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pegfilgrastim (QL0605 / QL 0605 / pegfilgrastim, Qilu)

✓ Approved

Qilu Pharmaceutical · CSF3R · Recombinant Proteins

What is pegfilgrastim?

pegfilgrastim is a recombinant proteins developed by Qilu Pharmaceutical. It is approved for therapeutic indications via injectable (others) or subcutaneous injection.

Drug Profile

Brand NamesQL0605, QL 0605, pegfilgrastim, Qilu
CompanyQilu Pharmaceutical
Drug ClassRecombinant Proteins
Molecular TargetCSF3R
RouteInjectable (Others), Subcutaneous Injection
StatusApproved
Sources: ClinicalTrials.gov, Qilu Pharmaceutical

Mechanism of Action

Molecular Targets

pegfilgrastim acts on 1 molecular target:

CSF3Rcolony stimulating factor 3 receptor (CD114, GCSFR)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

pegfilgrastim is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Blood and lymphatic system disordersBone marrow disorder✓ Approved

Related Research Articles

PubMedJCO global oncology2026-08-20

Accelerated Methotrexate, Vinblastine, Doxorubicin, and Cisplatin for Muscle-Invasive Bladder Cancer: Real-World Feasibility and Safety in a Resource-Constrained Setting.

Sundriyal Deepak D, Prasath Sai S, Prakash Harsha S HS, Swamy Anusha Mruthyunjaya AM et al.

Muscle-invasive bladder carcinoma (MIBC) poses major treatment challenges in low- and middle-income countries because of logistical and socioeconomic barriers limiting neoadjuvant chemotherapy (NAC) delivery. While dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) improves pathologic response and survival over gemcitabine-cisplatin, its multiday schedule reduces practicality. Accelerated MVAC (AMVAC), a single-day outpatient regimen, may offer a feasible alternative. This study evaluated the feasibility and safety of AMVAC in Indian patients with MIBC. We conducted a single-arm feasibility study at the All India Institute of Medical Sciences, Rishikesh, India, between December 2021 and November 2024. Adults with stage II-III MIBC and cisplatin eligibility received 3-4 cycles of single-day AMVAC with pegfilgrastim support before radical cystectomy. Feasibility was defined as completion of ≥3 or 4 cycles within protocol-specified timeframes. Toxicities were graded using CTCAE v5.0, and outcomes were analyzed descriptively. Sixty patients were enrolled (mean age 55.2 ± 11.2 years; 90% male); 55 received neoadjuvant, and five adjuvant therapy. The mean number of chemotherapy cycles delivered was 3.87 ± 0.85. Feasibility outcomes were favorable, with 91.6% completing three and 76.6% completing four cycles within protocol timelines. Dose reductions for grade ≥3 toxicities were required in 13 patients (21.7%), whereas four patients discontinued treatment because of reduced creatinine clearance. Grade 3 adverse events occurred in 38.3%, most commonly anemia (16.7%), fatigue, and mucositis (13.3% each). Among neoadjuvant recipients undergoing cystectomy (n = 40), pathologic complete response (PCR) was achieved in 32.5% and pathologic downstaging was achieved in 55%. Single-day AMVAC is a feasible and tolerable NAC regimen in a resource-constrained setting, with encouraging PCR and manageable toxicity.

PMID 42623591
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PubMedBreast cancer (Tokyo, Japan)2026-08-14

Risk of febrile neutropenia in breast cancer chemotherapy despite the prophylactic use of pegfilgrastim: a retrospective analysis.

Kusama Hiroki H, Horimoto Yoshiya Y, Iwai Kyoko K, Kitaoku Yuki Y et al.

Pegfilgrastim, a long-acting granulocyte colony-stimulating factor (G-CSF), is used to prevent febrile neutropenia (FN) in breast cancer patients undergoing chemotherapy. However, a small subset of patients still develops FN. This study aimed to assess the real-world incidence of FN and identify potential risk factors in this specific population. This retrospective study included breast cancer patients who received pegfilgrastim prophylaxis at Tokyo Medical University Hospital between February 2019 and December 2024. Inclusion required pegfilgrastim use at least once during chemotherapy. FN was defined as an absolute neutrophil count below 500/µL (or a predicted ANC below 1,000/µL) and an axillary temperature 37.5 °C or higher. Cases of FN and associated risk factors were analyzed using logistic regression models. This study included 378 patients (median age 53). Tumor subtypes were luminal (50.0%), HER2-positive (20.9%), and triple-negative (29.1%), with dose-dense regimens being the most common (55.8%). Of 2,784 total chemotherapy administrations, pegfilgrastim was used in 2,125 cycles (76.3%). The incidence of FN despite pegfilgrastim was 2.1% (8/378), with the highest rate observed in immune checkpoint inhibitor-containing regimens (9.1%, 2/22). Multivariate analysis identified a low baseline platelet count as a significant independent risk factor for combined FN and grade 3-4 neutropenia (OR: 0.98; 95% CI: 0.96-0.99; P = 0.02). Although pegfilgrastim is effective, FN still occurs in a small percentage of patients. A low baseline platelet count was associated with an increased risk of FN or severe neutropenia despite pegfilgrastim prophylaxis, though this finding requires confirmation in larger studies given the limited number of events.

PMID 42599616
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PubMedJMA journal2026-08-11

Efficacy of Early Pegfilgrastim Administration during Preoperative Docetaxel, Cisplatin, and 5-Fluorouracil Therapy in Esophageal Cancer.

Takei Masahiro M, Tsujimoto Hironori H, Ide Asuma A, Kariya Risa R et al.

Docetaxel, cisplatin, and 5-fluorouracil (DCF) therapy is the standard preoperative chemotherapy for advanced esophageal cancer. Although pegfilgrastim (PEG) is used for prophylaxis, the optimal timing remains unclear. This study aimed to evaluate the safety and efficacy of early PEG administration in DCF therapy. We retrospectively analyzed 50 chemotherapy cycles in 28 patients who underwent preoperative DCF therapy. The patients were divided into two groups based on the timing of PEG administration: day 3 (Early group) and day 7 (Late group). We compared hematologic and nonhematologic toxicities between the groups. Early PEG administration significantly reduced leukopenia (Early group vs. Late group: 14% vs. 64%) and neutropenia (21% vs. 79%) and was associated with a lower incidence of febrile neutropenia (7% vs. 36%). Early PEG administration also reduced the incidence of grade ≥3 diarrhea and anorexia and improved food oral intake, weight loss, hyponatremia, and anorexia. Early administration of PEG on day 3 during preoperative DCF therapy for esophageal cancer significantly reduced severe neutropenia and was associated with improved treatment tolerability compared to standard day 7 administration. These findings suggest that early PEG administration is a safe and effective strategy to enhance the tolerability of intensive chemotherapy.

PMID 42576986
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PubMedIJU case reports2026-08-06

Carboplatin Monotherapy Induced Complete Response in Elderly Metastatic Seminoma and CKD: A Case Report.

Omae Gento G, Kitamura Kosuke K, Muto Satoru S

Cisplatin-based chemotherapy is the standard treatment for metastatic seminoma but may be unsuitable for elderly patients with comorbidities. We report a case of metastatic seminoma with chronic kidney disease (CKD) in an elderly patient successfully treated with carboplatin monotherapy. A 70-year-old man presented with a left testicular tumor and para-aortic lymphadenopathy, causing left-sided hydronephrosis. Radical left high orchiectomy confirmed stage IIC pure seminoma pT1N3M0 with a favorable prognosis according to the International Germ Cell Cancer Collaborative Group classification. Because renal impairment and poor performance status precluded cisplatin-based chemotherapy, the patient received four cycles of carboplatin monotherapy (AUC 7). Grade 2-3 pancytopenia occurred but was manageable with pegfilgrastim and dose interval adjustment. Post-treatment PET-CT showed no residual uptake. Consolidation para-aortic radiotherapy was subsequently performed. The patient remains disease-free 1.5 years after treatment. Carboplatin monotherapy may be a feasible alternative for metastatic seminoma patients who are unsuitable for cisplatin-based chemotherapy.

PMID 42559124
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PubMedEClinicalMedicine2026-08-02

Comparative efficacy and safety of four long-acting granulocyte colony-stimulating factors for primary prophylaxis in patients with breast cancer: a prospective observational cohort study in China.

Guo Zihan Z, Hu Jinwei J, Mo Miao M, Wang Mengmeng M et al.

Long-acting granulocyte colony-stimulating factors (G-CSFs) are the standard of care for primary prophylaxis against chemotherapy-induced neutropenia in breast cancer, but comparative data remain limited. This prospective observational cohort study was conducted at a single center in Shanghai, China. Patients with breast cancer scheduled for high-febrile-neutropenia-risk chemotherapy and planned for long-acting G-CSF primary prophylaxis were eligible. Patients received subcutaneous pegfilgrastim, mecapegfilgrastim, telpegfilgrastim, or efbemalenograstim alfa once per cycle per clinical practice. The primary outcome was the incidence of grade 3/4 neutropenia (leukopenia), assessed during chemotherapy cycles and at follow-up visits. Safety was assessed via bone pain-related treatment-emergent adverse events (BPR TEAEs). Between March 25 and September 30, 2025, 407 patients were analyzed. Grade 3/4 neutropenia (leukopenia) occurred in 24.1%, varying numerically across agents (telpegfilgrastim 30.2%, mecapegfilgrastim 16.4%; overall P = 0.061). After multivariable adjustment, telpegfilgrastim was associated with a higher risk of grade 3/4 neutropenia (leukopenia) versus mecapegfilgrastim (OR = 2.46, P = 0.011). BPR TEAEs occurred in 62.4%, with similar incidence across groups (P = 0.32). Lower BPR TEAE risk was associated with ddEC chemotherapy (OR = 0.32, P = 0.0010) and postmenopausal status (OR = 0.53, P = 0.031). In exploratory analyses, administration at 24-48 h (versus <24 h) was associated with lower grade 4 neutropenia (leukopenia) (9.9% versus 27.3%, P = 0.011) and severe BPR TEAEs (0.5% versus 4.5%, P = 0.032), and a 3 mg pegfilgrastim dose was associated with comparable myeloprotection to 6 mg (29.4% versus 26.5%, P = 0.81) but fewer BPR TEAEs (29.4% versus 60.3%, P = 0.022). All four long-acting G-CSFs demonstrated clinical efficacy. Numerical variations and adjusted analyses indicated distinct clinical profiles, supporting tailored prophylaxis. Optimizing administration timing and considering dose reduction could improve benefit-risk balance. Larger prospective studies are needed to confirm these exploratory findings. None.

PMID 42541270
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PubMedHematology, transfusion and cell therapy2026-07-31

Improving engraftment in autologous hematopoietic stem cell transplantation: comparing pegfilgrastim with filgrastim in an outpatient setting.

Gutierrez-Aguirre Cesar Homero CH, la Garza-Salazar Fernando De F, Gómez-Almaguer David D, Jaime-Pérez José Carlos JC et al.

Febrile neutropenia, a frequent complication in patients undergoing autologous stem cell transplantation, increases morbidity and hospitalization costs. The aim of this study was to compare the efficacy of two formulations of pegylated filgrastim with filgrastim in patients who received autologous stem cell transplantation as outpatients for lymphoma or myeloma. Thirty patients were randomized to receive a single 6 mg dose of either reference or biosimilar pegfilgrastim on Day +1. A retrospective Control Group of fifty-three patients who received filgrastim was included. The median times to neutrophil engraftment were 10, 9 and 11 days for the innovator pegfilgrastim, biosimilar pegfilgrastim (p-value = 0.14), and filgrastim (p-value = 0.0001), respectively. The median times to platelet engraftment were 10 days for both of the pegfilgrastim groups and 12 days for the filgrastim group (p-value = 0.0001). Febrile neutropenia incidence was lower in the pegfilgrastim group (6.7%) than in the filgrastim group (24.5%; p-value = 0.04). Cost analysis showed higher costs for the innovator pegfilgrastim, with filgrastim having the lowest cost of the three formulations. The innovator and the biosimilar pegfilgrastim demonstrated similar efficacy in engraftment speed and febrile neutropenia incidence. Pegfilgrastim was associated with faster engraftment, a lower incidence of platelet transfusion, and a lower incidence of febrile neutropenia.

PMID 42531780
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