Rapid Onset of Action, Excellent Nighttime Symptom Improvement, and Ease of Use
"Launching in 100 Countries Worldwide by 2030... Fostering a Global Blockbuster"
[Asia Economy Reporter Lee Gwan-joo] Daewoong Pharmaceutical has officially launched the 34th domestic new drug for gastroesophageal reflux disease treatment, 'Fexuclue (Fexuclue Tablets),' in South Korea.
Daewoong Pharmaceutical announced that on the 29th of last month, following the Ministry of Health and Welfare's notification, its self-developed new drug Fexuclue Tablets 40mg (active ingredient: Fexuprazan Hydrochloride) received insurance reimbursement approval for the indication of erosive gastroesophageal reflux disease and was simultaneously launched domestically on the same day.
Fexuclue Tablets is a purely domestic new drug developed entirely with Daewoong Pharmaceutical's proprietary technology, covering the full new drug development cycle from target molecule development in 2008 through research, clinical trials, approval, and sales. From the development stage, an optimal structure was designed to avoid risks such as liver toxicity during research and development.
Fexuclue Tablets is a P-CAB (Potassium-Competitive Acid Blocker) agent that improves upon the shortcomings of existing PPI (Proton Pump Inhibitor) drugs by binding to the proton pump without activation by gastric acid, thereby rapidly and stably suppressing gastric acid secretion. It is recognized as a new treatment in the gastroesophageal reflux disease market due to its strengths proven through clinical trials, including ▲rapid onset of action ▲quick and excellent symptom improvement ▲superior nighttime symptom relief ▲ease of administration ▲low drug interactions and consistent efficacy.
Daewoong Pharmaceutical plans to rapidly launch Fexuclue Tablets in the global market as well. Before domestic product approval at the end of last year, it signed technology export contracts worth approximately 1.1 trillion KRW with 15 countries worldwide, including China, the United States, and Brazil. As of the end of June, marketing authorization applications have been completed in eight countries: Brazil, the Philippines, Indonesia, Thailand, Mexico, Chile, Ecuador, and Peru.
Daewoong Pharmaceutical aims to launch Fexuclue Tablets in 10 countries by 2025 and in 100 countries by 2030 in the global market. The company plans to minimize the launch gap between the Korean market and major overseas countries and maximize the status of the original new drug product through the substance patent validity lasting at least until 2036, fostering it as a global blockbuster new drug.
Additional indications and formulations are also planned. Phase 3 clinical trials for gastritis have been completed, and Phase 3 trials for maintenance therapy after erosive gastroesophageal reflux disease treatment and prevention of ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs) are ongoing, with plans to continuously expand acid secretion-related indications.
Lee Chang-jae, CEO of Daewoong Pharmaceutical, said, “Fexuclue Tablets is the only purely domestic new drug P-CAB researched and developed with Daewoong Pharmaceutical’s proprietary technology and is the result of Daewoong’s long-term research and development efforts.” He added, “We aim to achieve cumulative sales of 100 billion KRW within one year of launch and lead a new wave in gastroesophageal reflux disease treatment, fostering it into a global blockbuster.”
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