HK Inno.N Proves the "K-CAB Effect," Sets Its Sights on the U.S.

Annual Sales Surpass 1 Trillion Won for the First Time... Profitability Also Improves
K-CAB NDA Submitted in the U.S.... Efficacy Proven in Phase 3
Upon Approval, P-CAB Competition with Vonoprazan

HK Inno.N has surpassed annual sales of 1 trillion won for the first time in its history. Centered on K-CAB, a treatment for gastroesophageal reflux disease, the company is assessed to have achieved both top-line growth and improved profitability. Market attention is now turning to the United States, the largest market.

According to the industry on February 12, HK Inno.N posted consolidated sales of 1.0632 trillion won and operating profit of 110.9 billion won last year. These figures represent increases of 18.5% and 25.7%, respectively, compared with a year earlier.

The core driver of performance is K-CAB. K-CAB is a potassium-competitive acid blocker (P-CAB) that offers faster onset of action than existing proton pump inhibitors (PPIs) and the convenience of dosing regardless of meals. In the domestic market last year, it recorded prescription sales of 217.9 billion won, capturing about 15% of the peptic ulcer drug market. In particular, royalty revenue from China nearly doubled year-on-year to about 14 billion won, significantly boosting its contribution.

The next battleground for K-CAB is the United States. HK Inno.N's U.S. partner, Sevella Pharmaceuticals, submitted a New Drug Application (NDA) for K-CAB to the U.S. Food and Drug Administration (FDA) last month through its subsidiary Braintree Laboratories. The indications are three in total: non-erosive gastroesophageal reflux disease (NERD), erosive esophagitis (EE), and maintenance therapy after treatment of erosive esophagitis.

In the U.S. Phase 3 trial (TRIUMpH), K-CAB met the non-inferiority endpoint versus the existing treatment lansoprazole and at the same time demonstrated statistical superiority in a 24-week maintenance regimen for patients with erosive esophagitis. It is also reported to have shown meaningful improvement in severe patient groups. In the non-erosive patient group, K-CAB demonstrated improvement in heartburn and reflux symptoms compared with placebo.

According to Sevella, there are about 65 million patients with gastroesophageal reflux disease (GERD) in the United States, and 35% to 54% of them fall into an "unmet need" group that does not achieve sufficient benefit from existing PPI therapy. Sevella stated, "The results of the Phase 3 TRIUMpH program for tegoprazan (K-CAB) demonstrated superiority over PPIs in terms of sustained treatment effect in erosive esophagitis and 24-hour relief of heartburn and reflux in patients with non-erosive gastroesophageal reflux disease."

The key differentiating factor from competing products is safety. In the U.S. market, Takeda Pharmaceutical of Japan has already introduced the P-CAB agent vonoprazan (brand name Voquezna), but its launch was delayed during commercialization due to issues related to the detection of nitrosamine impurities. By contrast, K-CAB is cited as being differentiated by its relatively low risk of nitrosamine formation due to its structural characteristics.

Jo Seeun, an analyst at Mirae Asset Securities, said, "Once FDA approval is obtained, prescription volume in the U.S. market is expected to expand based on accumulated clinical and prescription data, multiple indications, and efficacy superior to PPIs," adding, "as confirmed in the global commercialization issues surrounding Voquezna, ensuring long-term safety along with stringent quality control will be the most critical challenge."

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