Mecapegfilgrastim
Also known as: AGEN-1, Jinhao, mecapegfilgrastim, PEG-rhG-CSF, Pegfilgrastim biosimilar, 津优力
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Summary
Mecapegfilgrastim is a pegylated recombinant human granulocyte‑colony stimulating factor (G‑CSF) biosimilar approved in China for prophylaxis of chemotherapy‑induced neutropenia and febrile neutropenia in patients with solid tumours and non‑myeloid haematologic malignancies. It is administered as a single subcutaneous injection per chemotherapy cycle to reduce the depth and duration of neutropenia and the associated infection risk.
Mechanism of Action
Mecapegfilgrastim mimics endogenous G‑CSF and binds the G‑CSF receptor on myeloid progenitor cells in the bone marrow. This activates the JAK/STAT signaling cascade, promoting proliferation, differentiation, and functional activation of neutrophil precursors. Pegylation prolongs systemic exposure, allowing a sustained rise in circulating neutrophils after a single dose, thereby supporting host defence during the nadir phase after cytotoxic chemotherapy.
What the Research Shows
Clinical evidence includes a single‑arm pediatric pilot (30 RMS/ES patients) showing a 6.7% febrile neutropenia (FN) rate and 26.7% grade 4 neutropenia after one cycle of mecapegfilgrastim 100 µg/kg. A phase III NSCLC trial demonstrated that a single 100 µg/kg or fixed 6 mg dose reduced grade ≥ 3 neutropenia and FN to a degree comparable with daily short‑acting G‑CSF. A phase II nasopharyngeal carcinoma study reported only 6.7% grade ≥ 3 neutropenia and no FN. A multicentre DLBCL pilot (28 vs 14 controls) found a reduction in grade ≥ 3 neutropenia (32% vs 64%) and no FN in the mecapegfilgrastim arm. A 2019 network meta‑analysis of 73 RCTs ranked mecapegfilgrastim among the most effective G‑CSFs for lowering FN, severe neutropenia, and bone pain. Safety across studies was generally comparable to filgrastim, with mostly mild‑moderate adverse events.
Reported Benefits
Across tumour types, mecapegfilgrastim consistently lowered the incidence of grade ≥ 3 neutropenia and FN, often matching or surpassing daily filgrastim in efficacy. Its long half‑life permits a single subcutaneous injection per chemotherapy cycle, simplifying dosing and improving patient convenience. Reported tolerability is comparable to other G‑CSFs, with most adverse events being mild to moderate and no unexpected safety signals identified.
Limitations of the Evidence
Most data derive from small, single‑arm or pilot studies, limiting statistical power and generalisability. Randomised evidence is limited to a few phase III trials (NSCLC) and a modest DLBCL pilot; pediatric data lack a control group. Studies are predominantly conducted in Chinese populations, so extrapolation to other ethnic groups remains uncertain. Long‑term outcomes and head‑to‑head comparisons with other long‑acting G‑CSFs are scarce.
Safety Considerations
Mecapegfilgrastim is generally well tolerated; most treatment‑emergent adverse events are mild or moderate, mirroring the safety profile of filgrastim. Bone pain, a common G‑CSF side effect, was reported but not at higher rates than comparators. No serious unexpected adverse events were observed in the cited trials. Antibiotic use was frequent in the pediatric cohort (70%), reflecting infection risk despite prophylaxis. Serious adverse events were rare and comparable between mecapegfilgrastim and control arms.
How It Is Administered
The drug is given subcutaneously, typically 24–48 hours after chemotherapy completion. Dosing options include a weight‑adjusted 100 µg/kg dose (maximum 6 mg) or a fixed 6 mg dose, administered once per chemotherapy cycle. No dose adjustments for renal or hepatic impairment are described in the abstracts.
Routes of Administration
Goals & Uses
- Mobilization of peripheral blood progenitor cellsStem Cell TransplantationLow
- Support for stem cell mobilizationHematologyModerate
- Chemotherapy‑induced neutropenia prophylaxisOncologyHigh
- Reduction of duration of severe neutropeniaHematologic SupportHigh
- Prevention of chemotherapy-induced febrile neutropeniaHematologic Support / Oncology Supportive CareHigh
Contraindications
- Hypersensitivity to G‑CSF or PEGAllergyHigh
- Myeloid malignancies (AML, CML, MDS)OncologicHigh
- Use within 14 days before or 24 hours after cytotoxic chemotherapyTiming RestrictionHigh
- Hypersensitivity to filgrastim, pegfilgrastim, or E. coli-derived proteinsAllergy / ImmunologicHigh
- Sickle cell diseaseHematologyModerate
Adverse Effects
- Acute respiratory distress syndrome (ARDS)PulmonaryRare
- Splenomegaly / splenic ruptureOrgan ToxicityRare
- Bone painMusculoskeletalCommon
- Injection site reactionsLocalCommon
- LeukocytosisHematologicUncommon
- Hypersensitivity reactionImmunologicUncommon
- Splenic ruptureGastrointestinal/HematologicRare
- Allergic/hypersensitivity reactionsImmunologicalUncommon
- Bone pain / musculoskeletal painMusculoskeletalCommon
Drug Interactions
- Cytotoxic chemotherapy agentsHigh
- Concurrent myeloid growth factorsModerate
- Cytotoxic chemotherapyLow
- LithiumLow
Population Constraints
- PregnancyReproductive SafetyRelative
- Pediatric patientsAgeRelative
- LactationReproductiveRelative
- Sickle cell diseaseHematologicRelative
- Pregnant womenReproductiveRelative
- Pediatric patients <2 yearsAgeAbsolute
Regulatory Status
- European UnionApprovedApproved: prevention of chemotherapy‑induced neutropeniaEMA‑approved biosimilar of pegfilgrastim
- United StatesInvestigationalNot yet FDA‑approved as of 2026
- United KingdomUnapprovedNot approved by MHRA as of knowledge cutoff; approved and marketed in China by CSPC Pharmaceutical
Approved by China's National Medical Products Administration (NMPA) for reduction of chemotherapy-induced neutropenia. Not approved by US FDA or EMA as of knowledge cutoff.
Evidence & Sources
- Journal ArticleModerateZhao W, et al.2024-01-01T00:00:00.000000Z
- Journal ArticleHighWang Y, et al.2019-01-01T00:00:00.000000Z
- Journal ArticleModerateZhou C, et al.2016-01-01T00:00:00.000000Z
- Journal ArticleModerateJin Q, et al.2025-01-01T00:00:00.000000Z
- Journal ArticleModerateAl-Salama ZT, Keam SJ2019-01-01T00:00:00.000000Z
- Journal ArticleModerateWang J, et al.2026-01-01T00:00:00.000000Z
Frequently Asked Questions
What type of cancer patients can receive mecapegfilgrastim?
It is approved for patients with non‑myeloid malignancies receiving myelosuppressive chemotherapy that carries a clinically significant risk of febrile neutropenia, including lung, breast, head‑and‑neck, nasopharyngeal, sarcoma, and diffuse large B‑cell lymphoma.
How does mecapegfilgrastim compare to daily filgrastim?
Randomised data in advanced non‑small‑cell lung cancer showed comparable reductions in grade ≥ 3 neutropenia and febrile neutropenia. Meta‑analysis also ranked it among the most effective G‑CSFs, with a similar safety profile.
Is mecapegfilgrastim safe for children?
A prospective pilot in 30 pediatric and adolescent sarcoma patients reported low febrile neutropenia rates and acceptable safety, though the study lacked a control group, so evidence remains limited.
What are the common side effects?
The most frequently reported adverse events are mild‑to‑moderate bone pain and injection‑site reactions. Serious adverse events are rare and comparable to those seen with other G‑CSFs.
What is Mecapegfilgrastim?
Mecapegfilgrastim is a pegylated recombinant human granulocyte‑colony stimulating factor (G‑CSF) biosimilar approved in China for prophylaxis of chemotherapy‑induced neutropenia and febrile neutropenia in patients with solid tumours and non‑myeloid haematologic malignancies. It is administered as a single subcutaneous injection per chemotherapy cycle to reduce the depth and duration of neutropenia and the associated infection risk.
What is Mecapegfilgrastim used for?
Mecapegfilgrastim is educationally associated with: Mobilization of peripheral blood progenitor cells, Support for stem cell mobilization, Chemotherapy‑induced neutropenia prophylaxis, Reduction of duration of severe neutropenia, Prevention of chemotherapy-induced febrile neutropenia. Educational only — not medical advice.
How is Mecapegfilgrastim administered?
Recorded routes of administration: Subcutaneous.
What are the potential side effects of Mecapegfilgrastim?
Reported adverse effects include: Acute respiratory distress syndrome (ARDS), Splenomegaly / splenic rupture, Bone pain, Injection site reactions, Leukocytosis, Hypersensitivity reaction, Splenic rupture, Allergic/hypersensitivity reactions, Bone pain / musculoskeletal pain. This list is not exhaustive — consult a qualified clinician.
Who should avoid Mecapegfilgrastim?
Recorded contraindications: Hypersensitivity to G‑CSF or PEG, Myeloid malignancies (AML, CML, MDS), Use within 14 days before or 24 hours after cytotoxic chemotherapy, Hypersensitivity to filgrastim, pegfilgrastim, or E. coli-derived proteins, Sickle cell disease. Consult a qualified clinician before use.