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SSS11
SSS11 is a Biologic drug developed by Shenyang Sunshine Pharmaceutical Co., LTD.. It is currently in Phase 1 development. Also known as: pegsiticase.
SSS11 is a Pegylated Recombinant Candida Utilis Uricase for Injection being studied for its safety, tolerability, and pharmacokinetics in healthy adult volunteers. It is also being investigated for its potential to treat Gout and Hyperuricemia.
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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 | SSS11 |
|---|---|
| Also known as | pegsiticase |
| Sponsor | Shenyang Sunshine Pharmaceutical Co., LTD. |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Safety, Tolerability, and Pharmacokinetic Characteristics of SSS11 in Patients With Gout and Hyperuricemia (PHASE1)
- A Study to Determine the Safety, Tolerability, PK and Preliminary PD of SSS11 in Chinese Healthy Adult Volunteers (PHASE1)
- A Study to Assess the Safety and Tolerability of SSS11 in Healthy Subjects. (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:
- SSS11 CI brief — competitive landscape report
- SSS11 updates RSS · CI watch RSS
- Shenyang Sunshine Pharmaceutical Co., LTD. portfolio CI
Frequently asked questions about SSS11
What is SSS11?
Who makes SSS11?
Is SSS11 also known as anything else?
What development phase is SSS11 in?
Related
- Manufacturer: Shenyang Sunshine Pharmaceutical Co., LTD. — full pipeline
- Also known as: pegsiticase
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing