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Fluzoparib; Apatinib
Fluzoparib; Apatinib is a PARP inhibitor + tyrosine kinase inhibitor (combination therapy) Small molecule drug developed by Jiangsu HengRui Medicine Co., Ltd.. It is currently in Phase 3 development for Ovarian cancer (BRCA-mutated or homologous recombination-deficient), Gastric cancer, Other solid tumors in phase 3 evaluation.
Fluzoparib is a PARP inhibitor that blocks DNA repair, while apatinib is a tyrosine kinase inhibitor targeting VEGFR2, together enhancing anti-tumor effects through synthetic lethality and anti-angiogenesis.
Fluzoparib is a PARP inhibitor that blocks DNA repair, while apatinib is a tyrosine kinase inhibitor targeting VEGFR2, together enhancing anti-tumor effects through synthetic lethality and anti-angiogenesis. Used for Ovarian cancer (BRCA-mutated or homologous recombination-deficient), Gastric cancer, Other solid tumors in phase 3 evaluation.
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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; Apatinib |
|---|---|
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. |
| Drug class | PARP inhibitor + tyrosine kinase inhibitor (combination therapy) |
| Target | PARP1/PARP2; VEGFR2 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Fluzoparib inhibits poly(ADP-ribose) polymerase (PARP), preventing DNA repair in homologous recombination-deficient tumors and inducing synthetic lethality. Apatinib selectively inhibits vascular endothelial growth factor receptor 2 (VEGFR2), blocking tumor angiogenesis. The combination leverages both DNA damage accumulation and vascular disruption to enhance anti-tumor activity.
Approved indications
- Ovarian cancer (BRCA-mutated or homologous recombination-deficient)
- Gastric cancer
- Other solid tumors in phase 3 evaluation
Common side effects
- Anemia
- Thrombocytopenia
- Nausea/vomiting
- Fatigue
- Hypertension
- Hand-foot skin reaction
Key clinical trials
- Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing (PHASE2)
- Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (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)
- Neoadjuvant SNF Precision Therapy Phase III (PHASE3)
- A Study of Apatinib Combined With Letrozole With or Without Fluzoparib in Estrogen Receptor-Positive, Platinum-Sensitive Recurrent Ovarian Cancer Previously Treated With First-Line PARP Inhibitor (NA)
- A Phase 2 Trial of Fluzoparib Combined With Apatinib Versus Fluzoparib Monotherapy in Treatment With Relapsed Ovarian Cancer Patients (PHASE2)
- A Trial of SHR3162 Combined With Apatinib Mesylate Tablets or SHR3162 Monotherapy in Patients With Metastatic Castration Resistant Prostate Cancer (PHASE2)
- SNF Platform Study of HR+/ HER2-advanced Breast 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; Apatinib CI brief — competitive landscape report
- Fluzoparib; Apatinib updates RSS · CI watch RSS
- Jiangsu HengRui Medicine Co., Ltd. portfolio CI
Frequently asked questions about Fluzoparib; Apatinib
What is Fluzoparib; Apatinib?
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Who makes Fluzoparib; Apatinib?
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What does Fluzoparib; Apatinib target?
Related
- Drug class: All PARP inhibitor + tyrosine kinase inhibitor (combination therapy) drugs
- Target: All drugs targeting PARP1/PARP2; VEGFR2
- Manufacturer: Jiangsu HengRui Medicine Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Ovarian cancer (BRCA-mutated or homologous recombination-deficient)
- Indication: Drugs for Gastric cancer
- Indication: Drugs for Other solid tumors in phase 3 evaluation
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing