Formosa Pharmaceuticals, Inc. (TPE: 6838) has entered an exclusive licensing agreement with Samil Pharmaceuticals Co., Ltd. (000520.KS), granting the South Korea-based company commercialization rights to APP13007 (clobetasol propionate ophthalmic suspension, 0.05%) for the South Korean market. The patented post‑ocular surgery anti‑inflammatory therapy expands Formosa’s Asia‑Pacific footprint through a local partner with established ophthalmology infrastructure.
Transaction Overview
Element
Detail
Licensor
Formosa Pharmaceuticals, Inc. (TPE: 6838, Taiwan)
Licensee
Samil Pharmaceuticals Co., Ltd. (000520.KS, South Korea)
High anti‑inflammatory efficacy vs. standard post‑op drops
Formulation
Ophthalmic suspension, 0.05%
Optimized ocular penetration and retention
Indication
Post‑ocular surgery inflammation and pain
Addresses high‑volume cataract and refractive surgery markets
Innovation Status
Patented formulation
Differentiation from generic prednisolone or dexamethasone drops
Target Market & Strategic Rationale
Factor
Market Context
South Korea Ophthalmology Market
>200,000 cataract surgeries annually; growing refractive surgery (LASIK/SMILE) volume; established reimbursement for post‑op anti‑inflammatories
Samil Positioning
Leading Korean ophthalmology pharma company with existing hospital and clinic relationships; dedicated eye care sales force
Formosa Regional Strategy
Taiwan‑to‑Asia expansion leveraging local partners for regulatory, reimbursement, and commercial execution vs. de novo infrastructure
Corticosteroid Competition
Prednisolone acetate (generic) and Lotemax (bromfenac) dominate; APP13007’s potency and patent protection enables premium positioning
Development & Commercial Outlook
Phase
Activity
Timeline
Current
Licensing agreement execution; technology transfer initiation
Q1 2026
Regulatory
South Korea MFDS (Ministry of Food and Drug Safety) submission
2026
Approval
MFDS marketing authorization
2026‑2027
Launch
Samil commercial rollout to ophthalmology clinics and hospitals
2027
Performance
Sales milestones and royalty payments to Formosa
Ongoing
Forward‑Looking Statements This brief contains forward‑looking statements regarding APP13007 regulatory approval timelines in South Korea, Samil Pharmaceuticals’ commercial execution, and Formosa Pharmaceuticals’ Asia‑Pacific expansion strategy. Actual results may differ due to MFDS review delays, competitive pricing pressure from generic corticosteroids, and ophthalmology market access dynamics in South Korea.-Fineline Info & Tech
By Fineline Cube