Last reviewed · How we verify
zorifertinib
zorifertinib is a Small molecule drug developed by Alpha Biopharma (Jiangsu) Co., Ltd.. It is currently in Phase 2 development.
Zorifertinib is a small molecule inhibitor of the epidermal growth factor receptor (EGFR) used to treat non-small-cell lung cancer (NSCLC) with central nervous system (CNS) metastases. It has been approved in China for locally advanced or metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations and CNS metastases.
-
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 | zorifertinib |
|---|---|
| Sponsor | Alpha Biopharma (Jiangsu) Co., Ltd. |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Prospective Cohort Study of Zorifertinib as a First-line Treatment in Patients With Epidermal Growth Factor Receptor-mutant Advanced Non-small Cell Lung Cancer With Central Nervous System (CNS) Metastases
- Zorifertinib With Osimertinib for NSCLC With Meningeal Progression (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:
- zorifertinib CI brief — competitive landscape report
- zorifertinib updates RSS · CI watch RSS
- Alpha Biopharma (Jiangsu) Co., Ltd. portfolio CI
Frequently asked questions about zorifertinib
What is zorifertinib?
Who makes zorifertinib?
What development phase is zorifertinib in?
Related
- Manufacturer: Alpha Biopharma (Jiangsu) Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing