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Dositinib mesylate tablets
Dositinib mesylate tablets is a Small molecule drug developed by Henan Genuine Biotech Co., Ltd.. It is currently in Phase 1 development. Also known as: 90-1408.
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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 | Dositinib mesylate tablets |
|---|---|
| Also known as | 90-1408 |
| Sponsor | Henan Genuine Biotech Co., Ltd. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Phase Ⅰ/Ⅱa Clinical Study of GEN-725 in Combination With Dositinib (PHASE1, PHASE2)
- A Dose-escalation and Dose-expansion Phase I/Phase II Clinical Study of Dositinib Mesylate Tablets (90-1408) in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer With Positive EGFR Mutation (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:
- Dositinib mesylate tablets CI brief — competitive landscape report
- Dositinib mesylate tablets updates RSS · CI watch RSS
- Henan Genuine Biotech Co., Ltd. portfolio CI
Frequently asked questions about Dositinib mesylate tablets
What is Dositinib mesylate tablets?
Who makes Dositinib mesylate tablets?
Is Dositinib mesylate tablets also known as anything else?
What development phase is Dositinib mesylate tablets in?
Related
- Manufacturer: Henan Genuine Biotech Co., Ltd. — full pipeline
- Also known as: 90-1408
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing