China-based Yifan Pharmaceutical Co., Ltd (SHE: 002019) has announced that its subsidiary, Evive Biotech Ltd., has received Biologic License Application (BLA) approval from the US Food and Drug Administration (FDA) for Ryzneuta (efbemalenograstim alfa, F-627). The drug is indicated to reduce the incidence of infection manifested as febrile neutropenia in adult patients with non-myeloid malignant tumors when receiving bone marrow suppressive anticancer drugs that are prone to causing febrile neutropenia.
F-627: A Potential First-in-Class rhG-CSF with Global Licensing Deals
F-627, a potential first-in-class recombinant human granulocyte colony-stimulating factor (rhG-CSF), has been developed using the proprietary Di-Kine bimolecular technology platform. The drug is known for its long-lasting and potent biological characteristics. Yifan Pharma has secured multiple licensing deals for F-627, reflecting its global commercial potential. In August 2021, the company granted commercialization rights in mainland China to Chia Tai Tianqing for RMB 210 million (USD 29.75 million). Subsequent deals included distribution rights in Greece and Cyprus to KALTEQ S.A. for USD 6.6 million in January 2022, rights in Germany to Apogepha for USD 38.9 million in February 2022, rights in Brazil to LIBBS FARMACÊUTICA LTDA for USD 6.7 million in March 2022, and rights in Switzerland to Apogepha Arzneimittel GmbH for USD 6.97 million one month later. The drug received approval in China in May 2023.- Flcube.com
