HK inno.N’s GERD treatment K-CAB approved in Malaysia

HK inno.N said Thursday that it has received regulatory approval for its gastroesophageal reflux disease (GERD) treatment, K-CAB (ingredient: tegoprazan), from Malaysia’s National Pharmaceutical Regulatory Agency (NPRA).

The approval follows a partnership established in 2021 with Malaysian pharmaceutical company, Pharmaniaga Logistic Sdn Bhd, for the export of K-CAB finished products.

K-CAB will be indicated for the treatment of erosive and non-erosive gastroesophageal reflux disease, gastric ulcers, and as part of combination therapy with antibiotics to eradicate Helicobacter pylori in patients with peptic ulcers and chronic atrophic gastritis.

The product will be marketed as K-CAB, with plans for a launch in Malaysia’s market slated for the first half of next year.

K-CAB tablets have now launched in 46 countries, including Korea, the United States, and China, with sales already recorded in nine of these markets. In Southeast Asia, K-CAB has entered the region’s six largest economies, such as the Philippines, Indonesia, and Singapore. The Southeast Asian market for digestive ulcer medications is estimated at approximately $520 million, positioning it as a region with “promising growth potential,” according to HK inno.N.

Recognized as Korea’s 30th new drug, K-CAB belongs to the potassium-competitive acid blockers (P-CAB) class and offers rapid efficacy within one hour of administration. It has proven effective and safe for long-term use of up to six months.

Since its domestic launch in 2019, HK inno.N said K-CAB has generated 761.1 billion won ($574 million) in external prescription sales by August this year, securing its status as the “top product” in the digestive ulcer medication market for four consecutive years. 

HK inno.N CEO Kwak Dal-won said that K-CAB’s expansion into major Southeast Asian markets is key to accelerating the company’s presence. “Beyond Southeast Asia, we aim to establish K-CAB as a leading product in the P-CAB category globally, enhancing the reputation of domestically developed drugs,” he said.