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T3011 middle dose
T3011 middle dose is a Biologic drug developed by Shanghai Pharmaceuticals Holding Co., Ltd. It is currently in Phase 1 development.
T3011 is a small molecule being studied in a clinical trial for the treatment of advanced solid tumors. The trial is evaluating the tolerability of T3011 in combination with PD-1/PD-L1 inhibitors at different doses, including high dose, middle dose, and low dose.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | T3011 middle dose |
|---|---|
| Sponsor | Shanghai Pharmaceuticals Holding Co., Ltd |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Clinical Study of T3011 in Combination With PD-1/PD-L1 Inhibitors in Subjects With Advanced 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:
- T3011 middle dose CI brief — competitive landscape report
- T3011 middle dose updates RSS · CI watch RSS
- Shanghai Pharmaceuticals Holding Co., Ltd portfolio CI
Frequently asked questions about T3011 middle dose
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Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing