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GenSci098
GenSci098 is a Small molecule drug developed by Changchun GeneScience Pharmaceutical Co., Ltd.. It is currently in Phase 1 development.
GenSci098 is a medication being studied in a Phase I clinical trial to evaluate its safety and tolerability in subjects with Graves' Disease. The trial also involves studying GenSci098 in subjects with Thyroid Eye Disease (TED) and assessing its pharmacokinetics and pharmacodynamics.
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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 | GenSci098 |
|---|---|
| Sponsor | Changchun GeneScience Pharmaceutical Co., Ltd. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Study of GensSci098 in Subjects With Graves' Disease (PHASE1)
- A Study of GenSci098 in Subjects With Active Thyroid Eye 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:
- GenSci098 CI brief — competitive landscape report
- GenSci098 updates RSS · CI watch RSS
- Changchun GeneScience Pharmaceutical Co., Ltd. portfolio CI
Frequently asked questions about GenSci098
What is GenSci098?
Who makes GenSci098?
What development phase is GenSci098 in?
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing