HK inno.N's K-CAB Receives Approval in Malaysia

HK inno.N's novel drug for gastroesophageal reflux disease (GERD), K-CAB, has received marketing approval in Malaysia. HK inno.N announced on the 26th that K-CAB tablets (ingredient: Tegoprazan) were recently approved by Malaysia's National Pharmaceutical Regulatory Agency (NPRA). In 2021, the company signed a product export agreement with Malaysia’s top pharmaceutical company, Pharmaniaga, for K-CAB.

The approved indications in Malaysia include the treatment of erosive and non-erosive gastroesophageal reflux disease (GERD), gastric ulcers, and the use of antibiotic combination therapy for the eradication of Helicobacter pylori in patients with peptic ulcers or chronic atrophic gastritis.The local product name will be K-CAB, and it is scheduled for launch in the first half of next year.

K-CAB has expanded into a total of 46 countries, including the U.S. and China, with product launches in 9 of them. In Southeast Asia, it is being sold in major markets like the Philippines, Indonesia, and Singapore. The Southeast Asian market for peptic ulcer treatments is valued at approximately $520 million USD

HK inno.N CEO Dalwon Kwak stated, “K-CAB is accelerating its market leadership in key Southeast Asian countries. We aim to establish it as a leading P-CAB (Potassium-Competitive Acid Blocker) product in global markets, elevating the profile of Korean-made pharmaceuticals.”

As Korea’s 30th approved novel drug, K-CAB is a P-CAB-class treatment for GERD, offering rapid efficacy within one hour of administration, while ensuring effectiveness and safety even with long-term use over six months. Since its domestic launch in 2019, K-CAB has achieved cumulative prescription sales of 761.1 billion KRW (approximately $690 million USD) as of last month, maintaining its position as the No. 1 treatment in the peptic ulcer segment for four consecutive years.