Daewoong Pharmaceutical Applies for Marketing Authorization of GERD New Drug 'Pexuclu Tablets' in the Philippines, Indonesia, and Thailand

Pexuclu Tablet Logo.

[Asia Economy Reporter Lee Gwan-joo] Daewoong Pharmaceutical announced on the 28th that it has submitted a New Drug Application (NDA) for Pexuclu tablets (active ingredient: Pexuprazan), a new drug for gastroesophageal reflux disease, to the Philippines, Indonesia, and Thailand, where it operates overseas subsidiaries and branches.

Daewoong Pharmaceutical prepared additional research data required locally and sequentially submitted the NDA to the three countries from last month to mid-this month. This is the first case of applying for product approval in branch countries with a chemically developed new drug since Daewoong Pharmaceutical's overseas business expansion. The approval rights belong to Daewoong Pharmaceutical.

Pexuclu tablets are a best-in-class new drug for gastroesophageal reflux disease independently developed by Daewoong Pharmaceutical. It is a P-CAB (Potassium-Competitive Acid Blocker) formulation that reversibly blocks the proton pump that secretes gastric acid in the stomach lining.

Unlike existing PPI-class treatments, it does not require an activation process, so the drug effect appears quickly from the initial dose, and it has a long half-life, making it highly effective in improving nighttime heartburn symptoms. In particular, clinical trials have proven that the improvement rate of nighttime heartburn symptoms on the third day of administration is higher compared to competing products. It also has the advantage of being taken regardless of meals.

Seung-ho Jeon, CEO of Daewoong Pharmaceutical, said, “Starting with the domestic launch of Pexuclu tablets this year and the submission of approvals in three branch countries, which are key markets in the ASEAN region, we plan to accelerate our full-scale global market entry. Additional overseas approval submissions are scheduled within this year, and development in China and the United States is progressing according to the target schedule. We will nurture Pexuclu tablets as the best product in its class and grow it into a global blockbuster product as soon as possible.”

Pexuclu tablets obtained approval from the Ministry of Food and Drug Safety in Korea last December and aim for domestic launch within the first half of this year.

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