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FDA018-ADC
FDA018-ADC is a Antibody-drug conjugate (ADC) Small molecule drug developed by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.. It is currently in Phase 3 development for Solid tumors (specific indication under investigation in Phase 3). Also known as: FDA018-Antibody-drug Conjugate, F0024.
FDA018-ADC is an antibody-drug conjugate that delivers cytotoxic payload to target cells expressing specific tumor antigens.
FDA018-ADC is an antibody-drug conjugate that delivers cytotoxic payload to target cells expressing specific tumor antigens. Used for Solid tumors (specific indication under investigation in Phase 3).
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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). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| 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 | FDA018-ADC |
|---|---|
| Also known as | FDA018-Antibody-drug Conjugate, F0024 |
| Sponsor | Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. |
| Drug class | Antibody-drug conjugate (ADC) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
As an ADC (antibody-drug conjugate), FDA018-ADC combines a monoclonal antibody with a potent cytotoxic drug linker. The antibody component binds to a tumor-associated antigen on cancer cells, enabling selective delivery of the toxic payload to malignant cells while sparing healthy tissue. This targeted approach aims to improve efficacy and reduce systemic toxicity compared to conventional chemotherapy.
Approved indications
- Solid tumors (specific indication under investigation in Phase 3)
Common side effects
- Peripheral neuropathy
- Cytopenias
- Nausea/vomiting
- Fatigue
Key clinical trials
- A Study of FDA018-ADC in Patients With Advanced Solid Tumors (PHASE1)
- FDA018-ADC vs Investigator's Choice Chemotherapy to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer (PHASE3)
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:
- FDA018-ADC CI brief — competitive landscape report
- FDA018-ADC updates RSS · CI watch RSS
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. portfolio CI
Frequently asked questions about FDA018-ADC
What is FDA018-ADC?
How does FDA018-ADC work?
What is FDA018-ADC used for?
Who makes FDA018-ADC?
Is FDA018-ADC also known as anything else?
What drug class is FDA018-ADC in?
What development phase is FDA018-ADC in?
What are the side effects of FDA018-ADC?
Related
- Drug class: All Antibody-drug conjugate (ADC) drugs
- Manufacturer: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Solid tumors (specific indication under investigation in Phase 3)
- Also known as: FDA018-Antibody-drug Conjugate, F0024
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing