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HK inno.N’s Drug Outperforms Standard Reflux Treatment in US Trial

Phase 3 success paves regulatory path for potassium-competitive acid blocker with FDA submission planned for Q4.
South Korea
h 195940.KQ Mid and Small Cap 2000
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HK inno.N Corp. shares jumped to their daily limit in Seoul trading after its gastroesophageal reflux disease drug demonstrated superior efficacy over existing treatments in a crucial US Phase 3 trial, bringing the Korean pharmaceutical closer to entering the world’s largest drug market.

The company’s US partner Sebela Pharmaceuticals reported this week that tegoprazan, marketed as K-CAB in Korea, met all primary and secondary endpoints for both erosive esophagitis and non-erosive reflux disease, outperforming the proton pump inhibitor lansoprazole in key metrics.

“Tegoprazan’s data suggests the P-CAB class can outperform PPIs,” noted Dr. Felice Schnoll-Sussman, professor at Weill Cornell Medical College, highlighting the drug’s potential advantages in the highly competitive reflux medication market.

The therapy is part of a newer drug class called potassium-competitive acid blockers (P-CABs), designed to act faster and more consistently than standard proton pump inhibitors. K-CAB has generated 705.4 billion won ($492 million) in prescriptions since its 2019 Korean launch.

Sebela plans to submit a New Drug Application to the FDA in the fourth quarter, targeting a US market for peptic ulcer treatments worth approximately 4 trillion won. Industry analysts estimate competing drug Vonoprazan could reach $1.9 billion in global sales by 2030.

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