Daewoong Pharmaceutical said Thursday that its Fexuclue has won regulatory approval as a new drug for gastroesophageal reflux disease (GERD).

The company said the Ministry of Food and Drug Safety authorized 40 milligrams of Fexuclue for erosive GERD. It plans to apply for setting the share of insurance coverage in the drug price of Fexuclue to begin marketing it in the first half of 2022.

Fexuclue is a potassium-competitive acid blocker (P-CAB) that reversibly blocks the proton pump that secretes gastric acid from the stomach wall as a best-in-class new drug for GERD developed by Daewoong.

The new drug has improved symptoms faster and maintained its effects longer than the existing proton pump inhibitors (PPI). It also relieved heartburns from the beginning of the administration and improved the conditions of three times more patients than the esomeprazole group., according to Daewoong.

“Fexuclue will ease the pain of many patients suffering from GERD,” Daewoong Pharmaceutical CEO Jeon Seng-ho said. “Next year, we will launch Fexuclue tablet and develop it into the best GERD treatment in Korea.”

The company has demonstrated the excellence of Fexuclue by signing 1.1 trillion won ($926 million) worth of technology transfer contracts with its partners in the U.S., China, the Middle East, and Central and South America so far.

With the latest approval, Daewoong will try to target the global GERD market worth about 40 trillion won.

Besides, the company is also developing various new pipelines, including enavogliflozin for type 2 diabetes and DWN12088 for pulmonary fibrosis.