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AN0025
AN0025 is a Small molecule drug developed by Adlai Nortye Biopharma Co., Ltd.. It is currently in Phase 1 development. Also known as: E7046, Paclitaxel, Carboplatin, Radiotherapy.
AN0025 is being studied in combination with chemoradiotherapy in patients with locally advanced or locally recurrent esophageal cancer. AN0025 is also being investigated in clinical trials for other cancer types, including triple-negative breast cancer, non-small cell lung cancer, and urothelial carcinoma of the bladder.
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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 | AN0025 |
|---|---|
| Also known as | E7046, Paclitaxel, Carboplatin, Radiotherapy, Platinum-based chemotherapy |
| Sponsor | Adlai Nortye Biopharma Co., Ltd. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Double/Triple Combinations of AN2025, AN0025 and Atezolizumab in Advanced Solid Tumors (PHASE1)
- A Trial of AN0025 With Chemoradiation Therapy in Stage III NSCLC Participants (PHASE1)
- AN0025 and Chemoradiotherapy Combination in Esophageal Cancer (PHASE1)
- AN0025 and Pembrolizumab Combination in Advanced Solid Tumors (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:
- AN0025 CI brief — competitive landscape report
- AN0025 updates RSS · CI watch RSS
- Adlai Nortye Biopharma Co., Ltd. portfolio CI
Frequently asked questions about AN0025
What is AN0025?
Who makes AN0025?
Is AN0025 also known as anything else?
What development phase is AN0025 in?
Related
- Manufacturer: Adlai Nortye Biopharma Co., Ltd. — full pipeline
- Also known as: E7046, Paclitaxel, Carboplatin, Radiotherapy, Platinum-based chemotherapy
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing