Daewoong Pharmaceutical "Pexuclu Aims to Enter 100 Countries by 2027"

New P-CAB Class GERD Drug
Surpasses 10 Billion KRW Sales in First Year
Approved in Two Countries Within 8 Months
Targets Overseas Markets Through Technology Export

[Asia Economy Reporter Myunghwan Lee] Daewoong Pharmaceutical's new drug for gastroesophageal reflux disease, Pexuclu (Pexuprazan), has quickly established itself in the market by surpassing 10 billion KRW in sales in its first year of launch. Daewoong Pharmaceutical announced its goal to expand its presence from the current 19 countries to 100 countries by 2027 by targeting the global market.

Pexuclue 40mg. [Photo by Daewoong Pharmaceutical]

According to UbiStat, a pharmaceutical sample statistical information source, on the 22nd, Pexuclu recorded outpatient prescription sales of 11.8 billion KRW last year. It achieved cumulative sales of 10 billion KRW within just four months of its release. Daewoong Pharmaceutical explained, "This is the second time a domestically developed new drug has exceeded 10 billion KRW in outpatient prescription sales in its first year since K-CAB in 2018."

Pexuclu is a new drug in the potassium-competitive acid blocker (P-CAB) class developed independently by Daewoong Pharmaceutical. P-CAB agents are characterized by binding to proton pumps without activation by stomach acid, thereby inhibiting acid secretion quickly and stably. The drug acts rapidly after administration and can be taken regardless of before or after meals. It also has the advantage of improving nighttime heartburn due to suppressed acid secretion.

The response in overseas markets has been encouraging. Following the approval of the New Drug Application (NDA) in the Philippines just four months after its launch in November last year, Pexuclu also obtained marketing authorization in Ecuador earlier this year. This marks approval in two global countries within eight months of its domestic launch. Daewoong Pharmaceutical emphasized that Pexuclu is the new drug developed in Korea that has completed marketing authorization applications in the most countries within the shortest time after domestic approval. Daewoong Pharmaceutical plans to apply for marketing authorization in China, the world's largest anti-ulcer drug market worth approximately 4.2 trillion KRW, this year and aims to increase the number of countries submitting marketing authorization applications to 20 by the end of the year.

Daewoong Pharmaceutical is also accelerating technology exports. The company has secured technology export contracts worth about 1.2 trillion KRW with 15 countries including China and the United States through Pexuclu. Including four Southeast Asian countries (Vietnam, Indonesia, Thailand, Philippines) where it has local branch offices, Daewoong Pharmaceutical has entered a total of 19 countries. The company plans to focus on overseas market expansion with the goal of entering 100 countries worldwide by 2027.

To strengthen Pexuclu's competitiveness, Daewoong Pharmaceutical is conducting various clinical trials. Pexuclu is the only P-CAB class drug in Korea approved for the indication of 'gastritis' and has secured two indications: ▲erosive gastroesophageal reflux disease treatment and ▲improvement of gastric mucosal lesions in acute and chronic gastritis. Additionally, phase 3 clinical trials for ▲maintenance therapy after erosive gastroesophageal reflux disease treatment and ▲prevention of ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs) are underway. Furthermore, within this year, clinical trials for ▲non-erosive gastroesophageal reflux disease and ▲Helicobacter pylori eradication therapy are scheduled to begin, with investigator-initiated studies also underway.

A Daewoong Pharmaceutical official stated, "Pexuclu was developed from the early stages with overseas expansion in mind. Although the main clinical trials were conducted in Korea, additional research has demonstrated no racial differences in efficacy and effectiveness, which serves as an advantage when entering overseas markets."