Formosa Pharmaceuticals News
Formosa Pharmaceuticals Announces Licensing Agreement with Samil Pharmaceuticals, Co., Ltd, for Commercialization of Clobetasol Propionate Ophthalmic Suspension for the Treatment of Inflammation and Pain Following Ocular Surgery
TAIPEI – June 11, 2026 – Taiwan-based Formosa Pharmaceuticals (“Formosa”, 6838.TW) announced today that the company has entered into an exclusive licensing agreement with Samil Pharmaceuticals, Co., Ltd (“Samil”, 000520.KS), for exclusive rights to the commercialization of clobetasol propionate ophthalmic suspension, 0.05% (APP13007), a patented innovative medicine for the treatment of inflammation and pain following ocular surgery in Vietnam. Samil, established in 1947, is one of the most prominent Korean manufacturers of pharmaceutical products across multiple therapeutic areas, with a core specialization and focus on ophthalmic medicines, and having long-standing partnerships with global players such as Samsung, Abbvie, Nicox, and Thea. The licensing agreement includes upfront payment, regulatory milestones, and royalties, throughout the term of the agreement.
APP13007’s active ingredient is the superpotent corticosteroid, clobetasol propionate, and is derived from Formosa Pharma’s proprietary APNT® nanoparticle formulation platform. Approved by the US FDA and Health Canada, APP13007 enables a convenient and straightforward dosing regimen (twice daily for 14 days) while providing rapid and sustained relief of inflammation and pain. In a US survey of 100 ophthalmic surgeons, rapid resolution of pain (~80% pain-free four days post-surgery) and low incidence of adverse events (<2%) were highlighted as key drivers to prescribing APP13007. The number of cataract surgeries in Vietnam is reaching 300,000 annually, with overall market demand experiencing a steady 5% annual growth. According to 2024 IQVIA sales data, the ophthalmic corticosteroid market in Vietnam generated a total annual sales value of $4.26 million USD.
“We are pleased to join efforts yet again with Samil with the mutual goal to serve its key regions, enabling patients to recover more quickly from ocular surgery. We are confident this step further strengthens our commitment and relationship with Samil and its status of being a leader in ophthalmology.” said Erick Co, President and CEO of Formosa Pharmaceuticals.
“Following our exclusive license agreement signed in January 2026 for the commercialization of APP13007 in South Korea, this new agreement for the Vietnam market further strengthens our partnership with Formosa Pharmaceuticals. We will move forward steadily with the regulatory approval and launch preparations in both the Korean and Vietnamese markets, further enhancing our competitiveness in the global ophthalmology business,” said Seung-Bum Huh, CEO of Samil Pharmaceuticals Co., Ltd.
About Formosa Pharmaceuticals, Inc.
Formosa Pharmaceuticals, Inc. (6838.TW) is a clinical stage biotechnology company featuring its “Double A” strategy, covering Antibody-drug conjugates (ADC) and its proprietary APNT® nanoparticle formulation technology. APNT®, through which APP13007 was developed, improves the dissolution and bioavailability of APIs for topical, oral, and inhaler administration. Resulting formulations have high uniformity, purity, and stability, thereby allowing the utilization of poorly soluble or extremely potent drug agents which otherwise may face insurmountable challenges in delivery and penetration to target tissues. ADCs include TSY-110, a biosimilar of breast cancer therapy, Kadcyla®, and TSY-310, a novel bispecific ADC targeting EGFR and ROR1 for solid tumors such as NSCLC. For more details about Formosa Pharma and its Double A strategy, visit www.formosapharma.com.
About Samil Pharmaceuticals Co., Ltd.
Samil Pharmaceuticals Co., Ltd. (000520.KS), founded in 1947 and headquartered in Seoul, South Korea, is a pharmaceutical company with core expertise in ophthalmology, hepatology, gastroenterology, and CNS disorders. As part of its global expansion strategy, Samil operates overseas subsidiaries in North America, Vietnam, and Japan. Through ongoing partnerships with more than 10 global pharmaceutical companies, Samil Pharmaceuticals Co., Ltd. is expanding its business into CMO/CDMO services in the ophthalmology sector and has built a state-of-the-art facility in Ho Chi Minh City, Vietnam, which has already obtained WHO GMP certification. The company is actively pursuing additional global certifications, including KGMP, cGMP, and EUGMP, as part of its strategy to expand into the global market. For more details about Samil Pharmaceuticals Co., Ltd., please visit: https://www.samil-pharm.com/main/EN
Formosa Pharmaceuticals Contact:
Wayne Wei, MPH, CLP, RAC
Chief Strategy & Business Officer