Daewoong Pharmaceutical's New GERD Drug 'Pexuclu Tablets'... "Aiming Precisely at the P-CAB Market"

Official Release This Month... Developed with Purely Domestic Technology
Global Sales Expected through Technology Exports to 15 Countries

Daewoong Pharmaceutical Pexuclue Tablets.

[Asia Economy Reporter Lee Gwan-joo] Daewoong Pharmaceutical is attracting attention in the pharmaceutical industry as its first synthetic new drug, "Pexuclu Tablet," developed with its own technology, has been officially launched.

According to the pharmaceutical industry on the 8th, Daewoong Pharmaceutical successfully launched the new drug for gastroesophageal reflux disease (GERD), "Pexuclu" (active ingredient: Pexuprazan Hydrochloride), domestically on the 1st. It was registered with an insurance ceiling price of 939 KRW for erosive gastroesophageal reflux disease as the indication.

Daewoong Pharmaceutical introduced the first domestic biopharmaceutical in 2001, the diabetic foot ulcer treatment "EasyGF External Solution," and after 21 years, it has unveiled a self-developed new drug. Pexuclu is the first synthetic new drug developed by Daewoong Pharmaceutical. It is a purely domestic new drug developed entirely in Korea using Daewoong Pharmaceutical’s own technology from the target substance development stage through the entire R&D process. In particular, during the development stage, an optimal structure was devised to avoid risks such as liver toxicity.

Pexuclu is a P-CAB (Potassium-Competitive Acid Blocker) agent that reversibly blocks proton pumps. Unlike existing PPI (Proton Pump Inhibitor) class drugs, it does not require an activation process, allowing rapid onset of efficacy and a long duration of action. Clinical trials have also demonstrated superior effects in improving nighttime heartburn and pain symptoms compared to competing products. Another advantage is that it can be taken regardless of meals.

Leveraging these characteristics, Pexuclu is expected to form a full-fledged competitive structure in the domestic P-CAB market. Until now, HK Inno.N’s "K-CAB," containing the active ingredient Tegoprazan, was the only product in the domestic P-CAB market. With the launch of Pexuclu, the status of P-CAB agents is expected to rise further.

Daewoong Pharmaceutical has set a goal of achieving cumulative sales of 100 billion KRW within one year of Pexuclu’s launch and 300 billion KRW in cumulative sales by the third year. They plan to actively target the market by mobilizing extensive sales and marketing experience in gastrointestinal pharmaceuticals, including differentiated four-step verification marketing.

Global market achievements are also drawing attention. Pexuclu secured technology export contracts worth approximately 1.1 trillion KRW in 15 countries worldwide, including the United States, China, Brazil, starting with Mexico in 2020. Currently, New Drug Applications (NDAs) have been completed in eight countries, including Mexico, Chile, Ecuador, and Peru.

Lee Chang-jae, CEO of Daewoong Pharmaceutical, said, “The launch of Pexuclu will be an important opportunity to have the outstanding research and development (R&D) capabilities of Korea’s pharmaceutical industry recognized worldwide,” adding, “Starting with this launch, Daewoong Pharmaceutical will actively promote the excellence of Pexuclu through a differentiated four-step verification system and strong sales and marketing capabilities.” He continued, “We will actively enter not only the domestic but also the global market to establish Pexuclu as a global blockbuster.”

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