‘Ryzneuta’ by Aurobindo Pharma receives FDA nod

New Jersey: Evive Biotech (Evive), and Acrotech Biopharma have jointly revealed a groundbreaking achievement—the FDA's seal of approval for Ryzneuta™ (Efbemalenograstim alfa Injection) in the treatment of Chemotherapy-Induced Neutropenia (CIN). This milestone marks Ryzneuta™ as the pioneering non-pegylated granulocyte colony-stimulating factor sanctioned by both the FDA and China's NMPA, specifically tailored to address CIN in adults undergoing myelosuppressive anti-cancer treatments. By aiming to diminish infection rates, including the prevalent febrile neutropenia, a common fallout of chemotherapy, Ryzneuta™ emerges as a promising solution.

Evive Biotech, is a subsidiary of Yifan Pharmaceutical Co. Ltd., and Acrotech Biopharma (Acrotech), is a New Jersey-based and wholly-owned subsidiary of Aurobindo Pharma USA Inc.

Neutropenia is a common side effect of chemotherapy and is characterized by persistently low levels of neutrophils (a type of white blood cell with infection-fighting functions) due to the use of chemotherapy and other types of anti-cancer drugs, which increases the risk of adverse reactions such as infection and fever in cancer patients during chemotherapy. Ryzneuta™ is a novel dimeric G-CSF long-acting fusion protein without PEGylation or Tween-80. Due to its unique molecular structure, Ryzneuta™ may possess stronger G- CSF receptor activation properties and avoid the potential problem (such as allergic reactions) caused by PEG or Tween-80.

The FDA approval, hinged upon exhaustive Phase 3 studies conducted across diverse regions in the US and Europe, unequivocally endorses the efficacy and safety profile of Ryzneuta™ in comparison to its counterpart, Neulasta™. Noteworthy is Ryzneuta™'s distinctive composition—a novel, prolonged-action Granulocyte colony-stimulating factor devoid of PEGylation or Tween-80. This unique formulation holds the promise of heightened activation of G-CSF receptors, potentially circumventing certain side effects typically associated with similar medications.

Simon Li, the astute CEO & CMO of Evive, underlined this approval as a testament to the adeptness of their team in navigating the complexities of global biologics development—from the meticulous realms of research and regulatory compliance to the intricate landscapes of manufacturing and eventual commercialization. The collaborative efforts of Evive and Acrotech are poised to break barriers and facilitate broader access to this innovative treatment for a larger cohort of CIN-afflicted patients within the United States.

“Acrotech is very excited on the approval of Ryzneuta™ and is preparing to commercialize the product in the near future. We believe Ryzneuta™ will offer patients suffering from CIN a very compelling and accessible treatment option. We will leverage our strong and well- established commercial footprint to promote this unique treatment to key stakeholders.” said Dr. Ashish Anvekar, President of Acrotech Biopharma.

In May this year, Ryzneuta® was approved and launched in China. In addition, the facility producing Ryzneuta® has successfully passed the on-site GMP inspections conducted by ANVISA and EMA. In the near future, Ryzneuta® is expected to receive more regulatory approvals.