Ryzneuta (efbemalenograstim alpha) / Yifan Pharma, Sino Biopharm - LARVOL DELTA

Efbemalenograstim alfa as primary prophylaxis for concurrent chemo-radiotherapy induced neutropenia: Guard-01 results (ESMO Asia 2025) - P4 | "Subgroup analysis by regimen showed consistent benefit, with significant difference in paclitaxel- or pemetrexed- based subgroups (21.74% vs. 70.83%, p=0.0007). Efbemalenograstim alfa provides effective prophylaxis against grade 3/4 neutropenia in patients undergoing CCRT with a favorable safety profile."

Chemotherapy-Induced Neutropenia • Oncology

Efbemalenograstim alfa significantly reduces incidence of incidence of severe chemotherapy-induced neutropenia in later cycles: Results of a meta analysis (SABCS 2025) - " ISN rates from four cycles from phase III trials of efbemalenograstim alfa and three different chemotherapy regimens, docetaxel + cyclophosphamide (TC) (Trial 1), epirubicin + cyclophosphamide (EC) (Trial 2), and high myelotoxic docetaxel + doxorubicin (TA) (Trial 3 + historic pegfilgrastim and filgrastim comparative data) were evaluated. Across studies, non-PEGylated efbemalenograstim alfa has demonstrated equivalent or lower incidence rates of severe neutropenia (grade 4, ANC <0.5 × 109/L) during the first cycle of three types of chemotherapy (TC, EC and TA) and importantly, significantly lower rates in later cycles when compared to pegfilgrastim and filgrastim. These findings demonstrate that efbemalenograstim alfa may be more effective at preventing severe, life-threatening neutropenia at later chemotherapy cycles, which has meaningful implications for real-world breast cancer patients that are likely to receive chemotherapy for longer durations."

Retrospective data • Breast Cancer

Guard-02: Efficacy and safety of same-day long-acting G-CSF (Efbemalenograstim alfa) for neutropenia prevention in breast cancer patients (ESMO 2025) - P4 | "Methods This prospective, multicenter, single-arm, two-stage clinical trial enrolled 52 breast cancer patients scheduled to receive EC chemotherapy (epirubicin 90 mg/m 2 + cyclophosphamide 600 mg/m 2 ) for four cycles. Legal entity responsible for the study Anhui Provincial Cancer Hospital, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Anhui Provincial Hospital. Funding Has not received any funding."

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

Efbemalenograstim Alfa, an Fc Fusion Protein, Long‑Acting Granulocyte Colony-Stimulating Factor for Reducing the Risk of Chemotherapy-Induced Neutropenia: Results of a Phase II Randomized, Multicenter, Open‑Label Trial. (PubMed, Clin Drug Investig) - P2 | "The efficacy and safety of efbemalenograstim alfa are comparable to those of filgrastim in treating chemotherapy-induced neutropenia in patients with breast cancer receiving EC chemotherapy. Efbemalenograstim alfa at a dose of 20 mg is the recommended dose for phase III clinical trials."

Journal • P2 data • Back Pain • Breast Cancer • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Hematological Disorders • Musculoskeletal Pain • Neutropenia • Oncology • Pain • Solid Tumor

Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Efbemalenograstim Alfa (F-627), a Novel Long-Acting rhG-CSF, in Healthy Chinese Participants: An Open-Label, Single-Center Phase I Study. (PubMed, Clin Drug Investig) - P1 | "This phase I study showed that 20 mg F-627 was well tolerated and exhibited a favorable safety profile in a healthy Chinese population. The PK and PD data correlated well and were consistent across sex."

Journal • P1 data • PK/PD data • Infectious Disease

Ryzneuta® - erster PEG-freier G-CSF. (PubMed, MMW Fortschr Med) - No abstract available

Journal

Efbemalenograstim Alfa for Primary/Secondary Prevention in Patients With Solid Tumors at High Risk for Febrile Neutropenia (FN) or Intermediate Risk of Chemotherapy Regimens Associated With Other Risk Factors in FN (clinicaltrials.gov) - P2 | N=1076 | Recruiting | Sponsor: Henan Cancer Hospital

New P2 trial • Febrile Neutropenia • Hematological Disorders • Neutropenia • Solid Tumor

Efbemalenograstim Alpha Prophylaxis for Intermediate-Risk FN Chemotherapy in NSCLC: A Multicenter Exploratory Study (IASLC-WCLC 2025) - P2 | "The secondary objectives included FN incidence, grade ≥3 neutropenia during other chemotherapy cycles, and adverse events or serious adverse events. Here,we present, after the first analysis, the updated results of Guard-03."

Clinical • Febrile Neutropenia • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Solid Tumor

EFFICACY AND SAFETY OF EFBEMALENOGRASTIM ALFA IN THE TREATMENT OF NEUTROPENIA INDUCED BY RCHOP-LIKE REGIMENS IN NEWLY DIAGNOSED NON-HODGKIN'S LYMPHOMA PATIENTS: A RANDOMIZED CONTROLLED MULTICENTER CLINICAL STUDY (EHA 2025) - P4 | "Efbemalenograstim a is anovelong-acting G-CSF approved by FDA in 2023, but there have been no reported data on its use in newly diagnosed non-Hodgkin's lymphoma patients to date. Using efbemalenograstim alfa for the primary prophylaxis of neutropenia induced by R-CHOP-like treatment regimens in patients with newly diagnosed non-Hodgkin's lymphoma is effective and safe."

Clinical • Back Pain • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Lymphoma • Musculoskeletal Pain • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Pain

Guard-01: A prospective study of efbemalenograstim alfa as primary prophylaxis for concurrent chemo-radiotherapy induced neutropenia. (ASCO 2025) - P4 | "Among 14 patients receiving etoposide or docetaxel based chemotherapy, two patients (28.57%) in the study group experienced grade 3/4 neutropenia, while four patients (57.14%) in the control group did. For 23 patients receiving paclitaxel or pemetrexed based chemotherapy, grade 3/4 neutropenia was observed in two patients (16.67%) of the study group, compared to seven (63.64%) of the control group. The incidence of grade 3/4 neutropenia in the 35 patients receiving cisplatin mono-chemotherapy was 5.88% (one patient) and 22.22% (four patients) in the study and control groups, respectively... Efbemalenograstim alfa is safe and efficacious in preventing grade 3/4 neutropenia in patients undergoing CCRT."

Clinical • Anemia • Febrile Neutropenia • Hematological Disorders • Leukopenia • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia

Guard-02: Safety and efficacy of prophylactic use of novel long-acting G-CSF efbemalenograstim α on same-day of chemotherapy in breast cancer patients. (ASCO 2025) - P3, P4 | "Breast cancer patients who received chemotherapy with epirubicin (90 mg/m2) and cyclophosphamide (600 mg/m2) (EC therapy) for 4 cycles were enrolled. Administering long-acting G-CSF on same-day of chemotherapy was as safe and effective as on day 3 of chemotherapy in reducing the risk of CIN. In patients with daytime chemotherapy, efbemalenograstim α provides oncologists an alternative for simplifying the management of CIN. Summary of efficacy endpoints by cycle."

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

Efbemalenograstim alfa for the primary/secondary prophylaxis of intermediate-risk febrile neutropenia (FN) chemotherapy regimen with risk factors in patients with non-small cell lung cancer (NSCLC): A randomized, multicenter, exploratory clinical trial. (ASCO 2025) - P2 | "Efbemalenograstim alfa demonstrated promising clinical efficacy in the prophylactic management of chemotherapy-induced neutropenia, reducing the risk of infection and enhancing patients' quality of life"

Clinical • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Hematological Disorders • Infectious Disease • Lung Cancer • Musculoskeletal Pain • Neutropenia • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Efbemalenograstim alfa for primary prophylaxis of chemotherapy-induced neutropenia in patients with ovarian and cervical cancer: A single-arm, multicenter clinical trial. (ASCO 2025) - P2 | "All patients were scheduled to receive 3-6 cycles of chemotherapy regimen (Paclitaxel + Carboplatin/Cisplatin ± Bevacizumab). A single fixed dose of 20 mg of efbemalenograstim alfa was proved to be safe and effective in reducing chemotherapy-induced neutropenia and its complications in patients who received Chemotherapy. Efbemalenograstim alfa provides an alternative for patients with chemotherapy-induced neutropenia."

Clinical • Anemia • Cervical Cancer • Chemotherapy-Induced Neutropenia • Fallopian Tube Cancer • Febrile Neutropenia • Hematological Disorders • Leukopenia • Neutropenia • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • Thrombocytopenia

Efficacy and safety of efbemalenograstim alfa as primary prophylaxisfor concurrent chemo-radiotherapy induced neutropenia (AACR 2025) - "Primary prophylaxis with efbemalenograstim alfa provide effective neutrophil support to patients undergoing CCRT, with good safety."

Clinical • Cervical Cancer • Esophageal Cancer • Head and Neck Cancer • Lung Cancer • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CSF2

Safety and efficacy of same-day administration of novel long-acting G-CSF efbemalenograstim α in breast cancer patients undergoing cytotoxic chemotherapy (AACR 2025) - P3, P4 | "Breast cancer patients received chemotherapy with epirubicin (90 mg/m2) and cyclophosphamide (600 mg/m2) for 4 cycles were enrolled. Using long-acting G-CSF on same-day of chemotherapy was as safe and effective as on d3 of chemotherapy in reducing CIN. In patients with daytime chemotherapy, efbemalenograstim α provides oncologists an alternative for simplifying management of CIN.Cycle 1-2Cycle 1Cycle 2Cycle 3Cycle 4Cycle 1-4The incidence of grade 3-4 neutropenia in each cycle (n/N, %)4/16(25.00)1/16 (6.25)3/16 (18.75)1/16 (6.25)1/16 (6.25)5/16 (31.25)The incidence of grade 4 neutropenia in each cycle, (n/N, %)1/16 (6.25)0/16 (0.00)1/16 (6.25)0/16 (0.00)1/16 (6.25)2/16 (12.50)The incidence of febrile neutropenia (FN) in each cycle, (n/N, %)1/16 (6.25)0/16 (0.00)1/16 (6.25)0/16 (0.00)0/16 (0.00)1/16 (6.25)The duration of grade 3-4 neutropenia in each cycle (median[95% CI], days)0 (0, 0)0 (0, 0)0 (0, 0)0 (0, 0)0 (0, 0)0 (0, 1)"

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

Efbemalenograstim Alfa for Primary Prophylaxis of Chemotherapy-Induced Neutropenia In Patients With Ovarian and Cervical Cancer: A Single-Arm, Multicenter Clinical Trial (SGO 2025) - No abstract available

Clinical • Cervical Cancer • Chemotherapy-Induced Neutropenia • Oncology • Ovarian Cancer • Solid Tumor

EF-001: A Multi-cohort Study of Efbemalenograstim Alfa Injection for Preventing ANC Reduction in Solid Tumor Patients Post Immune-chemotherapy. (clinicaltrials.gov) - P=N/A | N=200 | Not yet recruiting | Sponsor: Shandong Cancer Hospital and Institute

New trial • Chemotherapy-Induced Neutropenia • Esophageal Squamous Cell Carcinoma • Hematological Disorders • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A randomized, multicenter phase III Study of once-per-cycle administration of efbemalenograstim alfa (F-627), a novel long-acting rhG-CSF, for prophylaxis of chemotherapy-induced neutropenia in patients with breast cancer. (PubMed, BMC Cancer) - P3 | "A single fixed dose of 20 mg of F-627 in each cycle was as safe and effective as a daily dose of filgrastim 5 µg/kg/d in reducing neutropenia and its complications in patients who received four cycles of EC."

Clinical • Journal • P3 data • Breast Cancer • Chemotherapy-Induced Neutropenia • Hematological Disorders • Neutropenia • Oncology • Solid Tumor

Ryzneuta for prevention of febrile neutropenia. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Febrile Neutropenia • Hematological Disorders • Neutropenia

Guard 01: A randomized, multicentre, controlled trail on the prophylactic use of efbemalenograstim alfa for concurrent chemo-radiotherapy induced neutropenia. (ASCO 2024) - "The primary endpoint is the incidence of grade ≥3 neutropenia (ANC<1.0×10 9 /L) during concurrent chemo-radiotherapy. The trial is opened in November 2023 and will be conducted in 8 hospitals with the aim of recruiting 120 evaluable patients (4 patients are recruited untilled 29-Jan-2024)."

Clinical • Cervical Cancer • Chemotherapy-Induced Neutropenia • Esophageal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hematological Disorders • Infectious Disease • Leukopenia • Lung Cancer • Nasopharyngeal Carcinoma • Neutropenia • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Efbemalenograstim Alfa-vuxw. (PubMed, Am J Health Syst Pharm) - No abstract available

Journal

Efbemalenograstim Alfa Injection for Ovarian or Cervical Cancer Receiving Chemotherapy Regimen (clinicaltrials.gov) - P2 | N=83 | Recruiting | Sponsor: Shandong University | Not yet recruiting ➔ Recruiting

Enrollment open • Cervical Cancer • Neutropenia • Oncology • Ovarian Cancer • Solid Tumor

Study of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy (clinicaltrials.gov) - P1 | N=18 | Completed | Sponsor: EVIVE Biotechnology | Phase classification: P1/2 ➔ P1

Phase classification • Breast Cancer • Hematological Disorders • Neutropenia • Oncology • Solid Tumor

Efbemalenograstim Alfa Injection for Ovarian or Cervical Cancer Receiving Chemotherapy Regimen (clinicaltrials.gov) - P2 | N=83 | Not yet recruiting | Sponsor: Shandong University

New P2 trial • Cervical Cancer • Neutropenia • Oncology • Ovarian Cancer • Solid Tumor

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Hematopoietic Growth Factors, Version 3.2024. (NCCN)

NCCN guideline • Febrile Neutropenia • Solid Tumor