Daewoong Pharma's GER drug gets product OK from Mexico

South Korea’s Daewoong Pharmaceutical on Wednesday said its gastroesophageal reflux (GER) disease drug Fexuclue (active ingredient fexuprazan hydrochloride) has received product approval from Mexico’s COFEPRIS, or the Federal Committee for Protection from Sanitary Risks.

Mexico is the fourth country excluding South Korea to authorize Fexuclue, which was released in its nation of origin two years ago.

Mexico has the largest pharmaceutical market in Central and South America, with its ulcer drug sector alone worth $205 million (270 billion won) last year according to the US-based pharmaceutical market observer IQVIA.

As a new drug for GER disease in the potassium-competitive acid blocker (P-CAB) class, Fexuclue improves the shortcomings of other proton pump inhibitors like time needed to take effect, acid secretion at night and dietary influences.

By 2025, Daewoong Pharmaceutical seeks to secure approval for Fexaclue from 30 countries. So far, it has received the OK from four of the 12 countries it has applied with and plans to raise that number to a cumulative 20 within the year.

"The news of our product approval from Mexico, the No. 1 market in Central and South America, following those received early this year from Ecuador and Chile, shows how Fexuclue’s value continues to gain recognition," Daewoong Pharmaceutical CEO Jeon Seng-ho said.

Write to In-Hyuk Park at hyuk@hankyung.com