Anxo Pharmaceutical, a specialist in drug delivery technology, announced on the 30th that its pulmonary fibrosis P4 generic drug, NTN, developed jointly with domestic partners, has not only successfully signed licensing and distribution agreements for the Middle East market, but also received FDA acceptance for review of its Abbreviated New Drug Application (ANDA). Once NTN is launched, Anxo will benefit from sales revenue sharing.

NTN is a high-potency semi-solid suspension soft capsule, representing a high technical threshold. Anxo completed the formulation design and dosage development, while its domestic partner handles manufacturing. Both parties share development costs and will jointly enjoy profits from global sales after market launch.

Anxo highlighted that NTN is primarily indicated for idiopathic pulmonary fibrosis (IPF), a chronic, progressive, and irreversible lung disease. Patients experience stiffening and loss of lung elasticity, impairing oxygen exchange, and presenting symptoms such as shortness of breath, dry cough, and fatigue. The disease can progress rapidly if not closely monitored, with a mortality rate even higher than some cancers. Growing recognition of the severity of pulmonary fibrosis has expanded the market for related therapies; in 2024, the reference patented drug for NTN generated annual sales of $2.76 billion in the U.S. market.

The company added that its collaboration with strategic partners aims to expand global market reach. NTN signed its U.S. market licensing and distribution agreement in 2024, and local partners have confirmed that the FDA has accepted the ANDA submission, marking the final stage before approval. Beyond the U.S., Anxo has submitted a drug registration application to Taiwan’s TFDA and is actively negotiating licensing agreements in Japan and other regions to accelerate global regulatory approvals.

Additionally, Anxo is expediting approvals for other drugs, including anti-epileptics, antipsychotics for schizophrenia, and treatments for benign prostatic hyperplasia with associated urinary disorders. These products have completed bioequivalence (BE) studies, and submissions to TFDA are expected to proceed throughout 2025. Notably, the P4 antipsychotic drug may become Taiwan’s first domestic generic on the market, capturing early commercial opportunities. With new products stacking and overseas expansion underway, the company maintains a positive outlook for future operations.

Resource: 瑩碩肺纖維化P4學名藥插旗中東 ANDA獲FDA受理審查