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, Jan. 12, 2026 /PRNewswire/ -- 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 South Korea. 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, sales 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. The novel formulation, approved by the US FDA in 2024, 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. In over 600,000 patients annually who receive major ocular procedures for conditions such as cataract, retinal, vitrectomy, and glaucoma, South Korea is estimated to have nearly 800,000 cataract surgeries with anticipated YOY growth.

"We are pleased to expand our relationship with Samil with the mutual goal to serve Korean ocular surgery patients. Samil's rich history and status of being a leader in ophthalmology will ensure that APP13007, poised to be the first ophthalmic steroid introduced since 2008, will reach its full potential." said Erick Co, President and CEO of Formosa Pharmaceuticals.

 "Following the execution of a CMO agreement for APP13007 with Formosa in 2024, this licensing agreement further strengthens the strategic partnership between our two companies. By exclusively commercializing APP13007 in Korea, an innovative therapy whose efficacy and safety have been demonstrated through global clinical trials and U.S. FDA approval, we aim to create mutual value for both parties while providing Korean healthcare professionals and patients with a high-quality treatment option." said Seungbum Huh, Chairman of Samil Pharmaceuticals.

About Formosa Pharmaceuticals, Inc.

Formosa Pharmaceuticals, Inc. (6838.TW) is a clinical stage biotechnology company with primary focus in the areas of ophthalmology and oncology. The company's proprietary 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. For more details about Formosa Pharma and APNT^®, visit www.formosapharma.com.

About Samil Pharmaceuticals Co., Ltd.

Samil Pharmaceutical 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 has established itself as a trusted partner in the global healthcare industry. Expanding into CMO/CDMO services in Ophthalmology field, Samil is seizing global opportunities with a state-of-the-art facility in Ho Chi Minh City, Vietnam, aimed at securing GMP approvals.

For more details about Samil pharm, please visit: https://www.samil-pharm.com/main/EN

SOURCE Formosa Pharmaceuticals Inc.,