Evive enters into license agreement with Acrotech to commercialize Ryzneuta? in US

23 Nov 2022 , 12:05 PM

Evive Biotech (Evive), a global biopharmaceutical company devoted to developing novel biologic therapies and a subsidiary of Yifan Pharmaceutical Co., announced today that it 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. Ryzneuta? is a novel dimeric GCSF long-acting fusion protein without pegylation. The Biologics License Application (BLA) of Ryzneuta? is currently under late-stage review by the US FDA for Chemotherapy-Induced Neutropenia (CIN). Under review by the US FDA, Ryzneuta? is developed for the treatment of CIN in cancer patients after chemotherapy. Neutropenia is a common side-effect of chemotherapy and is a condition characterized by low levels of neutrophils, a type of white blood cell that fights infection. This important partnership builds on the comprehensive global development program of Ryzneuta?, which includes 12 clinical trials and has enrolled over 1,200 subjects to date in multiple territories including the US, EU, and China. Evive will be responsible for the ongoing development, manufacturing, registration, and supply of Ryzneuta?, while Acrotech will use its sales and commercialization capabilities to market and distribute Ryzneuta? in the US. In addition, both companies may conduct additional development of the Product to explore further opportunities for Ryzneuta?. In addition to the BLA submitted to US FDA, Evives Marketing Authorization Application (MAA), and New Drug Application (NDA) for Ryzneuta? are currently under review by European and Chinese regulators. Powered by Capital Market – Live News