Evive Biotech, a global biopharmaceutical company and a subsidiary of Yifan Pharmaceutical Co. Ltd., along with New Jersey-based Acrotech Biopharma, a wholly-owned subsidiary of Aurobindo Pharma USA Inc., announced the U.S. Food and Drug Administration (FDA) approval of Ryzneuta (Efbemalenograstim alfa). The medication is indicated to decrease the incidence of infection as manifested by febrile neutropenia in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs.

Clinical Studies and Treatment Efficacy

The FDA approval is grounded on results from two pivotal Phase 3 studies – GC-627-04 and GC-627-05 conducted in the United States and Europe. Ryzneuta, a novel long-acting Granulocyte colony-stimulating factor (G-CSF), is designed to enhance the immune function of cancer patients and prevent neutropenia side effects caused by chemotherapy. Study GC-627-05, a multi-center, randomized, multi-dose, active-controlled study, demonstrated the efficacy and safety of Ryzneuta compared to Neulasta (Pegfilgrastim).

Neutropenia and Ryzneuta’s Unique Composition

Neutropenia, a common chemotherapy side effect, is characterized by low levels of neutrophils, increasing the risk of infection and fever in cancer patients. Ryzneuta, a novel dimeric G-CSF long-acting fusion protein without PEGylation or Tween-80, may offer stronger G-CSF receptor activation properties and avoid potential allergic reactions.

Statements from Evive Biotech and Acrotech Biopharma Leaders

Dr. Simon Li, CEO & CMO of Evive, emphasized the company’s capability in the global development of innovative biologics, including Ryzneuta. Dr. Ashish Anvekar, President of Acrotech Biopharma, expressed excitement about the approval and commercialization plans for Ryzneuta in the U.S.

Global Impact and Future Prospects

Ryzneuta was approved and launched in China earlier this year. The manufacturing facility for Ryzneuta has successfully passed GMP inspections by ANVISA and EMA, and more regulatory approvals are anticipated. This development positions Ryzneuta to provide effective first-line treatment and alternative therapy for cancer patients globally.

  Acrotech Biopharma, Aurobindo Pharma, cancer, Dr. Ashish Anvekar, Dr. Simon Li, Efbemalenograstim alfa, Evive Biotech, febrile neutropenia, Ryzneuta, US FDA, USA