'34th Domestic New Drug'... Daewoong Pharmaceutical's 'Pexuprazan' Obtains Domestic Approval

New Drug for Treating Erosive Gastroesophageal Reflux Disease
Achieves Technology Export Worth 1.1 Trillion KRW Before Approval

Daewoong Pharmaceutical Headquarters Exterior (Photo by Daewoong Pharmaceutical)

[Asia Economy Reporter Chunhee Lee] Daewoong Pharmaceutical's 'Pexuprazan' (product name 'Pexuclu Tablet') has been approved as the 34th domestic new drug. Pexuprazan is a new drug for the treatment of gastroesophageal reflux disease that has already achieved technology exports worth over 1 trillion KRW overseas.

Daewoong Pharmaceutical announced on the 30th that its new drug for erosive gastroesophageal reflux disease, Pexuclu Tablet 40mg (active ingredient 'Pexuprazan Hydrochloride'), received product approval from the Ministry of Food and Drug Safety. This is the 34th product approval for a purely domestic new drug. Daewoong Pharmaceutical plans to immediately apply for drug price listing for Pexuclu Tablet and launch the product domestically in the first half of next year.

Pexuclu Tablet is a new drug for gastroesophageal reflux disease developed independently by Daewoong Pharmaceutical. It is a 'P-CAB' formulation that reversibly blocks the proton pump responsible for secreting gastric acid in the stomach lining. It has been clinically proven to inhibit H+/K+ ATPase more rapidly and reversibly than existing PPI-class treatments, thereby suppressing acid secretion and demonstrating rapid symptom improvement and sustained efficacy. From the initial administration, it immediately improved heartburn symptoms regardless of day or night, and especially when administered to patients with severe symptoms, it showed improvement in heartburn symptoms in three times more patients compared to the comparator 'Esomeprazole.'

Seungho Jeon, CEO of Daewoong Pharmaceutical, said, “We expect Pexuclu to alleviate the suffering of many patients suffering from gastroesophageal reflux disease,” and added, “In the new year, our top priority is to officially launch Pexuclu Tablet and grow it into the leading treatment for gastroesophageal reflux disease in Korea.” Pexuclu Tablet has so far achieved technology exports worth approximately 1.1 trillion KRW to the United States, China, the Middle East, and Latin America. Based on this approval, Daewoong Pharmaceutical aims to target the global gastroesophageal reflux disease treatment market worth about 40 trillion KRW.

This content was produced with the assistance of AI translation services.