Daewoong Pharmaceutical Accelerates Latin America Expansion of 'Pexuclu Tablets'... Approval Applications Submitted for Mexico and 3 Other Countries

Daewoong Pharmaceutical's gastroesophageal reflux disease 'Pexuclu' logo

[Asia Economy Reporter Chunhee Lee] Daewoong Pharmaceutical's new drug for gastroesophageal reflux disease, Pexuclu Tablet (active ingredient 'Pexuprazan Hydrochloride'), is accelerating its entry into the Latin American market.

Daewoong Pharmaceutical announced on the 23rd that it submitted new drug application (NDA) dossiers for Pexuclu Tablet to Mexico, Chile, Ecuador, and Peru in the second quarter of this year.

With this, following the domestic approval at the end of last year, the company is simultaneously pursuing product approvals in a total of eight countries, including Brazil, the Philippines, Indonesia, and Thailand, where applications were previously submitted.

In particular, the Latin American pharmaceutical market is gaining attention as a global "Pharmerging Market" (pharmaceutical and bio emerging market) based on steady annual growth. According to global IMS data, as of last year, the pharmaceutical market size by country in Latin America is estimated at ▲Brazil $22.8 billion (approximately 29 trillion KRW) ▲Mexico $8.5 billion (approximately 10.784 trillion KRW) ▲Chile $2.0 billion (approximately 2.537 trillion KRW) ▲Ecuador $1.7 billion (approximately 2.156 trillion KRW) ▲Peru $1.0 billion (approximately 1.268 trillion KRW).

Daewoong Pharmaceutical plans to launch Pexuclu Tablet in the domestic market within this year while minimizing the time gap for release in major overseas countries. Additionally, by securing the longest possible patent protection period for the compound in each country compared to competing drugs, the company expects to maximize the status of Pexuclu Tablet as an original new drug product in each market.

Pexuclu Tablet is a new drug for gastroesophageal reflux disease developed by Daewoong Pharmaceutical targeting the best-in-class within its category. It is a "Potassium-Competitive Acid Blocker (P-CAB)" that reversibly inhibits the proton pump responsible for secreting gastric acid in the stomach lining. It received domestic approval from the Ministry of Food and Drug Safety in December last year.

In addition to its strong gastric acid suppression effect, unlike existing proton pump inhibitor (PPI) treatments, it does not require an activation process, resulting in rapid onset of action and a long duration of effect.

Seungho Jeon, CEO of Daewoong Pharmaceutical, said, “Since the domestic approval in December last year, Pexuclu Tablet has quickly completed additional approval submissions in three ASEAN countries and five Latin American countries, steadily advancing into the global market. Additional overseas product approvals and clinical trials in China are proceeding as scheduled, so we expect smooth progress in developing Pexuclu Tablet into a global blockbuster.”