Last reviewed · How we verify
Almonertinib
Almonertinib is a Small molecule drug developed by First People's Hospital of Hangzhou. It is currently in Phase 3 development. Also known as: Thoracic Radiotherapy, ctDNA dynamic monitoring guided the Almonertinib treatment, Anlotinib, HS-10296.
-
Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Almonertinib |
|---|---|
| Also known as | Thoracic Radiotherapy, ctDNA dynamic monitoring guided the Almonertinib treatment, Anlotinib, HS-10296, Lastet |
| Sponsor | First People's Hospital of Hangzhou |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Double-Dose Third-Generation EGFR-TKI Plus Bevacizumab and Intrathecal Chemotherapy for Refractory Leptomeningeal Metastatic NSCLC: A Phase II Study (NA)
- A Study of SHR-A2009 Combined With Aumolertinib Versus Aumolertinib for First-line Treatment in EGFR-mutated, Advanced or Metastatic NSCLC (PHASE3)
- A Study of Aumolertinib in European Participants With Non-Small Cell Lung Cancer (PHASE1)
- A Study of HS-20117 Combined With Aumolertinib in Participants With Advanced Non-Squamous Non-Small Cell Lung Cancer (PHASE2, PHASE3)
- A Study of BL-B01D1 and Almonertinib in Patients With Resectable EGFR+ Stage II-IIIB NSCLC (PHASE2)
- A Study of Almonertinib Combined With Palbociclib in Patients With Advanced Solid Tumors Harboring KRAS Mutations (PHASE1, PHASE2)
- Third-generation EGFR-TKI Treatment in Metastatic EGFR-mutant NSCLC
- A Study Evaluating the Effect of Aumolertinib on the Pharmacokinetics of Midazolam in Patients With NSCLC (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:
- Almonertinib CI brief — competitive landscape report
- Almonertinib updates RSS · CI watch RSS
- First People's Hospital of Hangzhou portfolio CI
Frequently asked questions about Almonertinib
What is Almonertinib?
Who makes Almonertinib?
Is Almonertinib also known as anything else?
What development phase is Almonertinib in?
Related
- Manufacturer: First People's Hospital of Hangzhou — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Thoracic Radiotherapy, ctDNA dynamic monitoring guided the Almonertinib treatment, Anlotinib, HS-10296, Lastet
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing