To commercialise Ryzneuta (Efbemalenograstim alfa) in the US
Evive Biotech (Evive), a global biopharmaceutical company devoted to developing novel biologic therapies and a subsidiary of Yifan Pharmaceutical Co, has entered into a license agreement with Acrotech Biopharma (Acrotech), a New Jersey-based and wholly-owned subsidiary of Aurobindo Pharma USA to commercialise Ryzneuta (Efbemalenograstim alfa) in the US.
Ryzneuta is a novel dimeric G-CSF 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).
“Despite the current options, CIN remains a significant clinical condition for most cancer patients, creating the need for more potent and convenient treatment. Due to its unique molecular structure, Ryzneuta may possess stronger G-CSF receptor activation properties.
Additional clinical trials are being planned to demonstrate improved clinical efficacy of Ryzneuta,” said Simon Li, CEO and CMO, Evive. “Acrotech has proven and strong capacity to commercialize proprietary medications, we look forward to partnering with them for bringing this novel medicine to more cancer patients with CIN in the US.”
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 characterised 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, the EU and China.
In addition to the BLA submitted to USFDA, Evive’s Marketing Authorization Application (MAA), and New Drug Application (NDA) for Ryzneuta are currently under review by European and Chinese regulators.