Daewoong Pharmaceutical's 'Pexuclu' Applies for Product Approval in Colombia and Vietnam... Approval Completed in 10 Countries

Daewoong Pharmaceutical Fexuclu.
Photo by Daewoong Pharmaceutical

[Asia Economy Reporter Lee Gwan-joo] Daewoong Pharmaceutical announced on the 14th that it recently submitted a New Drug Application (NDA) for the gastroesophageal reflux disease (GERD) new drug 'Pexuclu' (active ingredient: fexuprazan hydrochloride) to Colombia and Vietnam. Accordingly, Daewoong Pharmaceutical has completed NDA submissions in 10 countries globally within one year of Pexuclu's approval in Korea.

According to IQVIA, a pharmaceutical market research firm, based on last year's data, the anti-ulcer drug market in the 10 countries where Daewoong Pharmaceutical submitted NDAs is approximately 2 trillion KRW in scale. The 10 countries where NDA submissions have been completed are Brazil, the Philippines, Indonesia, Thailand, Mexico, Chile, Ecuador, Peru, Colombia, and Vietnam.

Daewoong Pharmaceutical plans to accelerate the global expansion of Pexuclu. First, it aims to apply for product approval in 30 countries worldwide by 2025 and launch the drug in 20 countries. Last month, it obtained the world's first product approval in the Philippines, and next year, it plans to enter China, which has grown into the world's largest market for anti-ulcer drugs.

Pexuclu is the 34th domestic new drug developed by Daewoong Pharmaceutical, launched in Korea in July this year for gastroesophageal reflux disease. It belongs to the potassium-competitive acid blocker (P-CAB) class and improves upon the shortcomings of existing proton pump inhibitors (PPIs) by binding to proton pumps without activation by stomach acid, thereby inhibiting acid secretion quickly and stably. The currently approved indications are ▲erosive gastroesophageal reflux disease treatment (40 mg) and ▲improvement of acute and chronic gastritis gastric mucosal lesions (10 mg).

Daewoong Pharmaceutical is additionally conducting Phase 3 clinical trials to add indications for maintenance therapy after erosive gastroesophageal reflux disease treatment and prevention of ulcers caused by nonsteroidal anti-inflammatory drugs (NSAIDs). Clinical trials for Helicobacter pylori eradication treatment are also planned to begin.

Seungho Jeon, CEO of Daewoong Pharmaceutical, stated, "Pexuclu has demonstrated Daewoong Pharmaceutical's accumulated know-how and global new drug blockbuster development capabilities by completing approval applications in the most countries within a short period after Korean approval among new drugs developed in Korea." He added, "We plan to continuously develop Pexuclu as a global blockbuster through sequential overseas approvals and launches next year."

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