Tanvex BioPharma's Dual Victory, Two U.S. Regulatory Approvals

Tanvex BioPharma USA, Inc., a leading CDMO specializing in biologics and biosimilars, has achieved significant progress with two major regulatory milestones. The U.S. FDA recently granted approval for NYPOZI™ (filgrastim-txid), a biosimilar to Neupogen®, designed to treat chemotherapy-induced neutropenia in cancer patients.

Additionally, the FDA has accepted Tanvex's Biologics License Application (BLA) for TX-05, an investigational biosimilar to Herceptin® (trastuzumab), aimed at treating HER2-positive breast and gastric cancers. These developments underscore Tanvex's growing reputation in biosimilar innovation and manufacturing, backed by its FDA-licensed U.S. facility.

John Mosack, Chief Operating Officer of Tanvex said, “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 of Neupogen® (filgrastim), has received approval for all pertinent uses, including long-term administration to lower the risk and severity of complications such as fever, infections, and mouth ulcers in patients suffering from congenital, cyclic, or idiopathic neutropenia.

Neutropenia, marked by a deficiency of neutrophils—a type of white blood cell—is a frequent and serious side effect of chemotherapy in cancer patients. Each year in the U.S., an estimated 60,000 to 100,000 cancer patients experience this condition. Neutropenia significantly heightens the risk of severe infections due to the weakened immune system, and if untreated, can lead to treatment delays or interruptions, ultimately compromising the patient's health and recovery.

The approval of NYPOZI™ could significantly impact the lives of tens of thousands of U.S. cancer patients by providing greater access to effective therapies for neutropenia. Henry Chen, Chairman and CEO of Tanvex, commented,  “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.