[Bioscience] Domestic P-CAB gastrointestinal medicine Three Kingdoms… Targeting overseas markets

Entering into 27 to 55 countries each... Imminent arrival in the US after China

(Seoul = Yonhap News) Reporter Park Sang-hyun = Three new potassium-competitive gastric acid secretion inhibitor (P-CAB) drugs developed by domestic pharmaceutical companies are increasing their presence in the gastric acid suppressant market by rapidly increasing sales.

Domestic P-CAB products that are competing fiercely include 'K-Cap' by HK Innoen [195940], which was launched in 2019, 'Pexuclu', which Daewoong Pharmaceutical [069620] released on the market in 2022, and 'Jacubo', which was introduced by Onconic Therapeutics [476060], a subsidiary of Jeil Pharmaceutical [271980], in 2024.

◇ P-CAB, a sensation in the gastric acid inhibitor market… Faster efficacy compared to existing treatments

The P-CAB class treatment is a new drug that has appeared in the gastric acid suppressant market, which was dominated by the proton pump inhibitor (PPI) class treatment.

PPI and P-CAB have different modes of action in suppressing gastric acid secretion. P-CAB's efficacy appears faster than that of PPI. Additionally, PPI must be taken before meals, but P-CAB can be taken without worrying about meal times.

Domestic sales of P-CAB series treatments were approximately KRW 100 billion in 2021, but are expected to exceed KRW 400 billion this year. The overall market size for gastric acid suppressants is estimated at approximately 1 trillion won.

A pharmaceutical industry official said in a phone call with Yonhap News on the 10th, "Just because domestic pharmaceutical companies have developed new drugs one after another, it does not mean that it is easy to make P-CAB series treatments. There are also cases where famous overseas pharmaceutical companies stopped development due to toxicity issues."

He then pointed out, “As many Koreans suffer from gastrointestinal disorders due to spicy and hot foods, stress, etc., domestic pharmaceutical companies seem to be interested in P-CAB-based treatments.”

Among the three domestically produced P-CABs, the product with the most indications is the leader, K-CAB.

There are six indications for K-Cap, including erosive and non-erosive gastroesophageal reflux disease, gastric ulcer, and antibiotic combination therapy for Helicobacter pylori eradication.

Daewoong Pharmaceutical and Onconic are pursuing K-Cap by seeking to expand the indications for Fexuclu and Jacubo, respectively.

Looking at the trend of P-CAB outpatient prescriptions this year, K-CAB is unrivaled in first place, and Jacubo, which entered the market late, overtook Pexuclu in April.

Daewon Pharmaceutical [003220] and Ildong Pharmaceutical [249420] are also developing P-CAB new drug candidate 'Padoprazan', so competition in the P-CAB market is expected to intensify in the future.

◇ K-Cap, approved in the US as early as next year… Pexuclu will soon be launched in China

Pharmaceutical companies that produce P-CAB-based treatments are turning their attention beyond the Korean market to overseas markets.

K-Cap, which can be said to be the eldest brother, has entered 55 countries, including technology exports and finished product exports. K-Cap has been launched in 20 countries, including China, the Philippines, and Mexico, and is scheduled to be launched in Paraguay, Ecuador, Uzbekistan, and Belarus.

An HK InnoN official said, "Our goal is to export to 100 countries by 2028 and achieve global sales of 3 trillion won by 2030."

Pexuclu entered 30 countries and obtained product approval in 16 countries. It has been released in 9 countries, including Mexico, India, and the Philippines, and is expected to be released soon in China.

Jacubo, which has entered the market in 27 countries, obtained product approval in India last August and is imminent to be launched.

Companies are also accelerating their entry into the United States, the world's largest pharmaceutical market.

HK InnoN applied for product approval for K-Cap to the U.S. Food and Drug Administration (FDA) in January of this year, and is expected to be approved as early as next year.

Onconic is preparing for phase 3 clinical trials of Jacubo in the United States.

A pharmaceutical industry official said, “P-CAB-based treatments are likely to increase sales because they can replace PPI,” and added, “Good competition among domestic pharmaceutical companies is increasing the size of the P-CAB market.”

He added, “Companies are expected to pursue product approval and commercialization in major overseas markets based on the clinical evidence and market competitiveness accumulated domestically.”