Sunny' NTN product get TFDA approval
Sunny Pharmtech Inc. (6676), in collaboration with its partner, has achieved key development milestones with regulatory approvals for 2 products, ITN for acne treatment and NTN for idiopathic pulmonary fibrosis, in the Taiwan Market within 6 months.
NTN is indicated for the treatment of idiopathic pulmonary fibrosis (IPF), a chronic, progressive, and irreversible lung disease with significant unmet medical need. As awareness of pulmonary fibrosis continues to grow, the upcoming launch of NTN is expected to support steady revenue contribution to Sunny.
Beyond Taiwan, Sunny Pharmtech and the partner in US, S Company, have successfully submitted an ANDA application of this product to U.S. FDA in September, 2025. The approval is expected to be received in Q3, 2026. The Company is also actively engaging with partners in other regions, with the expectation that the product will gradually expand into multiple markets worldwide. In parallel, Sunny Pharmtech continues to engage with partners in other regions to accomplish the “One product, multiple Registrations” Strategy.
Leveraging its integrated CDMO and development capabilities, Sunny Pharmtech remains committed to strengthening its pipeline and global commercialization strategy, aiming to deliver sustainable long-term value to shareholders.