Daewoong Pharmaceutical Indonesia

Daewoong’s Innovative P-CAB New Drug Fexuprazan Approved in Indonesia

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April 17, 2026

- Next-generation P-CAB mechanism provides fast and powerful acid suppression for the treatment of erosive esophagitis.

- Accelerating entry into Indonesia; presenting tailored treatment solutions through collaboration with local medical professionals.

- World-class efficiency of WLA-listed BPOM results in rapid approval.

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Jakarta – April 17, 2026

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Daewoong Pharmaceutical Indonesia (hereinafter Daewoong) announced that it has officially secured product approval from the Indonesian Food and Drug Authority (BPOM) for ‘Fexuprazan 40mg’, its self-developed innovative new drug for the treatment of erosive esophagitis (EE).

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Self-Developed Innovative New Drug for the Treatment of Erosive Esophagitis through P-CAB Mechanism

Current first-line treatments for gastroesophageal reflux disease (GERD) in Indonesia, namely proton pump inhibitors (PPIs), have been consistently associated with several mechanistic limitations. These include a delayed onset of action requiring several days to reach maximum effect, low dosing convenience due to the need for pre-meal administration, variability in therapeutic response, and inherent structural limitations such as a short half-life, which makes it difficult to adequately control nocturnal acid secretion.

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Fexuprazan, which has now secured approval in Indonesia, is a self-developed innovative new drug created through Daewoong’s proprietary research and development capabilities. As a P-CAB (Potassium-Competitive Acid Blocker), Fexuprazan binds directly to proton pumps without requiring acid activation, demonstrating rapid effects from the very first dose and showing improvement in both daytime and nighttime heartburn.

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Notably, the drug is designed to have low dependence on the liver metabolic enzyme CYP2C19 during the metabolic process, thereby reducing the burden of drug-drug interactions and minimizing efficacy variations between patients. Furthermore, the convenience of once-daily dosing regardless of mealtime is expected to enhance the quality of life for local patients suffering from erosive esophagitis.

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Strengthening Clinical Evidence and Pursuing Multi-Country Collaboration for Indication Expansion

Moving beyond simple product supply, Daewoong intends to establish a precision treatment environment in the field of digestive disease treatment by strengthening close clinical and academic cooperation with local Indonesian medical professionals. Daewoong plans to submit a Multi-country Phase 3 Clinical Trial Application (IND) to the Indonesian Food and Drug Authority (BPOM) for the purpose of expanding the indications of Fexuprazan in South Korea and Indonesia. By securing real-world clinical data that reflects the specific characteristics of Indonesian patients, Daewoong aims to build a scientific foundation optimized for the local medical environment and focus its capabilities on strengthening the clinical trust of local healthcare providers

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Baik In Hyun, Executive Director of Indonesia Business Division at Daewoong, stated, “This Indonesian approval is highly significant as it allows us to provide patients with a new treatment solution.” He expressed his deep appreciation for BPOM’s dedication to expanding access to innovative medicines, adding, “The efficient review process by BPOM reflects the authority’s strong commitment to strengthening the national pharmaceutical sector and improving patient outcomes.” He further emphasized, “During the review process, we confirmed that BPOM possesses high-level regulatory capabilities as a WLA (WHO Listed Authority), and we directly felt their immense efforts for national public health.” He concluded, “We will continue to expand clinical research and academic exchanges based on collaboration with Indonesian medical professionals to become a true healthcare partner contributing to the health of Indonesian citizens.”

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Indonesia: Southeast Asia's Largest Market, a Strategic Hub for Global Expansion

Indonesia is the world’s fourth most populous country with approximately 280 million people and represents the largest anti-ulcer market in Southeast Asia. According to data from the global market research firm IQVIA, the local market size reached approximately IDR 2.4 trillion (approx. USD 154.96 million) as of 2024. The market continues to show a steady annual growth rate of about 6% due to the Westernization of dietary habits and a subsequent surge in patients with gastric disorders. Daewoong plans to provide innovative treatment options to Indonesian patients and become a key partner leading the mutual growth of Southeast Asia's digestive disease treatment market.

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Currently, Fexuprazan has entered 30 countries worldwide through export contracts, of which 16 countries—including China and Indonesia—have granted product approvals, further accelerating its global market presence.

list

- Next-generation P-CAB mechanism provides fast and powerful acid suppression for the treatment of erosive esophagitis.

- Accelerating entry into Indonesia; presenting tailored treatment solutions through collaboration with local medical professionals.

- World-class efficiency of WLA-listed BPOM results in rapid approval.

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