Evive Enters License Agreement with Acrotech Biopharma to Commercialize Ryzneuta™ in the United States

Evive Biotech (Evive), a global biopharmaceutical company devoted to developing novel biologic therapies and a subsidiary of Yifan Pharmaceutical Co. Ltd., 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).

"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 RyzneutaTM 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.

Shares of Aurobindo Pharma Limited was last trading in BSE at Rs. 460.70 as compared to the previous close of Rs. 463.85. The total number of shares traded during the day was 62400 in over 2688 trades.

The stock hit an intraday high of Rs. 466.45 and intraday low of 459.05. The net turnover during the day was Rs. 28786703.00.

Source : Equity Bulls

Keywords

AurobindoPharma INE406A01037 EviveBiotech US LicenseAgreement AcrotechBiopharma Ryzneuta Efbemalenograstimalfa