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."
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