Business Overview
TAHO Pharmaceuticals Ltd. (6467), founded in 2010, is a specialty pharmaceutical company focused on the development of 505(b)(2) products featuring novel dosage forms, as well as complex generic drugs.
The Company has established a proprietary Transepithelial Delivery System (TDS) platform designed to enhance the delivery of small-molecule drugs across the skin or mucosal membranes into systemic circulation. Leveraging this platform, TAHO is able to develop differentiated drug delivery profiles tailored to clinical needs, ranging from rapid onset to sustained release.
By enabling alternative routes of administration that bypass the gastrointestinal tract and hepatic first-pass metabolism, the TDS platform has the potential to improve bioavailability, reduce certain gastrointestinal or metabolism-related adverse effects, and enhance overall treatment convenience. The technology also addresses unmet needs among patients with swallowing difficulties, while supporting improved medication adherence and patient compliance.
TAHO’s dosage-form development capabilities currently include transdermal patches, orally dissolving films, and buccal films, providing a versatile platform for the development of differentiated pharmaceutical products with enhanced clinical and commercial value.
Product and Corporate Highlights
The Company’s most advanced product candidate, TAH3311, an antithrombotic orally dissolving film (brand name: BEQIA), reached key regulatory milestones during 2025 and 2026. The Company submitted a marketing authorization application to the European Medicines Agency (EMA) in October 2025, followed by a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in June 2026. Both applications have entered substantive regulatory review. On September 4, 2026, the U.S. FDA notified the Company that the PDUFA goal date for completion of its review is April 22, 2027.
TAH3311 is an innovative orally dissolving film formulation of apixaban, an anticoagulant used for the prevention and treatment of thromboembolic conditions, including those associated with atrial fibrillation, deep vein thrombosis (DVT), and pulmonary embolism (PE). According to IQVIA data, U.S. sales of apixaban reached approximately US$29.2 billion in 2025.
In 2025, TAH3311 was granted patents in multiple markets, including the United States, Australia, South Africa, and Taiwan. The differentiated dosage form is designed to address unmet clinical needs, particularly among patients with swallowing difficulties. As the film can be administered without water, it may also help reduce the risk of choking and aspiration pneumonia, alleviate the burden on patients and caregivers, and improve medication adherence. The Company is actively pursuing out-licensing and strategic partnership opportunities to accelerate the product’s commercialization and market launch.
In addition, TAH3341 is a once-daily, extended-release orally dissolving film being developed for the prevention of stroke and thromboembolic events. The program is currently undergoing formulation optimization and is expected to enter clinical development by the end of 2026 or early 2027.
In addition to its novel dosage-form portfolio, TAHO has developed a number of complex generic drug products. TAH4411, an orally dissolving film for the prevention of chemotherapy-induced nausea and vomiting, is the first chemotherapy antiemetic orally dissolving film approved in Japan. The product has received Japanese marketing approval and is currently commercialized by its distribution partner, Miyarisan, with TAHO entitled to licensing income and sales-based revenue sharing.
TAH9922, an oral liquid formulation for the treatment of attention-deficit/hyperactivity disorder (ADHD), has completed a Phase I clinical trial and has been granted a U.S. patent. The U.S. rights to the product have been licensed to Belgium-based pharmaceutical company Hyloris.
TAH9901, a transdermal patch for ADHD, and TAH2211, a sublingual film for the treatment of opioid dependence, have both completed Phase I clinical trials. The Company is actively pursuing licensing and strategic collaboration opportunities for these programs to accelerate subsequent development and expand their commercialization potential.
The development status of the Company’s novel dosage-form drug candidates and complex generic products is summarized below:
Looking ahead, the Company will continue to focus on the research and development of 505(b)(2) drug products featuring novel dosage forms. To strengthen its control over manufacturing capacity and enhance profitability, the Company plans to establish its own production capabilities. Following the completion of clinical development, the Company intends to pursue licensing partnerships with leading global pharmaceutical companies, leveraging their resources, regulatory expertise, and commercial capabilities to accelerate product approvals and market launches.
In parallel, the Company will continue to undertake contract development organization (CDO) projects for multinational pharmaceutical companies, with the objective of building long-term strategic partnerships and expanding opportunities for the development of differentiated and niche pharmaceutical products. Through continued innovation and the development of products that address unmet market needs, TAHO aims to establish itself as a leading developer of TDS-based pharmaceutical products, while driving both the Company and the broader industry toward greater participation in global markets.
