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Human TH-SC01 Cell Injection
Human TH-SC01 Cell Injection is a Biologic drug developed by Jiangsu Topcel-KH Pharmaceutical Co., Ltd.. It is currently in Phase 1 development.
Human TH-SC01 cell injection is a protein-based intervention being studied for the treatment of Crohn's Disease, Complex Perianal Fistulas, Anal Fistula, and Perianal Fistula. It is being investigated in a Phase 3 clinical trial as a potential treatment for perianal fistulas in patients with Crohn's Disease.
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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 | Human TH-SC01 Cell Injection |
|---|---|
| Sponsor | Jiangsu Topcel-KH Pharmaceutical Co., Ltd. |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Phase 3 Study of Human TH-SC01 Cell Injection for Treating Perianal Fistulas in Patients With Crohn's Disease (PHASE3)
- A Study of Human TH-SC01 Cell Injection for Treating Perianal Fistulas in Patients With Crohn's Disease (PHASE1, PHASE2)
- Evaluate the Distribution and Dynamic Behavior of TH-SC01 Cells in Vivo in Patients With Perianal Fistula (PHASE1)
- The Purpose of This Study is to Evaluate the Safety and Efficacy of Human TH-SC01 Cell Injection in the Treatment of Complex Perianal Fistula (PHASE1, PHASE2)
- A Study of TH-SC01 for Treating Complex Perianal Fistula in Perianal Crohn's Disease. (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:
- Human TH-SC01 Cell Injection CI brief — competitive landscape report
- Human TH-SC01 Cell Injection updates RSS · CI watch RSS
- Jiangsu Topcel-KH Pharmaceutical Co., Ltd. portfolio CI
Frequently asked questions about Human TH-SC01 Cell Injection
What is Human TH-SC01 Cell Injection?
Who makes Human TH-SC01 Cell Injection?
What development phase is Human TH-SC01 Cell Injection in?
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing