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GH21，D-1553
GH21，D-1553 is a Small molecule drug developed by Suzhou Genhouse Bio Co., Ltd.. It is currently in Phase 2 development.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | GH21，D-1553 |
|---|---|
| Sponsor | Suzhou Genhouse Bio Co., Ltd. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Phase 2 Clinical Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GH21 Capsules Combined With D-1553 Tablets in Subjects With Locally Advanced or Metastatic Solid Tumors With the KRASG12C Mutation (PHASE2)
- GH21 Combined With D-1553 in KRAS G12C Mutant Advanced Solid Tumors (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:
- GH21，D-1553 CI brief — competitive landscape report
- GH21，D-1553 updates RSS · CI watch RSS
- Suzhou Genhouse Bio Co., Ltd. portfolio CI
Frequently asked questions about GH21，D-1553
What is GH21，D-1553?
Who makes GH21，D-1553?
What development phase is GH21，D-1553 in?
Related
- Manufacturer: Suzhou Genhouse Bio Co., Ltd. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing