Daewoong Applies for Approval in Saudi Arabia to Enter Middle East Market with 'Pexuclu'...

Daewoong Pharmaceutical's new drug for gastroesophageal reflux disease, 'Pexuclu'
[Photo by Daewoong Pharmaceutical]

[Asia Economy Reporter Chunhee Lee] Daewoong Pharmaceutical's new drug for gastroesophageal reflux disease, Pexuclu (active ingredient: fexuprazan hydrochloride), is set to enter the Middle East market.

Daewoong Pharmaceutical announced on the 26th that it recently submitted a New Drug Application (NDA) for Pexuclu, a potassium-competitive acid blocker (P-CAB) class drug, to the Saudi Food and Drug Authority (SFDA). This marks the 11th overseas approval application for Pexuclu.

According to IQVIA, a pharmaceutical market research firm, the anti-ulcer drug market in Saudi Arabia was worth 410 billion KRW as of 2021, ranking 12th globally and the largest market among Middle Eastern countries. Daewoong Pharmaceutical plans to use this Saudi Arabia approval application as a stepping stone to expand not only in Saudi Arabia but also in the Gulf Cooperation Council (GCC) countries. The GCC is an international organization consisting of six Arabian Peninsula countries: Saudi Arabia, Bahrain, the United Arab Emirates (UAE), Oman, Qatar, and Kuwait.

Previously, in October 2021, Daewoong Pharmaceutical signed a contract with Aghrass Healthcare Limited, a subsidiary of the Cigalah Group, to supply Pexuclu to the six GCC countries for the next 10 years. The projected sales volume estimated by both companies amounts to 82.97 million USD (approximately 102.4 billion KRW).

Daewoong Pharmaceutical plans to apply for product approval in 30 countries worldwide by 2025 and launch the drug in 20 countries. Notably, this year, it intends to submit a product approval application for China, which has grown into the world's largest anti-ulcer drug market with a market size of about 4.2 trillion KRW, surpassing the United States.

Pexuclu is a new drug for gastroesophageal reflux disease that Daewoong Pharmaceutical launched domestically in July last year. As a P-CAB agent, it improves upon the shortcomings of existing proton pump inhibitors (PPIs) by binding to the proton pump without activation by stomach acid, thereby inhibiting acid secretion quickly and stably. Currently, it has secured two indications: treatment of erosive gastroesophageal reflux disease and improvement of gastric mucosal lesions in acute and chronic gastritis. According to UbiStat, a pharmaceutical sample statistics information source, Pexuclu's prescription amount last month was 2.9 billion KRW, showing rapid growth since its launch.

Seungho Jeon, CEO of Daewoong Pharmaceutical, stated, “By submitting the approval application in Saudi Arabia, which has the largest anti-ulcer drug market among Middle Eastern countries, we have accelerated our entry into the Middle East following Asia and Latin America. This year, through approval submissions and sequential launches in 10 countries, we will continue to develop Pexuclu into a global blockbuster beyond the domestic market.”