Anxo’s Pulmonary Fibrosis P4 Generic Drug Accepted for Review by FDA, Expands into Middle East Market

NTN, a P4 generic drug for pulmonary fibrosis co-developed by Anxo and a domestic partner, has successfully secured a licensing and distribution agreement for the Middle East market. At the same time, the Abbreviated New Drug Application (ANDA) submitted to the U.S. Food and Drug Administration (FDA) has been accepted for review.

NTN is a highly active semi-solid suspension softgel capsule with a high technical barrier to entry. Anxo was responsible for the drug’s formulation design and dosage form development, while its domestic partner handles manufacturing. NTN is primarily used to treat idiopathic pulmonary fibrosis, a chronic, progressive, and irreversible lung disease of unknown cause. As the lungs gradually stiffen and lose elasticity, gas exchange is impaired, leading to symptoms such as shortness of breath, dry cough, and fatigue. If left unaddressed, the disease can progress rapidly, with a mortality rate even higher than that of cancer.

Anxo signed a licensing and distribution agreement for the U.S. market for NTN last year, and has now been notified by its local sales partner that the drug application submitted to the FDA has been accepted for review — the final step before approval. In addition to the U.S. market, Anxo has also submitted a drug application to Taiwan Food and Drug Administration (TFDA), and is continuing discussions with potential partners in Japan and other regional markets to accelerate global regulatory approval.