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

SAN DIEGO, August 19, 2024 (Newswire.com) – Tanvex BioPharma USA, Inc. (“Tanvex” or the “Company”), a contract development and manufacturing organization (CDMO) for biologics and a biosimilars products company, recently announced that the U.S. Food and Drug Administration (FDA) approved NYPOZI™ (filgrastim-txid), the Company’s biosimilar referencing Neupogen^®,¹ to treat chemotherapy-induced neutropenia in cancer patients. The approval marked an important regulatory milestone that was quickly complemented by the FDA’s acceptance of the Company’s Biologics License Application (BLA) for TX-05, an investigational antineoplastic biologic targeting HER2-positive breast and gastric cancer, a proposed biosimilar to Herceptin^®,² (trastuzumab). Both milestones further validate Tanvex’s expertise in biosimilars and contract biologics development and manufacturing using its U.S. based and FDA licensed manufacturing facility.

John Mosack, Chief Operating Officer of Tanvex commented, “We are incredibly proud of these recent regulatory milestones. They represent a significant step forward for our company, showcasing our dedication to bringing innovative and cost-effective solutions to healthcare via our U.S. based and FDA licensed manufacturing facility. NYPOZI™ will provide an important treatment option for patients, and the acceptance of our TX-05 BLA further demonstrates our continuing commitment to developing and manufacturing high-quality biologics for our clients.”

NYPOZI™ (filgrastim-txid), a biosimilar to Neupogen^®,¹ (filgrastim), was approved for all relevant indications, including chronic administration to reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia.

Neutropenia, a condition characterized by a low count of white blood cells called neutrophils, is a common side effect experienced by cancer patients undergoing chemotherapy treatment. It is estimated that approximately 60,000 to 100,000 cancer patients in the U.S. develop neutropenia each year. Neutropenia can increase the risk of life-threatening infections, as the reduced white blood cell count leaves the body more vulnerable. If left untreated, neutropenia can lead to delays or interruptions in a patient’s cancer treatment, which can negatively impact their overall health outcomes.

By increasing access to effective therapies, the approval of NYPOZI™ has the potential to benefit tens of thousands of individuals in the U.S. who are battling neutropenia as part of their cancer care. “Our deepest gratitude is offered to the patients and their loved ones for participating in our clinical programs and to Tanvex scientists and collaborators for persevering over many years of development,” stated Henry Chen, Chairman and CEO of Tanvex.

About NYPOZI™

SEE FULL PRESCRIBING INFORMATION FOR NYPOZI™ for complete information on indications and usage, dosage and administration, contraindications, warnings and precautions, and adverse reactions.

For subcutaneous or intravenous use, NYPOZI™ is a leukocyte growth factor indicated to:

• Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever
• Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia
• Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT)
• Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis
• Reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia
• Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome)

Nypozi is also approved and available in Canada. SEE PRODUCT MONOGRAPH FOR NYPOZI IN CANADA for information on indications and usage, dosage and administration, contraindications, warnings and precautions, and adverse reactions.

About Tanvex BioPharma USA, Inc.

Tanvex BioPharma USA, Inc., a wholly-owned subsidiary of Tanvex BioPharma, Inc. (TWSE: 6541), was founded in 2011 with a mission to revolutionize the healthcare industry by making biologics more affordable and accessible to patients. Over the years, Tanvex has honed its expertise in biologics development and manufacturing, culminating in the successful commercialization of our first product. With another Biological License Application (BLA) pending U.S. FDA approval, Tanvex’s journey is characterized by an unwavering commitment to excellence, innovation, and a passion for improving patient care.

Tanvex’s dedication to advancing healthcare has led to extending its capabilities, including its technical and operational expertise, to a broader audience as a CDMO – Tanvex CDMO. Biopharma companies leverage Tanvex CDMO’s state-of-the-art, U.S. based and FDA licensed facility, and deep knowledge in biologics development and manufacturing, to bring their products to market efficiently and effectively.

Relevant Links
https://www.tanvex.com
https://tanvexcdmo.com

Media Contact
media@tanvex.com

CDMO Inquiries
cdmosales@tanvex.com

¹Neupogen^® is a registered trademark of Amgen Inc.
²Herceptin^® is a registered trademark of Genentech

Source: Tanvex BioPharma USA, Inc.