Pegneugen (telpegfilgrastim) / Xiamen Amoytop Biotech - LARVOL DELTA

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observational study on the efficacy and safety of telpegfilgrastim for prophylactic use in oncology patients [WITHDRAWN] (ESMO Asia 2025) - No abstract available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