Formosa Pharmaceuticals, Inc. (“Formosa Pharma”) was established in 2010. It is a biotechnology company focused on developing drugs for ophthalmology, oncology, and other therapeutic areas in the clinical stage. The company possesses a widely applicable and fully patented APNT nanotechnology platform and new drug assets.
Proprietary, patented technology with strong patent deployment
The APNT® nanoparticle platform uses salts and sugars as grinding media to reduce drug particle size with high uniformity. APNT® nanoparticles have the advantages of stability, low precipitation, and enhanced permeability in poorly soluble drugs, improving dissolution performance, bioavailability, and formulation stability, thus aiding in successful drug formulation development. This technology can be applied to eye drops, inhalation preparations, skin medications, and oral drugs with poorly water-soluble main ingredients.
The APP13007 ophthalmic nanosuspension, derived from APNT® technology, utilizes the superpotent steroid Clobetasol Propionate, originally used only for skin diseases in past decades; APP13007 is the first new drug to use this API for the eye and first to successfully obtain FDA approval in the US. Furthermore, this is the first new ophthalmic corticosteroid approved in the US in more than 15 years, and validates the APNT® technology's drug-forming capability. More new drug formulations utilizing this platform's advantages are expected to be developed. To date, 123 patents related to the APNT® nanoparticle platform and APP13007 nano-suspension eye drops have been obtained globally, covering major drug development countries and key pharmaceutical markets worldwide.
Precision in candidate selection with pharmaceutical development insights
APP13007 nano-suspension eye drops obtained FDA approval in March 2024. Phase III clinical trial in China were initiated in Q4 2023. With its convenient usage, stable and homogeneous formulation, and proven safety profile, and low incidence of adverse reactions like eye pain and foreign body sensation, APP13007 has attracted significant attention from major ophthalmic pharmaceutical companies worldwide. Formosa Pharma has successfully licensed APP13007 in markets including the US, China, Middle East and North Africa (MENA), Brazil, Israel and Canada. The drug may expand its indications to include dry eye syndrome, uveitis, and allergic conjunctivitis, contributing to growth momentum.
Formosa Pharma is also focused on developing ADC biosimilars for breast cancer treatment. TSY-0110, an ADC biosimilar of Roche’s Kadcyla® (ado-trastuzumab emtansine), targets metastatic and early breast cancer. Given the high development threshold for biosimilars, Formosa Pharma is co-developing this drug with EirGenix, using high-quality antibodies as raw materials and combining Formosa Laboratories’ bioconjugation technology and production capabilities for high-potency drugs. TSY-0110 is currently about to enter phase I clinical trials.
Future Outlook
Formosa Pharma will continue to utilize APNT® nanoparticle platform, through independent development or collaboration with other biotech and pharmaceutical companies, to develop high-demand, high-revenue potential drugs. The company aims to expand and enrich its existing pipeline and platform technology. By collaborating with global strategic partners, Formosa Pharma seeks to mitigate the risks of developing innovative drugs. The company will persist in its efforts, steadily growing to become a benchmark enterprise in new drug development and international licensing in Taiwan.
