Tanvex BioPharma USA, Inc. Achieves Dual U.S. Regulatory Milestones: FDA Approves Nypozi(TM) and FDA Accepts Biosimilar Biologics License Application for TX-05

Tanvex BioPharma USA, Inc. ("Tanvex") has announced two significant regulatory milestones. The U.S. FDA has approved NYPOZI™ (filgrastim-txid), a biosimilar referencing Neupogen®. This drug treats chemotherapy-induced neutropenia in cancer patients. Additionally, the FDA has accepted Tanvex's Biologics License Application (BLA) for TX-05, an investigational biologic targeting HER2-positive cancers, proposed as a biosimilar to Herceptin®.

John Mosack, Chief Operating Officer, highlighted the importance of these milestones. NYPOZI™ provides a critical treatment option. The acceptance of the TX-05 BLA underscores Tanvex's commitment to high-quality biologics manufacturing.

NYPOZI™ was approved for various indications, including reducing severe neutropenia in cancer patients undergoing chemotherapy. Neutropenia affects 60,000 to 100,000 cancer patients in the U.S. annually, increasing the risk of infections and impacting treatment schedules.

Henry Chen, Chairman and CEO, acknowledged the contributions of patients, scientists, and collaborators. Tanvex aims to increase access to effective therapies, benefiting numerous individuals dealing with neutropenia as part of their cancer care.