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Rh-endostatin
Rh-endostatin is a Angiogenesis inhibitor Small molecule drug developed by Guangzhou Institute of Respiratory Disease. It is currently in Phase 3 development for Non-small cell lung cancer, Other solid tumors (in development). Also known as: Pembrolizumab, carboplatin, cisplatin, pemetrexed.
Rh-endostatin inhibits angiogenesis by blocking new blood vessel formation, thereby starving tumors of their blood supply.
Rh-endostatin is used in combination with thoracic irradiation of 50 Gy and possibly other treatments for the conditions studied, including Lung Cancer, Non Small Cell Lung Cancer, Colorectal Neoplasms, and Non-small Cell Lung Cancer. The exact mechanism of Rh-endostatin is not specified in the provided facts, but it is listed as recombinant human endostatin (Endostar) in ClinicalTrials.gov.
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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 | Rh-endostatin |
|---|---|
| Also known as | Pembrolizumab, carboplatin, cisplatin, pemetrexed, [nab]-paclitaxel |
| Sponsor | Guangzhou Institute of Respiratory Disease |
| Drug class | Angiogenesis inhibitor |
| Target | VEGF signaling pathway; endothelial cells |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Endostatin is an endogenous angiogenesis inhibitor derived from collagen XVIII. Rh-endostatin (recombinant human endostatin) works by suppressing vascular endothelial growth factor (VEGF) signaling and inhibiting endothelial cell proliferation and migration, preventing the formation of new blood vessels that tumors require for growth and metastasis.
Approved indications
- Non-small cell lung cancer
- Other solid tumors (in development)
Common side effects
- Hypertension
- Proteinuria
- Fatigue
- Hemorrhage
Key clinical trials
- Intra-arterial Cisplatin Plus Rh-endostatin Combined With Systematic Chemotherapy in Osteosarcoma (PHASE1, PHASE2)
- Efficacy and Safety of Sintilimab Combined with Nab-PP Plus Rh-endostatin in Locally Advanced/advanced and Recurrent Metastatic Squamous Non-small Cell Lung Cancer: a Single-arm, Multicenter Clinical Study (PHASE2)
- Modified CV Regimen in Optic Pathway Glioma (PHASE2)
- Study of Recombinant Human Endostatin Combined With CV Regimen in the Treatment of Pediatric Low-grade Gliomas (PHASE2)
- Rh-Endostatin Combined With CCRT(50 Gy) Followed by Durvalumab Maintenance for the Treatment of Specific Phase III NSCLC (PHASE4)
- Rh-endostatin Combined With Chemotherapy and Pembrolizumab for Advanced NSCLC (PHASE2)
- Rh-Endostatin (Endostar®) Continuous Intravenous Infusion (PHASE2)
- Recombinant Human Endostatin(Rh-endostatin) Combine With Radiotherapy in the Treatment of Hepatocellular Carcinoma(HCC) (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:
- Rh-endostatin CI brief — competitive landscape report
- Rh-endostatin updates RSS · CI watch RSS
- Guangzhou Institute of Respiratory Disease portfolio CI
Frequently asked questions about Rh-endostatin
What is Rh-endostatin?
How does Rh-endostatin work?
What is Rh-endostatin used for?
Who makes Rh-endostatin?
Is Rh-endostatin also known as anything else?
What drug class is Rh-endostatin in?
What development phase is Rh-endostatin in?
What are the side effects of Rh-endostatin?
What does Rh-endostatin target?
Related
- Drug class: All Angiogenesis inhibitor drugs
- Target: All drugs targeting VEGF signaling pathway; endothelial cells
- Manufacturer: Guangzhou Institute of Respiratory Disease — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Non-small cell lung cancer
- Indication: Drugs for Other solid tumors (in development)
- Also known as: Pembrolizumab, carboplatin, cisplatin, pemetrexed, [nab]-paclitaxel
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing