Formosa Pharmaceuticals’ ophthalmic drug AP13007 has officially shipped to the U.S., and further orders are expected by the end of the year. The company has already secured licensing agreements in six countries and regions. The management team, together with strategic partners, aims to capture 10% of the U.S. market share for steroid ophthalmic products and 6-7% of the market across 11 countries globally. This is expected to drive the company’s operations starting from 2025, with profitability projected to break even by 2027.

AP13007 is the first clobetasol propionate product approved by the U.S. FDA for ophthalmic use. In addition to the U.S. market, Formosa Pharmaceuticals has completed licensing agreements in China, Brazil, the Middle East and North Africa (MENA), Israel, and Canada. These partners are leading pharmaceutical companies in the ophthalmic field within their respective markets. Market experts predict that regulatory approvals in MENA and Canada will proceed swiftly, with other regions to follow within the next year.

In parallel, Formosa Pharmaceuticals is also actively developing an HER2-positive breast cancer ADC (antibody-drug conjugate) biosimilar, with plans to launch Phase 1 clinical trials in the EU in 2024. The company is reportedly in discussions with potential partners for licensing, and internal evaluations are underway to select the most suitable partner.

Resource (mandarin): 台新藥AP13007衝刺各國6-10%市佔，營運逐步加溫