Korean pharmaceutical companies are actively conducting R&D to secure a share in the 21 trillion won ($18.1 billion) global gastric acid blocker market.

In foreign markets, they are particularly focusing on commercializing potassium-competitive acid blockers (P-CABs), the next-generation treatment for gastroesophageal reflux disease.

Korean pharmaceutical companies are accelerating R&D to tap the global gastric acid blocker market.
Korean pharmaceutical companies are accelerating R&D to tap the global gastric acid blocker market.

P-CABs reversibly block the proton pump that secrets gastric acid in the stomach wall.

Industry watchers said they might overcome the issues of slow action and the short duration of existing proton pump inhibitors (PPIs).

According to Target Addressable Market, the global gastroesophageal reflux disease market, including China, the U.S., and Japan, is about 21 trillion won. The U.S. market is the largest with 4 trillion won, followed by China. The Korean market is about 600 billion won.

Takeda Pharmaceutical’s vonoprazan (brand name: Takecab) is the most advanced in the global P-CAB development competition.

Phathom Pharmaceuticals, a spinoff from Takeda, conducts a phase 3 trial of vonoprazan in the U.S. In Korea, the medicine was released under the trade name, Vosinty.

Korean company inno.N developed tegoprazan (brand name: K-CAB), and Daewoong Pharmaceutical, fexuprazan. The two companies are conducting clinical trials overseas and clinching licensing deals to enter foreign markets.

inno.N, which developed the nation’s 30th novel drug K-CAB, has either licensed out the drug or exported the finished good to 24 countries. To sell the treatment in the U.S., the company is testing K-CAB in a phase 1 study.

Daewoong Pharmaceutical licensed out fexuprazan in the U.S., China, Brazil, Mexico, Colombia, Ecuador, Peru, and Chile.

In June, the company said cumulative technology transfer of fexuprazan exceeded 1 trillion won.

Daewoong plans to enter a phase 3 study of fexuprazan with its U.S. partner company Neurogastrx in 2022 and apply for FDA approval later.

Jeil Pharmaceutical has recently joined the competition in the gastroesophageal reflux disease market.

On Wednesday, the company said its subsidiary Onconic Therapeutics submitted to the Ministry of Food and Drug Safety an application for a phase 3 trial of investigational P-CAB, JP-1366. The drug aims to get an indication for erosive esophagitis in which the esophageal mucosa is damaged.

“As soon as we get the nod, we will start the phase 3 trial,” an official at Jeil Pharmaceutical said.

Along with a local phase 3 study, Jeil plans to conduct another phase 3 trial in Europe, too. The company said it recently obtained the certification from a qualified person (QP), proving that the production and distribution of a clinical drug met the criteria of Europe.

Onconic Therapeutics plans to submit a clinical trial application (CTA) to Europe’s regulatory agency for a phase 3 study in the fourth quarter.

“As Onconic Therapeutics pushes for a phase 3 trial of JP-1366 in Europe in the fourth quarter, the company will become the second after Takeda to enter a global phase 3 trial of P-CAB,” an official at Jeil Pharmaceutical said. “Through this, we will enhance global competitiveness in development and occupy a share of the large European reflux esophagitis market.”

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