[Edaily Reporter YU JIN-HEE ] DongKook Pharmaceutical Co.,Ltd.(086450)is entering the 3000억 won Latin American urology market, led by “Uresco Tablets,” the world’s first improved combination drug for benign prostatic hyperplasia developed in-house.

DongKook Pharmaceutical Co.,Ltd. announced on the 2nd that it has signed a licensing and supply agreement with FAES FARMA, a global pharmaceutical company based in Spain, for “Uresco Tablets” in 13 countries across Central and South America.

Under this agreement, DongKook Pharmaceutical Co.,Ltd. will supply Uresco Tablets worth a total of 39 billion won over the next 10 years to 13 key countries in Central and South America, including Mexico, Colombia, Ecuador, Peru, and Chile. In addition to the confirmed supply agreement, the deal includes a non-refundable upfront payment and milestone payments totaling up to 2 million euros (approximately 3.5 billion won), contingent on local development and sales performance. A long-term profit-sharing structure linked to commercial performance following the product’s launch has also been established.

The partner company, Paes Pharma, is a leading Spanish pharmaceutical firm that operates subsidiaries directly across Europe and Latin America. Having recently designated urology as a strategic therapeutic area for the Latin American market and aggressively expanding its specialty pharmaceutical portfolio, Paes Pharma is considered the ideal partner to drive the successful local launch of Yuresco Tablets.

Paes Pharma plans to formally launch the product after sequentially completing the drug approval process with the health authorities in the countries covered by the agreement. DongKook Pharmaceutical Co.,Ltd. intends to pursue additional agreements with markets such as Brazil—the largest market in Latin America—beyond the regions covered by this agreement, as part of its strategy for mid- to long-term territorial expansion.

Uresco Tablets are the world’s first combination medication to combine 0.5 milligrams (mg) of dutasteride—which reduces prostate size—and 5 mg of tadalafil—which improves symptoms of urinary dysfunction—into a single tablet. Its excellent efficacy and safety have been proven through large-scale clinical trials conducted at 19 general hospitals in South Korea. The combined action of the two ingredients simultaneously induces a dual effect—rapid symptom relief and long-term reduction in prostate size—significantly improving convenience for patients.

The global market for BPH combination drugs is currently estimated at 8300억 won, with the Latin American market accounting for a significant share of approximately 3000억 won. DongKook Pharmaceutical Co.,Ltd. plans to use this license-out as a springboard to secure an exclusive position in the global BPH treatment market.

A DongKook Pharmaceutical Co.,Ltd. official emphasized, “The launch of Uresco Tablets in Latin America marks a significant turning point in showcasing the superior technological capabilities of domestically developed improved combination drugs to the global market,” adding, “We will further accelerate the expansion of our high-value-added pipeline into overseas markets, including the long-acting microsphere injection and liposome-based antifungal agents currently under development based on our drug delivery system (DDS) platform technology.”