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Fluzoparib Capsules
Fluzoparib Capsules is a PARP inhibitor Small molecule drug developed by The First Affiliated Hospital of Xiamen University. It is currently in Phase 3 development for BRCA-mutated ovarian cancer, BRCA-mutated breast cancer, Homologous recombination deficient ovarian cancer. Also known as: SHR-3162, Poly (ADP-ribose) polymerase (PARP) inhibitor.
Fluzoparib is a PARP inhibitor that blocks poly(ADP-ribose) polymerase enzymes, preventing DNA repair in cancer cells and leading to cell death.
Fluzoparib is a small molecule used in clinical trials for various cancer types, including recurrent and metastatic gastric cancer, triple negative breast cancer, and ovarian cancer. It is being studied in combination with apatinib and paclitaxel in a phase I clinical trial.
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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 | Fluzoparib Capsules |
|---|---|
| Also known as | SHR-3162, Poly (ADP-ribose) polymerase (PARP) inhibitor |
| Sponsor | The First Affiliated Hospital of Xiamen University |
| Drug class | PARP inhibitor |
| Target | PARP1/PARP2 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
PARP inhibitors like fluzoparib trap PARP proteins on DNA and prevent the repair of single-strand breaks, which accumulate into lethal double-strand breaks in cancer cells. This mechanism is particularly effective in tumors with BRCA1/2 mutations or homologous recombination deficiency, where alternative DNA repair pathways are already compromised. The drug forces cancer cells into apoptosis while having relatively less impact on normal cells with intact DNA repair mechanisms.
Approved indications
- BRCA-mutated ovarian cancer
- BRCA-mutated breast cancer
- Homologous recombination deficient ovarian cancer
Common side effects
- Anemia
- Nausea
- Fatigue
- Thrombocytopenia
- Leukopenia
Key clinical trials
- A Single-Arm Phase Ⅱ Study of Fluzoparib Maintenance in Platinum-sensitive Advanced Triple-Negative Breast Cance (PHASE2)
- Randomized, Open, Controlled, Multicenter Phase III Clinical Study of Fluzoparib in Combination With Apatinib Versus Investigator-Selected Chemotherapy for HRD-Positive/HER2-negative Advanced Breast Cancer (PHASE3)
- A Clinical Study of JS105 in Combination With Other Anti-tumor Therapies in Patients With Solid Tumors (PHASE1, PHASE2)
- A Trial of Maintenance Treatment With Fluzoparib Versus Placebo in Relapsed Ovarian Cancer Patients (PHASE3)
- Fluzoparib+Bevacizumab/Dietary Intervention vs Fluzoparib Monotherapy as First-line Maintenance in HRD+/- Advanced Ovarian Cancer (PHASE3)
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study of Fuzuloparib Combined With Abiraterone Acetate and Prednisone (AA-P) Versus Placebo Combined With AA-P as First-Line Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer (PHASE3)
- Fluzoparib With or Without Bevacizumab for Neoadjuvant Therapy in Advanced Ovarian Cancer (PHASE2)
- Fluzoparib Neoadjuvant Therapy for Ovarian Cancer (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:
- Fluzoparib Capsules CI brief — competitive landscape report
- Fluzoparib Capsules updates RSS · CI watch RSS
- The First Affiliated Hospital of Xiamen University portfolio CI
Frequently asked questions about Fluzoparib Capsules
What is Fluzoparib Capsules?
How does Fluzoparib Capsules work?
What is Fluzoparib Capsules used for?
Who makes Fluzoparib Capsules?
Is Fluzoparib Capsules also known as anything else?
What drug class is Fluzoparib Capsules in?
What development phase is Fluzoparib Capsules in?
What are the side effects of Fluzoparib Capsules?
What does Fluzoparib Capsules target?
Related
- Drug class: All PARP inhibitor drugs
- Target: All drugs targeting PARP1/PARP2
- Manufacturer: The First Affiliated Hospital of Xiamen University — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for BRCA-mutated ovarian cancer
- Indication: Drugs for BRCA-mutated breast cancer
- Indication: Drugs for Homologous recombination deficient ovarian cancer
- Also known as: SHR-3162, Poly (ADP-ribose) polymerase (PARP) inhibitor
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing