HK Inno.N said on Wednesday that its gastroesophageal reflux drug, K-CAB (ingredient: tegoprazan) obtained approval from the Indonesian National Agency of Drug and Food Control (NADFC) on Oct. 7, following approvals in Mongolia, China, and the Philippines.

K-CAB, Korea's 30th novel drug, is a new potasium competitive acid blocker (P-CAB) for gastroesophageal reflux disease, and has entered 34 countries overseas, including six Southeast Asian countries, 17 Latin American countries, and five Eastern European countries, as well as China, the United States, and Canada. K-CAB is also under regulatory review in other countries, and is expected to accelerate global territorial expansion, said a company official.

The indication approved in Indonesia is for the treatment of non-erosive gastroesophageal reflux disease (GERD).

K-CAB is scheduled to be released in Indonesia next year. After its launch, marketing and distribution will be coordinated by Kalbe, a large Southeast Asian pharmaceutical company based in Indonesia.

K-CAB sells more than 100 billion won in outpatient prescriptions annually. It is characterized by its rapid efficacy within just 30 minutes after consumption, securing effectiveness and safety up to six months, if taken long-term.

HK Inno.N CEO Kwak Dal-won said, "As K-CAB has obtained a series of permits from the Philippines to Indonesia, we expect to stand out in the Southeast Asian GERD treatment market."

The Southeast Asian pharmaceutical market has demonstrated an average annual growth rate (AAGR) reaching about 8 percent from 2015 to 2019, with Korea contributing 5.3 percent. In particular, Indonesia's digestive ulcer solvent market is about 244.7 billion won ($170.9 million) as of 2021, the largest market in Southeast Asia. Consequently, K-CAB’s approval in Indonesia is expected to play an important role in targeting the Southeast Asian market, the company added.