Last reviewed · How we verify
HRS-4357 injection
HRS-4357 injection is a Anti-angiogenic agent / VEGF inhibitor Small molecule drug developed by Jiangsu HengRui Medicine Co., Ltd.. It is currently in Phase 3 development for Advanced or metastatic solid tumors (specific indications under investigation in Phase 3).
HRS-4357 is an anti-angiogenic agent that inhibits vascular endothelial growth factor (VEGF) signaling to suppress tumor blood vessel formation.
HRS-4357 injection is being studied in a Phase 1/2 clinical trial for the treatment of Advanced Prostate Cancer and PSMA-Positive Progressive Metastatic Castration-Resistant Prostate Cancer. The trial is comparing the safety and efficacy of HRS-4357 injection to Enzalutamide and Abiraterone.
-
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 | HRS-4357 injection |
|---|---|
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. |
| Drug class | Anti-angiogenic agent / VEGF inhibitor |
| Target | VEGF receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
HRS-4357 functions as a VEGF pathway inhibitor, blocking the formation of new blood vessels that tumors depend on for growth and metastasis. By targeting VEGF receptors, the drug starves tumors of their blood supply, thereby inhibiting tumor progression. This anti-angiogenic mechanism is commonly employed in oncology to restrict tumor vascularization and growth.
Approved indications
- Advanced or metastatic solid tumors (specific indications under investigation in Phase 3)
Common side effects
- Hypertension
- Proteinuria
- Fatigue
- Diarrhea
- Hand-foot skin reaction
Key clinical trials
- A Phase III Study Comparing HRS-4357 With Novel Androgen Receptor Pathway Inhibitors in Patients With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (PHASE3)
- Phase 1/2 Clinical Study of HRS-4357 in Patients With Advanced Prostate Cancer (PHASE1, 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:
- HRS-4357 injection CI brief — competitive landscape report
- HRS-4357 injection updates RSS · CI watch RSS
- Jiangsu HengRui Medicine Co., Ltd. portfolio CI
Frequently asked questions about HRS-4357 injection
What is HRS-4357 injection?
How does HRS-4357 injection work?
What is HRS-4357 injection used for?
Who makes HRS-4357 injection?
What drug class is HRS-4357 injection in?
What development phase is HRS-4357 injection in?
What are the side effects of HRS-4357 injection?
What does HRS-4357 injection target?
Related
- Drug class: All Anti-angiogenic agent / VEGF inhibitor drugs
- Target: All drugs targeting VEGF receptor
- Manufacturer: Jiangsu HengRui Medicine Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Advanced or metastatic solid tumors (specific indications under investigation in Phase 3)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing