Tanvex BioPharma USA Enters License and Supply Agreement with Invagen Pharmaceuticals, a Cipla Group Company, for the Commercialization of NYPOZI in the United States

Tanvex BioPharma, Inc. (“Tanvex”), a subsidiary of Tanvex BioPharma, Inc. and a contract development and manufacturing organization (CDMO) specializing in biologics under the brand Bora Biologics (“Bora Biologics”), is excited to announce a strategic license and supply agreement with Invagen Pharmaceuticals, Inc., a wholly owned subsidiary of Cipla Limited in United States (hereinafter referred as “Cipla“). This partnership will facilitate the commercialization of NYPOZI™ (filgrastim-txid), a biosimilar to Neupogen®, in the United States.

Under the terms of this agreement, Cipla will be responsible for the marketing and sales of NYPOZI™ to healthcare providers and patients throughout the U.S. market. Tanvex BioPharma will benefit from milestone payments, supply payments, and a share of the profits generated from Invagen’s sales of NYPOZI™. The collaboration underscores Tanvex’s commitment to expanding access to high-quality biosimilars and reinforces its position in the competitive biologics landscape.

“We are thrilled to partner with Cipla to bring NYPOZI™ to the U.S. market,” said Stephen Lam, CEO of Tanvex. “This agreement not only validates the value of our development capabilities, but also allows us to focus our efforts and resources on scaling our CDMO platform to meet the rising global demand for high-quality biologics manufacturing while unlocking the value of our biosimilar assets.”

The agreement reflects Tanvex’s dedication to collaboration and innovation in the biopharmaceutical sector. While specific financial details remain confidential, the partnership represents a significant step forward in delivering life-saving therapies to patients across the United States. The companies are actively working on launch plans and expect to introduce NYPOZI™ in the United States in the coming months.

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.