Aurobindo Pharma USA arm, Evive Biotech ink pact for commercialisation of Ryzneuta in US
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.
New Jersey: Acrotech Biopharma, a New Jersey-based and wholly-owned subsidiary of Aurobindo Pharma USA Inc., has entered into a license agreement with Evive Biotech, a subsidiary of Yifan Pharmaceutical Co. Ltd., 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).
"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, M.D., Ph.D., CEO & CMO of 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 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.
"We are very excited to partner with Evive to bring this valuable therapeutic option to patients. Ryzneuta provides Acrotech Biopharma the opportunity to expand its offerings to oncology patients and is aligned with our vision of commercializing scientifically advanced products. Additionally, expanding into CIN creates future growth opportunities for us," said Dr. Ashish Anvekar, President of Acrotech Biopharma. "We believe Ryzneuta will offer patients suffering from CIN a very compelling and accessible treatment option."
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, Evive's Marketing Authorization Application (MAA), and New Drug Application (NDA) for Ryzneuta are currently under review by European and Chinese regulators.
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