Daewoong Pharmaceutical's GERD New Drug 'Pexuclu' Obtains Marketing Authorization in Chile

Approval Granted in Chile, the 4th Largest Market in Latin America

Daewoong Pharmaceutical announced on the 14th that its gastroesophageal reflux disease treatment 'Pexuclu' (active ingredient: fexuprazan hydrochloride) obtained product approval from the National Institute of Medicines (ANAMED) under the Chilean Public Health Institute (ISP) on the 20th of last month.

Daewoong Pharmaceutical Pexuclu. [Image provided by Daewoong Pharmaceutical]

With this approval, Daewoong Pharmaceutical has secured product approvals in Latin America for two consecutive months, following Ecuador in January. Chile, being the fourth largest market in Latin America and a reference country for approvals in major South American countries such as Argentina, is expected to accelerate Daewoong Pharmaceutical's expansion into the Latin American market, according to the company.

Pexuclu is a potassium-competitive acid blocker (P-CAB) drug for gastroesophageal reflux disease that Daewoong Pharmaceutical launched domestically in July last year. It improves on the shortcomings of existing proton pump inhibitors (PPIs) by binding to proton pumps without activation by gastric acid, thereby inhibiting acid secretion quickly and stably. Its indications include ▲erosive gastroesophageal reflux disease treatment ▲improvement of acute and chronic gastritis gastric mucosal lesions. Notably, Pexuclu is the only P-CAB drug approved for gastritis indications in South Korea.

Starting with the Philippines in November last year, Daewoong Pharmaceutical has obtained product approval for Pexuclu in three countries to date. The company plans to increase the number of countries where it submits product approval applications to more than 20 by the end of this year. Currently, Daewoong Pharmaceutical has completed NDA submissions in a total of 11 countries and plans to submit for product approval in China, which has grown into the largest market this year.

Jeon Seung-ho, CEO of Daewoong Pharmaceutical, stated, "Daewoong Pharmaceutical, which achieved the first approval of a domestic new drug in Chile, will take the lead in pioneering overseas markets and actively fulfill its role for the development of the domestic pharmaceutical industry." He added, "We will continue to develop Pexuclu into a global blockbuster product and accelerate overseas expansion with the goal of entering 100 countries by 2027."