Pharmaceutical Companies Accelerating P-CAB Development... Can They Catch Up with K-CAB?

Domestic pharmaceutical companies are advancing overseas and applying for product approvals for new drugs in the potassium-competitive acid blocker (P-CAB) class for gastroesophageal reflux disease. This is due to the expectation of significant market growth potential, thanks to the convenience of administration compared to existing treatments.

HK Innoen's new drug for gastroesophageal reflux disease, K-CAB.
[Photo by HK Innoen]

Daewoong Pharmaceutical Pexuclu 40mg.
[Photo by Daewoong Pharmaceutical]

According to industry sources on the 8th, Daewoong Pharmaceutical agreed on the 5th to terminate the exclusive license agreement with the U.S. pharmaceutical company Neurogastrics, which holds the clinical and commercialization rights for fexuprazan in the U.S. and Canada. At the same time, Daewoong Pharmaceutical announced that it has entered negotiations with several multinational pharmaceutical companies capable of conducting clinical trials and development in large markets such as North America, Europe, and Japan. This strategy is interpreted as an effort to accelerate entry into global big markets, including North America, through contracts with new partners.

Fexuprazan is Daewoong Pharmaceutical's P-CAB class new drug substance for gastroesophageal reflux disease, marketed domestically under the name 'Fexuclu.' Launched in Korea in July last year, Fexuclu recorded outpatient prescription sales of 11.8 billion KRW in its first year alone. This means it surpassed 10 billion KRW in sales within just four months of launch. The company is also accelerating its overseas expansion. It has already obtained product approvals in Latin American markets such as Chile and Ecuador, as well as the Philippines, and plans to increase the number of countries submitting product approval applications to 20 within this year.

There are also companies preparing to enter the P-CAB market. Oncogenic Therapeutics, a subsidiary of Jeil Pharmaceutical, has begun preparations for launching a P-CAB new drug. Oncogenic Therapeutics submitted the product approval application for the P-CAB new drug 'Zastaprazan' to the Ministry of Food and Drug Safety on the 7th. If the review proceeds smoothly, it is expected to be launched domestically in 2024. Earlier, in March, Oncogenic Therapeutics signed a technology export contract worth 127.5 million USD (approximately 160 billion KRW) with the Chinese pharmaceutical company Livzon Pharmaceutical Group for Zastaprazan. Ildong Pharmaceutical has also entered phase 1 clinical trials domestically for its P-CAB new drug candidate 'ID120040002.'

The product with the highest prescription performance in the domestic P-CAB market is 'K-CAB' by HK Innoen, launched in 2019. K-CAB, Korea's first domestically developed P-CAB formulation, rapidly increased its sales after launch, surpassing 100 billion KRW in prescription sales within three years in 2021. At that time, K-CAB was the first single domestic new drug product to achieve 100 billion KRW in prescription sales. Last year, K-CAB's outpatient prescription sales reached 132.1 billion KRW, a 19.3% increase compared to the previous year. It has expanded into 35 countries overseas. In May last year, it also diversified its formulation by launching an orally disintegrating tablet that dissolves in the mouth without water.

The reason domestic pharmaceutical companies are actively launching P-CAB formulations and exporting technology is the advantage of easier administration compared to existing formulations. Proton pump inhibitors (PPIs), mainly prescribed for gastroesophageal reflux disease, must be taken 30 minutes before meals and cause nighttime heartburn symptoms due to acid secretion during sleep. In contrast, P-CAB formulations can be taken regardless of meal times and have relatively faster efficacy. Nighttime heartburn is also improved due to suppressed acid secretion.

Thanks to these advantages, the market share of P-CAB in the domestic peptic ulcer drug market has been increasing every year. The market share of P-CAB formulations in the domestic peptic ulcer drug market was 10% in the first quarter of 2021 and increased to 14.2% by the fourth quarter of 2022. Considering that the overall peptic ulcer drug market grew by 12.6% during this period, the sales volume of P-CAB formulations has increased even more.

As the market share of P-CAB formulations increases domestically, it is expected to replace PPI formulations in a short time. In Japan, where P-CAB treatments were introduced five years earlier than in Korea, the share of P-CAB treatments already exceeded 30% in 2020. The Japanese market opened when Takeda Pharmaceutical launched the P-CAB formulation 'Takecab' in 2014. The market share of P-CAB in Japan is expected to surpass 44% by 2030.

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