Pegneugen (telpegfilgrastim) / Xiamen Amoytop Biotech - LARVOL DELTA

A Multicenter, Randomized, Controlled Study of Telpegfilgrastim Versus Filgrastim for Secondary Prevention of Chemotherapy-Induced Neutropenia in Children and Adolescents With Solid Tumors Receiving High-Intensity Chemotherapy Regimens (ESMO 2026) - No abstract available

Clinical • Chemotherapy-Induced Neutropenia • Oncology • Solid Tumor

Efficacy and Safety of Telpegfilgrastim for Preventing Chemotherapy-Induced Neutropenia in Patients with Hematological Malignancies at Intermediate-to-High Risk of Febrile Neutropenia: A Prospective Real-World Study (ESMO 2026) - No abstract available

Clinical • Real-world • Real-world evidence • Chemotherapy-Induced Neutropenia • Hematological Malignancies • Oncology

Telpegfilgrastim in Elderly Patients with Non-Hodgkin Lymphoma for Primary Prophylaxis of Chemotherapy-Induced Neutropenia: A Prospective Study (ESMO 2026) - No abstract available

Clinical • Chemotherapy-Induced Neutropenia • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Efficacy and safety of telpegfilgrastim in breast cancer patients undergoing (neo)adjuvant chemotherapy for prophylaxis of chemotherapy-induced neutropenia: A multicenter, prospective, observational study (ESMO 2026) - No abstract available

Clinical • Observational data • Breast Cancer • Chemotherapy-Induced Neutropenia • Oncology • Solid Tumor

A Pilot Study of Telpegfilgrastim for Prevention of Chemotherapy-Induced Neutropenia in Pediatric Patients with Non-Myeloid Tumors (ESMO 2026) - No abstract available

Clinical • Chemotherapy-Induced Neutropenia • Oncology

Musculoskeletal pain, neutrophil recovery kinetics, and exploratory immune-profiling with telpegfilgrastim versus other long-acting G-CSFs in breast cancer: TELEGRAM (ESMO 2026) - No abstract available

Breast Cancer • Oncology • Solid Tumor

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. (PubMed, EClinicalMedicine) - "Patients received subcutaneous pegfilgrastim, mecapegfilgrastim, telpegfilgrastim, or efbemalenograstim alfa once per cycle per clinical practice...Larger prospective studies are needed to confirm these exploratory findings. None."

Journal • Observational data • Breast Cancer • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Hematological Disorders • Leukopenia • Musculoskeletal Pain • Neutropenia • Oncology • Pain • Solid Tumor

Study on the Safety and Efficacy of Tripegfilgrastim Injection in Pediatric Patients with Non-Myeloid Malignancies Undergoing Chemotherapy (ChiCTR) - P=N/A | N=24 | Not yet recruiting | Sponsor: Bejing Tongren Hospital, Capital Medical Uniersity; Bejing Tongren Hospital, Capital Medical Uniersity

New trial • Neutropenia • Oncology • Pediatrics

STUDY OF TELPEGFILGRASTIM EFFICACY/SAFETY FOR NEUTROPENIA PREVENTION DURING BIWEEKLY CHEMOTHERAPY IN NEOADJUVANT BREAST CANCER (MASCC-ISOO 2026) - "Conversely, among 12 patients in the secondary prophylaxis group (48 cycles), five cycles developed grade ≥3 CIN.All 12 patients who received four consecutive cycles of telpegfilgrastim remained free from grade ≥3 CIN, FN, or serious adverse events.Furthermore, in every telpegfilgrastim-treated cycle, absolute neutrophil count (ANC) recovered to the normal range before subsequent chemotherapy(figure 2, with no evidence of excessive bone marrow stimulation. Conclusions Telpegfilgrastim shows excellent efficacy and a reassuring safety profile for preventing neutropenia in breast-cancer patients receiving dd-EC based (bi-weekly) chemotherapy; subgroup analysis indicates even better outcomes when used as primary prophylaxis."

Clinical • Breast Cancer • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Musculoskeletal Pain • Neutropenia • Oncology • Solid Tumor

A REAL-WORLD, RETROSPECTIVE, OBSERVATIONAL STUDY ON THE EFFICACY AND SAFETY OF TELPEGFILGRASTIM FOR PROPHYLACTIC USE IN ONCOLOGY PATIENTS (MASCC-ISOO 2026) - "Notably, all nine patients with prior intolerance to conventional PEG-rhG-CSFs (manifesting as bone pain/fatigue) experienced complete resolution of these symptoms after switching to telpegfilgrastim (Figure 7). Conclusions Real-world study confirms telpegfilgrastim effective and well-tolerated for CIN/FN prophylaxis, especially benefiting elderly and PEG-rhG-CSF-intolerant patients; larger trials needed to assess long-term ANC prognostic value."

Observational data • Real-world • Real-world evidence • Retrospective data • Breast Cancer • Chemotherapy-Induced Neutropenia • Hematological Malignancies • Lung Cancer • Musculoskeletal Pain • Neutropenia • Solid Tumor

Efficacy and safety of telpegfilgrastim in the prophylaxis of chemotherapy-induced neutropenia in breast cancer patients: A retrospective study. (ASCO 2026) - "Telpegfilgrastim effectively prevented the occurrence of grade 3/4 neutropenia in breast cancer patients undergoing chemotherapy, reduced the incidence of infections and the use of antibiotics, with good safety. These data support Telpegfilgrastim as a feasible option for CIN prevention in clinical practice."

Retrospective data • Breast Cancer • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Infectious Disease • Musculoskeletal Pain • Neutropenia • Oncology • Solid Tumor

Telpegfilgrastim vs Filgrastim for Secondary Prevention of Chemotherapy-Induced Neutropenia in Pediatric Solid Tumors (clinicaltrials.gov) - P2 | N=132 | Recruiting | Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting ➔ Recruiting

Enrollment open • Chemotherapy-Induced Neutropenia • Hematological Disorders • Neutropenia • Oncology • Pediatrics • Solid Tumor

Safety, Tolerability, and PK/PD of Telpegfilgrastim Injection in Non-pregnant Females of Childbearing (clinicaltrials.gov) - P1 | N=18 | Completed | Sponsor: Xiamen Amoytop Biotech Co., Ltd. | Recruiting ➔ Completed | N=30 ➔ 18 | Trial primary completion date: Aug 2025 ➔ Jan 2026

Enrollment change • Trial completion • Trial primary completion date • Gynecology • IL4

ZAP trial: MRD-guided chemotherapy and maintenance de-escalation with zanubrutinib-g-CHOP in high-risk FL (Phase II) (ASH 2025) - P2 | "Background : Patients with untreated follicular lymphoma (FL) and intermediate-high risk FLIPI scores (≥2)face poor outcomes: 5-year PFS is ~50% with standard G-CHOP plus 2-year obinutuzumab maintenance,accompanied by significant toxicity (infection, cytopenias, secondary malignancies and quality-of-lifedeterioration)...The phase II ZAP (Zanubrutinib-Adapted Protocol) trial pioneers a response-adapted de-escalation paradigm integrating zanubrutinib into frontline therapy, aiming to maximize earlymolecular remissions while reducing treatment burden in this vulnerable population. From April 2024 to December 2024, this phase II trial (NCT06474481) enrolled 32 untreated FLpatients (FLIPI 2-5) receiving 4 cycles of zanubrutinib (160mg BID) + standard G-CHOP with mandatorypegfilgrastim prophylaxis... The ZAP trial demonstrates that zanubrutinib-enhanced G-CHOP induces high CR (84.4%) andMRD negativity (>90%) rates in high-risk FL, enabling early chemotherapy..."

Clinical • P2 data • Atrial Fibrillation • Cardiovascular • Febrile Neutropenia • Follicular Lymphoma • Hematological Malignancies • Infectious Disease • Lymphoma • Neutropenia

Efficacy and safety of telpegfilgrastim in the prevention of neutropenia following chemotherapy for non-myeloid tumors: A retrospective study (ESMO Asia 2025) - "All patients received 2mg of pegfilgrastim 24 hours after chemotherapy drug administration. Telpegfilgrastim holds advantages in preventing CIN, demonstrating favorable efficacy and safety. The incidence of grade 3/4 CIN was only 7.8% and FN was 0%. Telpegfilgrastim also has a long-lasting protective effect of ANC to ensure the normal progress of treatment."

Retrospective data • Chemotherapy-Induced Neutropenia • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Oncology • Solid Tumor

A real-world, retrospective, observational study on the efficacy and safety of telpegfilgrastim for prophylactic use in oncology patients [WITHDRAWN] (ESMO Asia 2025) - No abstract available

Observational data • Real-world • Real-world evidence • Retrospective data • Oncology

Efficacy and Safety of Telpegfilgrastim in the Prophylaxis of Chemotherapy-Induced Neutropenia in Patients with Lymphoma: A Retrospective Study (ASH 2024) - "The drug exhibited favorable safety profiles. These findings suggest that telpegfilgrastim is a promising alternative to traditional PEG-rhG-CSF prophylaxis in lymphoma patients."

Retrospective data • Breast Cancer • Chemotherapy-Induced Neutropenia • Fatigue • Febrile Neutropenia • Infectious Disease • Leukopenia • Lung Cancer • Lymphoma • Musculoskeletal Pain • Neutropenia • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Pain • Solid Tumor

Exploratory study on the reduction of granulosa cell apoptosis by colony cell stimulating factor preconditioning in elderly patients with low reserve (ChiCTR) - P4 | N=90 | Sponsor: Chongqing Health Center for Women and Children; Chongqing Health Center for Women and Children

New P4 trial • BAX • BCL2 • CASP3

Phase 3 Study to Evaluate the Safety and Efficacy of YPEG-rhG-CSF in Malignancies Receiving Chemotherapy (clinicaltrials.gov) - P3 | N=398 | Completed | Sponsor: Xiamen Amoytop Biotech Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Dec 2022 ➔ Sep 2021 | Trial primary completion date: Jun 2022 ➔ Jun 2021

Trial completion • Trial completion date • Trial primary completion date • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Phase 3 Study to Evaluate the Safety and Efficacy of YPEG-rhG-CSF in Malignancies Receiving Chemotherapy (clinicaltrials.gov) - P3; N=375; Recruiting; Sponsor: Xiamen Amoytop Biotech Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Breast Cancer • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology