Evive Biotech`s Biologic Ryzneuta (efbemalenograstim alpha) Receives Approval in the U.S.
Evive Biotech, a global biopharmaceutical company devoted to developing novel biologic therapies and a subsidiary of Yifan Pharmaceutical Co. Ltd., has entered into a license agreement with Acrotech Biopharma (Acrotech), a New Jersey-based and wholly-owned subsidiary of Aurobindo Pharma USA Inc., to commercialize Ryzneuta (Efbemalenograstim alfa) in the US.
Aurobindo Pharma on Wednesday said its unit has entered into a licensing pact with Evive Biotech to commercialise Ryzneuta in the US market. The product, a novel dimeric G-CSF long-acting fusion protein without pegylation, is currently under late-stage review by the US Food and Drug Administration for chemotherapy-induced neutropenia (CIN).
SINGAPORE, March 31, 2021 /PRNewswire/ -- Evive Biotech, a global biologics company developing novel biologic therapies, today announced the submission of its Biologics License Application (BLA) for Ryzneuta™ (also known as F-627) to the US Food & Drug Administration (FDA). The submission follows the successful conclusion of Evive's Global Phase III Clinical Trials (NCT03252431 and NCT02872103), which met its primary and secondary endpoints, demonstrating strong and lasting benefit for patients.