Daewoong Pharmaceutical said it has submitted a new drug application (NDA) for Fexuprazan, its gastroesophageal reflux treatment, to four Latin American countries -- Mexico, Chile, Ecuador, and Peru.

Fexuprazan is undergoing a product approval process in eight countries, the company said.

Daewoong said it aims to release Fexuprazan to the Korean market this year, minimizing the gap between the launch times in major overseas countries.

The company also expects to lift its status as an original new drug product in each country by securing the duration of the substance patent for as long as possible compared to competing drugs.

“Since the company received approval for Fexuprazan in Korea in December, it has tried to enter the global market by quickly completing additional approval submissions to three ASEAN countries and five Latin American countries,” Daewoong Pharmaceutical CEO Jeon Seung-ho said.

Making Fexuprazan a global blockbuster drug is sailing smoothly as additional overseas product approvals, and clinical trials in China are going on as planned, Lee added.

Fexprazan is a new P-CAB (potassium-competitive acid blocker) drug treating gastroesophageal reflux by reversibly blocking proton pumps that secrete stomach acids from the stomach wall, according to Daewoong.

In addition to the strong gastric acid secretion inhibitory effect, the drug does not require an activation process, unlike existing PPI-based therapeutics, demonstrating the advantages of rapid drug expression and long drug action time.

The drug also shows a superior effect in improving symptoms of heartburn and pain at night compared to competing products through clinical trials, and patients can take the drug regardless of meals, the company said.