Daewoong's 'Pexuclu' Targets World's Largest Market... Applies for Product Approval in China

Daewoong Pharmaceutical announced on the 27th that it has submitted the marketing authorization application for ‘Pexuclu 40mg (active ingredient: fexuprazan hydrochloride),’ a potassium-competitive acid blocker (P-CAB) class gastroesophageal reflux disease treatment developed in-house, to the Center for Drug Evaluation under the National Medical Products Administration (NMPA) of China.

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

With this approval application, Pexuclu takes its first step toward entering China, the world's largest anti-ulcer drug market. According to IQVIA, a pharmaceutical market research firm, the size of the anti-ulcer drug market in China reached approximately 3.3 trillion KRW last year.

Daewoong Pharmaceutical explained that the efficacy and safety of Pexuclu were confirmed in a Phase 3 clinical trial conducted on 332 patients with erosive gastroesophageal reflux disease in China. Having successfully achieved all targeted clinical endpoints, including rapid onset of action, mucosal healing effects, and improvement in heartburn, cough, and acid reflux, the approval process for Pexuclu is expected to proceed smoothly.

Professor Y. Xiao of Sun Yat-sen University, the principal investigator of the Chinese Phase 3 clinical trial, stated, “Unlike proton pump inhibitors (PPIs), which take a long time to show efficacy, P-CABs have the advantage of demonstrating drug effects within just one day and showing consistent efficacy regardless of pre- or post-meal administration. Pexuclu is expected to lead this trend as P-CABs gradually replace PPIs.”

P-CAB drugs like Pexuclu are next-generation treatments for gastroesophageal reflux disease that improve upon the drawbacks of existing PPI drugs, such as slow onset of action, dietary influences, and drug interactions. Pexuclu binds to proton pumps without activation by gastric acid, providing rapid acid secretion inhibition. Notably, it stably suppresses gastric acid regardless of meal timing and has the longest half-life of 9 hours among gastroesophageal reflux disease treatments.

Thanks to these efficacies, since its domestic launch in July last year, Pexuclu has shown a monthly growth rate of 15%, surpassing a cumulative prescription amount of 30 billion KRW within 11 months. Additionally, negotiations are underway with multiple multinational pharmaceutical companies to simultaneously conduct clinical development in major global markets including North America, Europe, and Japan.

Seungho Jeon, CEO of Daewoong Pharmaceutical, said, “The swift submission of the marketing authorization application for Pexuclu in China, the world’s largest market in the anti-ulcer drug field, reflects the successful implementation of Daewoong Pharmaceutical’s unique acceleration strategy. We plan to expand the number of countries submitting overseas marketing authorization applications to 30 by 2025 and aim to enter 100 countries by 2027, nurturing Pexuclu into a truly global blockbuster new drug.”

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