The 5th Overseas Approval Following Mongolia, China, Philippines, and Indonesia

HK Innoen "New GERD Drug K-CAB Approved in Singapore" View original image

[Asia Economy Reporter Myung-hwan Lee] HK inno.N announced on the 12th that its new drug for gastroesophageal reflux disease, K-CAB tablets, received marketing authorization from the Health Sciences Authority of Singapore on the 11th.


With this, K-CAB has obtained marketing authorization in five countries, following Mongolia, China, the Philippines, and Indonesia. Among the total of 34 countries where K-CAB has expanded overseas, it has secured approval in five, marking the third success in the Southeast Asian market.


The indications approved locally in Singapore include four categories: ▲treatment of erosive gastroesophageal reflux disease ▲treatment of non-erosive gastroesophageal reflux disease ▲treatment of gastric ulcers ▲and antibiotic combination therapy for Helicobacter pylori eradication in patients with peptic ulcers or chronic atrophic gastritis. The local product name is 'K-CAB,' and it is planned to be launched in Singapore within this year. Previously, HK inno.N signed an export contract with its Singaporean partner UITC in 2020.


The Southeast Asian pharmaceutical market, known as a 'Pharmerging Market,' is growing at an average annual rate of about 8%. HK inno.N has fired the starting signal to aggressively target the Southeast Asian market by consecutively obtaining marketing authorizations in Indonesia, the largest market in Southeast Asia, as well as the Philippines and Singapore.


Kwok Dal-won, CEO of HK inno.N, said, "K-CAB has achieved the remarkable feat of obtaining consecutive approvals in five countries, including Mongolia, China, and three Southeast Asian countries." He added, "Starting with the emerging pharmaceutical markets in Southeast Asia, we will expand into Asia, Latin America, Europe, and the Middle East, nurturing the 'K-new drug' K-CAB into a global blockbuster product active in the world market."


K-CAB is a domestic new drug recording over 100 billion KRW in annual outpatient prescription sales. It is characterized by rapid onset of efficacy within as short as 30 minutes after administration and securing efficacy and safety even with long-term use over six months.



Overseas, it has expanded into a total of 34 countries and was recently launched in the Philippines following China. Countries currently under approval review or preparation number 27, including Mexico, and two countries, including the United States and Canada, are developing local versions.


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

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