Daewoong Pharmaceutical's 'Pexuclue' Obtains Product Approval in Mexico

Daewoong Pharmaceutical announced on the 18th that its gastroesophageal reflux disease treatment ‘Pexuclu (active ingredient: Pexuprazan Hydrochloride)’ has received product approval from the Mexican Federal Commission for the Protection against Sanitary Risk. This marks the fourth overseas product approval following the Philippines, Ecuador, and Chile. With this approval in Mexico, Pexuclu will be launched under the local product name ‘Abcito (ABCITO)’ in the first half of next year.

Mexico is the largest pharmaceutical market in the Central American region. According to IQVIA, a pharmaceutical market research firm, the size of the anti-ulcer drug market in Mexico was $205 million (approximately 270 billion KRW) as of last year.

Daewoong Pharmaceutical plans to replace the PPI (proton pump inhibitor) market in Mexico with Pexuclu, which improves upon the drawbacks of existing gastroesophageal reflux disease treatments. Currently, PPI formulations account for 90% of prescriptions in the anti-ulcer drug market in Mexico. Furthermore, the company aims to expand export channels for Pexuclu in the Latin American market.

Pexuclu is a new drug for gastroesophageal reflux disease belonging to the P-CAB (potassium-competitive acid blocker) class. It is a next-generation treatment that improves on the limitations of existing PPI drugs, such as slow onset of action, nocturnal acid secretion, dietary influence, and drug interactions.

Daewoong Pharmaceutical plans to continuously promote the strengths of Pexuclu overseas and increase the number of countries submitting product approval applications to 30 by 2025. Currently, Pexuclu has applied for overseas product approval in 12 countries cumulatively, with approvals granted in 4 of them. A Daewoong Pharmaceutical official emphasized, “We will increase the cumulative number of countries applying for product approval to 20 within this year.”

Seungho Jeon, CEO of Daewoong Pharmaceutical, said, “Following product approvals in Ecuador and Chile earlier this year, the news of obtaining product approval in Mexico, the number one market in Central America, shows that the value of Pexuclu continues to be recognized. Furthermore, having successfully completed the inspection by Brazil’s National Health Surveillance Agency (ANVISA) last month, we aim to promptly obtain product approval in Brazil, the largest market in South America, to dominate the Latin American market and achieve our goal of entering 100 countries by 2027.”

This content was produced with the assistance of AI translation services.