Daewoong Pharmaceutical said it has submitted a new drug application for Fexuclue 40mg (ingredient: fexuprazan), a potassium-competitive acid blocker (P-CAB) developed in-house, to the Center for Drug Evaluation under the National Medical Products Administration (NMPA) of China.

The P-CAB class of drugs, of which Fexuclue is a member, represents a new generation of gastroesophageal reflux disease (GERD) treatments that address the shortcomings of traditional proton pump inhibitors (PPIs), such as slow onset of action, dietary influences, and drug interactions. Pexuclo binds to the proton pump without activation by stomach acid and shows a rapid inhibition of gastric acid secretion.

Notably, it stably suppresses stomach acid regardless of pre- or post-meal and has the longest half-life of nine hours among GERD drugs.

Since its launch in Korea in July, Fexuclue has grown at an average rate of 15 percent per month, exceeding 30 billion won in cumulative prescriptions in 11 months, and is currently in talks with several multinational pharmaceutical companies to conduct clinical development in big markets such as North America, Europe, and Japan.

Daewoong confirmed the efficacy and safety of Fexuclue in a phase 3 clinical trial in 332 patients with erosive GERD in China.

As Daewoong has proved rapid onset of action, mucosal healing, and improvements in targeted clinical endpoints, including improvement in heartburn, cough, and acid reflux, the company expects the Chinese approval process to proceed smoothly.

"We believe that P-CABs will rapidly replace PPIs due to their ability to be effective in just one day, unlike PPIs, which take a long time to be effective, and their ability to be effective regardless of whether they are taken before or after meals," said Professor ‪Yao Xiao at Sun Yat-sen University, who conducted the phase 3 clinical trial in China. "Fexuclue will play a role in leading this trend."

Daewoong CEO Jeon Seng-ho also said, "Fexuclue's rapid approval submission in China, which has grown to be the world's largest market for anti-ulcer drugs, is a successful reflection of Daewoong's acceleration strategy."

Going forward, the company will increase the number of overseas product approval submissions to 30 countries by 2025 and achieve the goal of entering 100 countries by 2027 to develop Fexuclue into a global blockbuster drug, Jeon added.