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rhG-CSF/PEG-rhG-CSF
rhG-CSF/PEG-rhG-CSF is a Growth factor Small molecule drug developed by Xiamen Amoytop Biotech Co., Ltd.. It is currently in Phase 3 development for Neutropenia in patients undergoing chemotherapy.
rhG-CSF/PEG-rhG-CSF stimulates the production of white blood cells.
rhG-CSF/PEG-rhG-CSF is a protein-based treatment used to stimulate the production of white blood cells, particularly granulocytes, in patients undergoing intensive chemotherapy for breast cancer. It has been studied in clinical trials for various conditions, including graft-versus-host disease and gynecologic malignant tumors, in addition to its use in breast cancer treatment.
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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 | rhG-CSF/PEG-rhG-CSF |
|---|---|
| Sponsor | Xiamen Amoytop Biotech Co., Ltd. |
| Drug class | Growth factor |
| Target | G-CSF receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
This is achieved by mimicking the action of granulocyte colony-stimulating factor (G-CSF), a naturally occurring protein that promotes the growth and differentiation of neutrophils, a type of white blood cell. The addition of polyethylene glycol (PEG) to rhG-CSF increases its half-life, allowing for more sustained and effective stimulation of white blood cell production.
Approved indications
- Neutropenia in patients undergoing chemotherapy
Common side effects
- Bone pain
- Headache
- Fatigue
- Nausea
- Diarrhea
Key clinical trials
- A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplant (PHASE1)
- Phase 1/2 Trial to Evaluate the Safety and Efficacy of PEEL-224 in Combination With Vincristine and Temozolomide in Adolescents and Young Adults With Relapsed or Refractory Sarcomas (PHASE1, PHASE2)
- Evaluating Premedication Regimens (Methylprednisolone vs Dexamethasone-based) for the Prevention of Systemic and Injection Site Reactions to Motixafortide in Patients With Multiple Myeloma Undergoing Stem Cell Mobilization, PARADE Trial (PHASE4)
- Combination Chemotherapy (FLAG-Ida) Followed Immediately by Reduced-Intensity Total Body Radiation Therapy and Donor Hematopoietic Cell Transplant for the Treatment of Adults Age 60 and Older With Newly Diagnosed Adverse-Risk Acute Myeloid Leukemia or Other High-Grade Myeloid Cancer (PHASE2)
- Reduced Intensity Haploidentical Transplantation for the Treatment of Primary or Secondary Myelofibrosis (PHASE2)
- Comparison Study of EAP and Disease-Specific Chemotherapy Regimens in Hematopoietic Stem Cell Mobilization for Lymphoma (PHASE3)
- Yttrium-90 Labeled Anti-CD25 Monoclonal Antibody Combined With BEAM Chemotherapy Conditioning for the Treatment of Primary Refractory or Relapsed Hodgkin Lymphoma (PHASE2)
- 211At-BC8-B10 Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory High-Risk Acute Leukemia or Myelodysplastic Syndrome (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:
- rhG-CSF/PEG-rhG-CSF CI brief — competitive landscape report
- rhG-CSF/PEG-rhG-CSF updates RSS · CI watch RSS
- Xiamen Amoytop Biotech Co., Ltd. portfolio CI
Frequently asked questions about rhG-CSF/PEG-rhG-CSF
What is rhG-CSF/PEG-rhG-CSF?
How does rhG-CSF/PEG-rhG-CSF work?
What is rhG-CSF/PEG-rhG-CSF used for?
Who makes rhG-CSF/PEG-rhG-CSF?
What drug class is rhG-CSF/PEG-rhG-CSF in?
What development phase is rhG-CSF/PEG-rhG-CSF in?
What are the side effects of rhG-CSF/PEG-rhG-CSF?
What does rhG-CSF/PEG-rhG-CSF target?
Related
- Drug class: All Growth factor drugs
- Target: All drugs targeting G-CSF receptor
- Manufacturer: Xiamen Amoytop Biotech Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Neutropenia in patients undergoing chemotherapy
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing