Acrotech Biopharma and Evive Biotech have obtained FDA approval for Ryzneuta® to treat chemotherapy-induced Neutropenia (CIN)

On 16th November 2023, the FDA gave the green light to Ryzneuta® (Efbemalenograstim alfa), a treatment purposed to mitigate the possibility of infection, specifically febrile neutropenia, in mature individuals dealing with non-myeloid malignancies. This approval was declared by Evive Biotech in collaboration with Acrotech Biopharma, noting that the specified patients would be following a course of myelosuppressive anti-cancer medication, with a notable occurrence of febrile neutropenia.

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The endorsement stems from findings of two integral Phase 3 Studies, GC-627-04 and GC-627-05, conducted in the United States and Europe. Ryzneuta® functions as a unique, long-acting Granulocyte colony-stimulating factor (G-CSF), responsible for promoting the growth, diversification, and dispatch of neutrophil progenitors. It enhances the immune capacity of cancer sufferers and counteracts the adverse effects of chemotherapy-induced neutropenia.

The multi-center, randomized, multiple-dose, active-controlled Study GC-627-05 was essentially designed to contrast the efficacy and safety of Ryzneuta® and Neulasta® (Pegfilgrastim). The trial successfully accomplished its primary and secondary objectives regarding efficacy and safety.

Typically, neutropenia is a prevalent chemotherapy side effect, illustrated by chronically low neutrophil counts due to the application of chemotherapy and other anti-cancer medications. This increases the chance of unwanted events such as infections and fever in cancer patients undergoing chemotherapy.

Ryzneuta® is a novel dimetric G-CSF long-acting fusion protein void of PEGylation or Tween-80. Ryzneuta®'s distinct molecular structure may result in enhanced G-CSF receptor activation capabilities, hence bypassing issues potentially brought about by PEG or Tween-80.

As quoted by Simon Li, M.D., Ph.D., CEO & CMO of Evive, "Ryzneuta® represents the first biologics independently created by Evive Biotech, and its endorsement testifies to Evive R&D team's potential for independent global development of innovative biologics". He added, "We are excited about partnering with Acrotech to offer this novel treatment to more CIN sufferers in the US."

Ryzneuta® bolsters the immune system's defense against infection by elevating the production of neutrophils, thwarting possible chemotherapy dose downsizing and interruptions which could undermine treatment results. Progressively, Ryzneuta® anticipates further regulatory authorizations, positioning Ryzneuta® to offer urgently needed, efficacious, first-line treatment and alternative therapy to global cancer patients.

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According to the data provided by the Synapse Database, As of November 30, 2023, there are 183 investigational drugs for the CSF-3R target, including 71 indications, 207 R&D institutions involved, with related clinical trials reaching 1661, and as many as 1338 patents.

Ryzneuta® (Efbemalenograstim alfa) is developed for the treatment of Chemotherapy-Induced Neutropenia in cancer patients after chemotherapy. 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.