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

Guard-01: A prospective study of efbemalenograstim alfa as primary prophylaxis for concurrent chemo-radiotherapy induced neutropenia. (ASCO 2025) - P4 | "Clinical Trial Registration Number: ChiCTR2300077504 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Hematological Disorders • Neutropenia • Oncology

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) - P4 | "Clinical Trial Registration Number: ChiCTR2300078792 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Breast Cancer • Oncology • 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 | "Clinical Trial Registration Number: NCT06143735 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Febrile Neutropenia • Hematological Disorders • Lung Cancer • 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 | "Clinical Trial Registration Number: NCT06251947 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

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

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

Efbemalenograstim alfa not inferior to pegfilgrastim in providing neutrophil support in women with breast cancer undergoing myelotoxic chemotherapy: results of a phase 2 randomized, multicenter, open-label trial. (PubMed, Support Care Cancer) - P2 | "Efbemalenograstim alfa was comparable to pegfilgrastim in efficacy and safety."

Journal • P2 data • Breast Cancer • Febrile Neutropenia • Hematological Disorders • Neutropenia • Oncology • Solid Tumor

Efbemalenograstim alfa, an Fc fusion protein, long-acting granulocyte-colony stimulating factor for reducing the risk of febrile neutropenia following chemotherapy: results of a phase III trial. (PubMed, Support Care Cancer) - P3 | "Efbemalenograstim alfa is effective and safe for significantly decreasing the duration of severe neutropenia and the incidence of febrile neutropenia in breast cancer patients who are receiving TA chemotherapy."

Clinical • Journal • P3 data • Breast Cancer • Febrile Neutropenia • Hematological Disorders • Neutropenia • Oncology • Solid Tumor

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) and the NCCN Drugs & Biologics Compendium (NCCN Compendium) for Hematopoietic Growth Factors, Version 2.2024. (NCCN)

NCCN guideline • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Oncology

Evive, Acrotech get FDA nod for Ryzneuta (Efbemalenograstim alfa Injection) for chemo-induced neutropenia (ExpressPharma) - "Evive Biotech...announced that the US Food and Drug Administration (FDA) approved Ryzneuta (Efbemalenograstim alfa) indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. The approval was based on results of the two Phase 3 trials, Study GC-627-04 [NCT02872103] and Study GC-627-05 [NCT03252431] completed in the US and Europe."

sBLA • Chemotherapy-Induced Neutropenia • Oncology

A Study of Efbemalenograstim Alfa Injection for Stage IIIB or IV NSCLC Recieving Moderate-risk Febrile Neutropenia (FN) Chemotherapy Regimen With Risk Factors (clinicaltrials.gov) - P2 | N=99 | Not yet recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital

New P2 trial • Febrile Neutropenia • Hematological Disorders • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Efbemalenograstim Alfa: First Approval. (PubMed, Drugs) - "Efbemalenograstim alfa is under regulatory review for the management of chemotherapy-induced neutropenia in the EU and the USA. This article summarizes the milestones in the development of efbemalenograstim alfa leading to this first approval for the management of chemotherapy-induced neutropenia."

Journal • Review • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Neutropenia • Oncology • Solid Tumor

The impact of new and emerging agents on outcomes for febrile neutropenia: addressing clinical gaps. (PubMed, Curr Opin Oncol) - "Multiple emerging agents show promise in decreasing the burden of CIN. Use of these therapies will reduce access disparities and will improve outcomes for patients with cancer receiving cytotoxic chemotherapy. Many ongoing trials are underway to evaluate the roles of these agents for more widespread use."

Journal • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Neutropenia • Oncology

China Biopharma (01177): The innovative drug "F-627 (efbemalenograstim α Injection)" was approved for marketing [Google traslation] (Zhitong Finance) - "Zhitong Finance APP News, Sino Biopharmaceutical (01177) announced that the Class 1 innovative drug 'F-627 (efbemalenograstim α Injection)' (Chinese trade name: Yilishu) jointly developed by the group has been approved by China Approved by the State Drug Administration for the prevention and treatment of neutropenia in tumor patients after receiving chemotherapy drugs....This approval is based on the pivotal phase III trials of three multi-center, randomized, controlled studies completed by Yilishu in the world, comparing Yilishu with the currently commonly used short-acting whitening drug filgrastim (Neupogen) in clinical practice."

Non-US regulatory • Chemotherapy-Induced Neutropenia • Oncology

A Phase III, Randomized, Multi-Center, Open-Label, Fixed Dose, Neulasta Active-Controlled Clinical Trial of F-627, a Novel G-CSF, in Women with Breast Cancer Receiving Myelotoxic Chemotherapy (ASH 2021) - "Ryzneuta TM (F-627), a recombinant fusion protein containing human granulocyte-colony stimulating factor (G-CSF) and IgG2-Fc fragment, is intended to reduce CIN by utilizing the neutrophilic proliferating and activating properties of G-CSF...Methods - This was a phase III, multi-center, randomized, open-label, two-arm, active-controlled study that randomized female patients with Stage I to III invasive breast cancer who received 4 cycles of myelotoxic taxane + cyclophosphamide chemotherapy treatment...F-627 was well tolerated during the study with an overall safety profile comparable to that for Neulasta®. F-627 is a safe, effective, and easy to use alternative to current CIN therapy."

Clinical • P3 data • Breast Cancer • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Hematological Disorders • Infectious Disease • Neutropenia • Oncology • Solid Tumor • CSF3 • CSF3R