Last reviewed 2026-05-22 · How we verify

YPEG-rhG-CSF

Xiamen Amoytop Biotech Co., Ltd. · Phase 3 active Small molecule ✓ Verified May 2026

YPEG-rhG-CSF is a G-CSF agonist Small molecule drug developed by Xiamen Amoytop Biotech Co., Ltd.. It is currently in Phase 3 development for Prevention of infection in patients undergoing chemotherapy or bone marrow transplantation.

PEG-rhG-CSF is a recombinant human granulocyte colony-stimulating factor (G-CSF) conjugated with polyethylene glycol (PEG), which helps stimulate the production of white blood cells.

YPEG-rhG-CSF is a protein-based intervention used to treat various conditions, including chemotherapy patients, non-myeloid malignancy, non-small cell lung cancer, breast cancer, and solid tumors. It is a modified form of recombinant human granulocyte colony-stimulating factor (rhG-CSF) conjugated with polyethylene glycol (PEG).

Likelihood of approval

61.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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.

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	YPEG-rhG-CSF
Sponsor	Xiamen Amoytop Biotech Co., Ltd.
Drug class	G-CSF agonist
Target	G-CSF receptor
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

This conjugation increases the half-life of G-CSF, allowing for longer-lasting stimulation of white blood cell production. PEG-rhG-CSF is used to prevent infection in patients undergoing chemotherapy or bone marrow transplantation.

Approved indications

Prevention of infection in patients undergoing chemotherapy or bone marrow transplantation

Common side effects

Bone pain
Headache
Fatigue
Nausea
Diarrhea

Key clinical trials

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:

YPEG-rhG-CSF CI brief — competitive landscape report
YPEG-rhG-CSF updates RSS · CI watch RSS
Xiamen Amoytop Biotech Co., Ltd. portfolio CI

Frequently asked questions about YPEG-rhG-CSF

What is YPEG-rhG-CSF?

YPEG-rhG-CSF is a G-CSF agonist drug developed by Xiamen Amoytop Biotech Co., Ltd., indicated for Prevention of infection in patients undergoing chemotherapy or bone marrow transplantation.

How does YPEG-rhG-CSF work?

PEG-rhG-CSF is a recombinant human granulocyte colony-stimulating factor (G-CSF) conjugated with polyethylene glycol (PEG), which helps stimulate the production of white blood cells.

What is YPEG-rhG-CSF used for?

YPEG-rhG-CSF is indicated for Prevention of infection in patients undergoing chemotherapy or bone marrow transplantation.

Who makes YPEG-rhG-CSF?

YPEG-rhG-CSF is developed by Xiamen Amoytop Biotech Co., Ltd. (see full Xiamen Amoytop Biotech Co., Ltd. pipeline at /company/xiamen-amoytop-biotech-co-ltd).

What drug class is YPEG-rhG-CSF in?

YPEG-rhG-CSF belongs to the G-CSF agonist class. See all G-CSF agonist drugs at /class/g-csf-agonist.

What development phase is YPEG-rhG-CSF in?

YPEG-rhG-CSF is in Phase 3.

What are the side effects of YPEG-rhG-CSF?

Common side effects of YPEG-rhG-CSF include Bone pain, Headache, Fatigue, Nausea, Diarrhea.

What does YPEG-rhG-CSF target?

YPEG-rhG-CSF targets G-CSF receptor and is a G-CSF agonist.

Drug class: All G-CSF agonist 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 Prevention of infection in patients undergoing chemotherapy or bone marrow transplantation

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing