Daewoong Pharmaceutical's 'Fexuprazan' Expands into Latin America: Enters $300 Million Market in Mexico, Chile, and Ecuador

Daewoong Pharmaceutical's 'Fexuprazan' Expands into Latin America: Enters $300 Million Market in Mexico, Chile, and Ecuador Seoul, S. Korea, August 8th, 2024 Daewoong Pharmaceutical’s novel treatment for gastroesophageal reflux disease (GERD), 'Fexuprazan,' is making significant inroads into the Latin American market. Daewoong Pharmaceutical (Co-CEOs Seongsoo Park and Chang-jae Lee) announced the official launch of Fexuprazan in Mexico, Chile, and Ecuador. According to IQVIA, a leading pharmaceutical market research firm, the anti-ulcer drug market in these three countries was valued at $300 million (approximately KRW 415.5 billion) last year. Developed using Daewoong's proprietary technology over 13 years, Fexuprazan was first launched in Korea in July 2022. As a P-CAB (Potassium-Competitive Acid Blocker), Fexuprazan offers rapid and stable acid suppression, addressing the slow onset and dietary restrictions associated with traditional PPI (Proton Pump Inhibitor) treatments. With a long half-life of 9 hours, Fexuprazan is particularly effective for nighttime acid reflux and can be taken without regard to meals, offering great convenience to patients. With the recent launches in Mexico, Chile, and Ecuador, Fexuprazan is now available in five countries, including Korea and the Philippines. During the launches, symposiums were held in these countries, where local medical experts expressed strong support for Fexuprazan as a superior alternative to existing PPI treatments, highlighting its proven efficacy. On July 20 in Mexico, the launch of Fexuprazan was met with enthusiasm. Dr. Miguel Angel Valdovinos Diaz, a gastroenterology professor at the National Autonomous University of Mexico, highlighted the unmet needs in GERD treatment caused by the instability and dietary influences of PPIs. He suggested Fexuprazan as a promising solution. Support for Fexuprazan continued with insights from Dr. Michael F. Vaezi, a gastroenterology professor at Vanderbilt University Medical Center in the U.S., who emphasized the necessity of P-CAB treatments like Fexuprazan for various reflux diseases and functional gastrointestinal disorders that PPIs fail to address. Professor Kim Do-hoon from Asan Medical Center in Seoul shared recent clinical findings on Fexuprazan at the symposium in Mexico, detailing how this next-generation P-CAB drug effectively resolves the slow onset and incomplete acid suppression issues of PPIs while minimizing drug interactions. Professor Kim further highlighted two foundational studies demonstrating additional anti-inflammatory benefits of Fexuprazan (inhibiting the pyroptosis pathway in esophageal cells and reducing inflammatory cytokines due to NSAID-induced enteritis its anti-inflammatory properties against Helicobacter pylori-induced gastric epithelial cell damage). These studies, presented at the '2024 Digestive Disease Week' in the U.S. in May, attracted significant attention. At a symposium on July 17 in  Chile, Dr. Arnoldo Riquelme, a renowned gastroenterologist and professor at the Pontifical Catholic University of Chile, introduced Fexuprazan, stressing its potential to overcome the drawbacks of PPIs. During a symposium in Ecuador on June 28, Dr. Santiago Dávila, a gastroenterologist at Universidad San Francisco de Quito, emphasized the need for new GERD treatments. He noted that many patients are not adequately managed with current PPIs due to their pharmacological limitations. CEO Seongsoo Park of Daewoong Pharmaceutical expressed his satisfaction with Fexuprazan's recognition as a next-generation GERD treatment among Latin American medical professionals. "We are committed to accelerating the approval process to introduce Fexuprazan rapidly across Latin America and aim to achieve our goal of entering 100 countries by 2027," he stated. As of July 2024, Fexuprazan has entered or is about to enter the markets in 30 countries, including Korea, the Philippines, Mexico, Chile, and Ecuador. Market applications have been submitted in 11 countries, including China, Brazil, and Saudi Arabia. With export contracts signed with 14 additional countries such as India and the UAE, Fexuprazan is poised for a global presence. ### Forward-Looking Statements This press release contains forward-looking statements that are based on the current beliefs and expectations of Daewoong Pharmaceutical's management. Factors that could cause or contribute to such differences include, but are not limited to: (1) Regulatory and governmental approvals: The approval process for pharmaceutical products is subject to extensive regulations and may involve uncertainties and delays. Any failure to obtain necessary approvals or the occurrence of delays in the approval process could adversely affect Daewoong Pharmaceutical’s business and results of operations; and (2) Clinical trials: The success of Daewoong Pharmaceutical's products depends on the results of clinical trials. The results of early clinical trials may not be indicative of the results of later-stage or larger-scale clinical trials.

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