Samil Pharmaceutical and Formosa Sign Exclusive License Agreement for Commercialization of ‘APP13007’ in Vietnam
- January 2026: Expanding Partnership Through Commercialization Agreements in Vietnam Following South Korea
- Expectations for Enhanced Competitiveness in the Global Ophthalmology Market
[Edaily Reporter Kim Ji-wan] #Samil Pharmaceutical announced on the 11th that it has signed an exclusive licensing agreement with Formosa, a Taiwan-based pharmaceutical company, through its Vietnamese subsidiary, securing exclusive distribution and sales rights in the Vietnamese market for “Clobetasol Propionate Eye Drops Suspension 0.05% (APP13007).”
Samil Pharmaceutical’s eye drop CMO plant in Vietnam (Photo: Samil Pharmaceutical)
Founded in 1947, Samil Pharmaceutical is one of Korea’s leading pharmaceutical companies producing products across various therapeutic areas, and it has particularly distinguished itself in the field of ophthalmic treatments.
Samil Pharmaceutical maintains long-standing partnerships with global companies such as Samsung Bioepis, AbbVie, Nicoc, and Théa in the field of ophthalmic therapeutics. This licensing agreement includes an upfront payment, regulatory approval milestones, and royalty payments during the contract period; specific details remain confidential per mutual agreement between the two companies.
“APP13007,” the subject of this agreement, is a patented innovative drug used to treat inflammation and pain following ophthalmic surgery. Its active ingredient is “clobetasol propionate,” a potent corticosteroid, developed using Formosa’s proprietary APNT® nanoparticle formulation platform.
Approved by the U.S. FDA and Health Canada, ‘APP13007’ is characterized by its simple and convenient dosing regimen (twice daily for 14 days), which provides rapid and sustained relief from inflammation and pain.
In a survey of 100 U.S. ophthalmologists, rapid pain relief (approximately 80% reported no pain within four days post-surgery) and a low incidence of side effects (less than 2%) were cited as the primary factors for prescribing ‘APP13007’.
The number of cataract surgeries in Vietnam reaches 300,000 annually, and overall market demand is growing steadily by 5% each year. According to IQVIA’s 2024 sales data, Vietnam’s ophthalmic corticosteroid market generates total annual sales of $4.26 million.
Eric Ko, CEO of Formosa, stated, “We are pleased to collaborate once again with Samil Pharmaceutical to help patients in key regions recover more quickly after ophthalmic surgery.” He added, “I am confident that this collaboration will further strengthen our partnership with Samil and solidify Samil Pharmaceutical’s position as a leading company in the ophthalmology sector.”
Heo Seung-beom, CEO of Samil Pharmaceutical, remarked, “Following the signing of an exclusive domestic distribution and sales agreement for ‘APP13007’ in January 2026, the signing of this exclusive distribution and sales agreement for the Vietnamese market has further strengthened the cooperative relationship between our two companies. We will systematically proceed with approval and launch preparations not only in Korea but also in the Vietnamese market to further enhance our competitiveness in the global ophthalmology market.”
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