Daewoong receives approval for its GERD drug Fexuclue in Ecuador

Daewoong Pharmaceutical said Friday that it has obtained marketing authorization from Ecuador's National Agency for Health Regulation, Control and Surveillance (ARCSA) for its gastroesophageal reflux disease drug Fexuclue (active ingredient: Fexuprazan).

This is the second time after obtaining the first overseas item approval in the Philippines in November last year.

Daewoong Pharmaceutical expects that Ecuador's approval would have a positive effect on approval reviews in neighboring countries in Central and South America, accelerating its entry into the regional market. Currently, it has applied for approval in Mexico, Chile, and Peru in Latin America.

The company has thus far applied for product approval for Fexuclue in a total of 11 countries and disclosed that it would increase the number of applications to more than 20 by the end of this year.

Fexuclue is a potassium-competitive acid blocker (P-Cab) that Daewoong Pharmaceutical launched in South Korea in July last year. It is used for erosive gastroesophageal reflux disease (GERD), acute and chronic gastritis, and improvement in gastric mucosal disease.

"With Fexuclue as a global blockbuster item, we will accelerate our overseas marketing effort with the goal of moving into 100 countries by 2027," said Jeon Seng-ho, CEO of Daewoong Pharmaceutical.

Write to Jung-Eun Kim at likesmile@hankyung.com