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SHR-2002 and SHR-1316
SHR-2002 and SHR-1316 is a Small molecule drug developed by Atridia Pty Ltd.. It is currently in Phase 1 development.
SHR-2002 and SHR-1316 are being studied in a Phase I clinical trial for the treatment of advanced malignant tumors. The exact mechanism of SHR-2002 and SHR-1316 is unknown, but they are related to IL-15 SUPER-AGONIST SHR1501.
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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 | SHR-2002 and SHR-1316 |
|---|---|
| Sponsor | Atridia Pty Ltd. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Phase I Study of SHR-2002 + SHR-1316 in Patients With Advanced Malignant Tumors (PHASE1)
- A Trial of SHR-2002 Injection or Combined With Other Anti-cancer Medication in Advanced Malignant Tumors of Patients (PHASE1)
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-2002 and SHR-1316 CI brief — competitive landscape report
- SHR-2002 and SHR-1316 updates RSS · CI watch RSS
- Atridia Pty Ltd. portfolio CI
Frequently asked questions about SHR-2002 and SHR-1316
What is SHR-2002 and SHR-1316?
Who makes SHR-2002 and SHR-1316?
What development phase is SHR-2002 and SHR-1316 in?
Related
- Manufacturer: Atridia Pty Ltd. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing