Hanmi Pharmaceutical has successfully launched its innovative urological combination therapy Gugutams in Mexico under the local brand name "Aditams," marking a significant expansion of the company's footprint in Latin America. The launch, completed in February 2025, follows an export agreement signed in October 2020 with Mexican pharmaceutical company Laboratorios Silanes.
Gugutams represents a breakthrough in urological medicine as the world's first combination therapy targeting both Obstructive Prostatic Growth (OPG) caused by Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED) simultaneously. The drug combines two active ingredients: tamsulosin, which treats OPG, and tadalafil, which addresses ED.
Innovative Formulation Technology
A notable technological achievement of Gugutams is its use of Poly-Cap technology, making it the first prescription drug in Korea to integrate multiple active ingredients into a single capsule. This innovative approach simplifies dosing regimens for patients who previously needed separate medications for these common urological conditions.
"As the first urological combination therapy to enter the Mexican market, Gugutams is expected to present a new treatment paradigm for local patients," said Park Jae-hyun, CEO of Hanmi Pharmaceutical. "By managing both conditions with a single medication, it significantly enhances patient convenience and maximizes therapeutic efficacy."
Strategic Partnership in Latin America
The launch represents the third Hanmi product to enter the Latin American market through its partnership with Laboratorios Silanes, a leading Mexican pharmaceutical company founded in 1943. The companies previously collaborated to introduce the hypertension and dyslipidemia combination treatment 'Amosartan Q' (local brand 'Lodarta') in 2023 and the combination hypertension treatment 'Amosartan Plus' (local brand 'Bicartial-CTD') in 2024.
Under the current agreement, Hanmi Pharmaceutical will export Gugutams to the Mexican market for seven years, beginning February 2025. Laboratorios Silanes brings significant value to this partnership through its robust distribution network and established presence as a key player in the Latin American pharmaceutical market.
Clinical Significance and Market Impact
BPH affects approximately 50% of men over 50 years of age, with prevalence increasing to 90% by age 80. The condition frequently co-occurs with erectile dysfunction, creating a substantial patient population that could benefit from a combination therapy approach.
Aditams addresses an important clinical need by providing a single treatment option for patients suffering from both conditions. This approach not only improves medication adherence but potentially enhances quality of life for patients by reducing pill burden and simplifying treatment regimens.
Global Expansion Strategy
This Mexican launch aligns with Hanmi's broader strategy to expand its global presence beyond established markets like North America and Japan. The company is actively pursuing partnerships in emerging markets across the Middle East and Latin America.
"Through this collaboration with Laboratorios Silanes, we aim to solidify Hanmi Pharmaceutical's presence in the Latin American market and leverage this as a foundation to further strengthen our competitiveness in the global pharmaceutical industry," added Park.
Hanmi Pharmaceutical, an R&D-focused company, continues to develop innovative therapies in areas of high unmet medical needs, including obesity/metabolism, oncology, and rare diseases. The company leverages proprietary platform technologies such as long-acting biologics and bispecific antibodies while emphasizing open innovation through global partnerships.
