Daewoong's 'Pexuclue' Applies for Phase 1 and 3 Clinical Trials for Helicobacter pylori Treatment in China

Daewoong Pharmaceutical announced on the 22nd that it has simultaneously submitted clinical trial plans for Phase 1 and Phase 3 studies of Pexuclu, a treatment for gastroesophageal reflux disease, for Helicobacter pylori eradication to the National Medical Products Administration (NMPA) of China. The company explained that Phase 2 clinical data conducted in Korea will be used in lieu of a separate trial.

Daewoong Pharmaceutical's gastroesophageal reflux disease treatment 'Pexuclu'
Photo by Daewoong Pharmaceutical

Helicobacter pylori is classified as a Group 1 carcinogen by the World Health Organization (WHO). If not treated promptly, Helicobacter pylori releases ammonia and toxins in the gastric mucosa, gradually damaging the stomach lining. This can lead to indigestion, chronic gastritis, gastric ulcers, duodenal ulcers, and even gastric cancer.

Helicobacter pylori is resistant to stomach acid and can survive in the stomach for a long time, so antibiotics are taken to eliminate it. When Pexuclu is taken together, it suppresses gastric acid secretion, helping acid-sensitive antibiotics effectively eradicate Helicobacter pylori.

According to the local Chinese market research firm iimedia Research, the infection rate of Helicobacter pylori among Chinese people is estimated to be about 50%. Considering the entire population of China, approximately 700 million people are infected. Consequently, the market size for Helicobacter pylori testing in China was 8.66 billion yuan (approximately 1.65 trillion KRW) as of 2022, indicating very high market potential.

Pexuclu is a potassium-competitive acid blocker (P-CAB) for treating gastroesophageal reflux disease, launched by Daewoong Pharmaceutical in July 2022. It improves on the drawbacks of existing proton pump inhibitors (PPIs), such as slow onset of action, short half-life of less than 2 hours, and dietary influences. Notably, Pexuclu has a half-life of 9 hours, the longest among gastroesophageal reflux disease treatments, making it effective in relieving nighttime heartburn symptoms.

Seongsoo Park, CEO of Daewoong Pharmaceutical, said, “China is a market with very high demand for Helicobacter pylori eradication and is also the largest anti-ulcer drug market in the world. We will expand the treatment scope of Pexuclu in China to quickly achieve our ‘one product, one trillion won’ vision.”