR-A2009 is a bispecific antibody that simultaneously engages two immune checkpoints to enhance anti-tumor T-cell responses.
SHR-A2009 is a bispecific antibody that simultaneously engages two immune checkpoints to enhance anti-tumor T-cell responses. Used for Advanced or metastatic solid tumors (Phase 3 development).
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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-A2009 monotherapy |
|---|---|
| Sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
| Drug class | Bispecific monoclonal antibody |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
SHR-A2009 is designed as a bispecific monoclonal antibody targeting immune checkpoint pathways to overcome tumor immune evasion. By engaging multiple immune regulatory pathways simultaneously, it aims to enhance T-cell activation and proliferation against cancer cells. This dual-targeting approach may provide superior efficacy compared to single-checkpoint inhibitors.
Approved indications
- Advanced or metastatic solid tumors (Phase 3 development)
Common side effects
- Immune-related adverse events
- Infusion reactions
- Fatigue
Key clinical trials
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-A2009 monotherapy CI brief — competitive landscape report
- SHR-A2009 monotherapy updates RSS · CI watch RSS
- Suzhou Suncadia Biopharmaceuticals Co., Ltd. portfolio CI
Frequently asked questions about SHR-A2009 monotherapy
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Related
- Drug class: All Bispecific monoclonal antibody 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)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing