inno.N

Jul 3, 2023
 

National Health Insurance to reimburse K-CAB’s H.pylori Eradication Indication Prescription  

HK inno.N's P-CAB class drug for gastroesophageal reflux disease, “K-CAB” (ingredient name: Tegoprazan), will have its national health insurance coverage expanded which will now include the H.pyolri eradication indication. With national health insurance reimbursement now applicable to all five indications of K-CAB, it has secured another growth momentum.

HK inno.N announced on Jul. 3rd that starting from Jul. 1st, K-CAB will be eligible for national health insurance coverage when used in combination therapy with antibiotics for Helicobacter pylori eradication in patients with peptic ulcers.

Helicobacter pylori (hereinafter referred to as “H. pylori”) is a bacterium known to primarily infect the gastric mucosa, leading to conditions such as chronic gastritis, gastric ulcers, duodenal ulcers, gastric adenocarcinoma, and gastric lymphoma.

Primarily, H. pylori eradication therapy involves taking two types of antibiotics (amoxicillin and clarithromycin) along with proton-pump inhibitors (PPI) twice a day for 7 to 14 days.

With this expanded national health insurance coverage, K-CAB will now be covered by the national health insurance program when used in combination therapy with antibiotics for H. pylori eradication in patients with peptic ulcers.

According to the Korean College of Helicobacter and Upper Gastrointestinal Research, it is estimated that around 50% of people worldwide are infected with H. pylori. Therefore, they particularly recommend eradication therapy for patients with gastric and duodenal ulcers.

Dal Won Kwak, CEO of HK inno.N, stated, “With the major national health insurance reimbursement criteria that applies to PPI drugs also being applied to K-CAB, a P-CAB class new drug, we expect to expand our activities in the gastrointestinal reflux disease therapeutics market, which exceeds KRW 1 trillion annually in South Korea.” He added, “We will continue to steadily expand the scope of K-CAB's indications, conduct differentiated studies, and pursue overseas expansion to solidify our position as a leader in the gastroesophageal reflux disease therapeutics market.”

HK inno.N's K-CAB is a P-CAB class for treating gastroesophageal reflux disease. It has the most indications among the same class of therapeutics in South Korea, including ▲erosive gastroesophageal reflux disease, ▲non-erosive gastroesophageal reflux disease, ▲gastric ulcer, ▲antibiotic combination therapy to eradicate helicobacter pylori in patients with peptic ulcer/chronic atrophic gastritis, and ▲maintenance therapy after treatment of erosive reflux disease.

K-CAB has entered 35 countries, including the USA and China, and has completed its launch in China, the Philippines, Mongolia, and Mexico.

It is awaiting approval in two countries and undergoing regulatory review in five. In the United States, the world's largest pharmaceutical market, K-CAB, is undergoing phase 3 clinical studies.

In the domestic market, it was launched in two formulations, tablets (25 mg and 50 mg) and orally disintegrating tablets (50 mg) and recorded annual sales of KRW 132.1 billion in the past year and KRW 60.7 billion from January to May this year through outpatient prescriptions. (End)

[Reference]

▶PPI (Proton Pump Inhibitor)

▶P-CAB (Potassium Competitive Acid Blocker)

▶Korean College of Helicobacter and Upper Gastrointestinal Research, Helicobacter Infection, https://www.hpylori.or.kr, 2023

▶The domestic market size for peptic ulcer medications (including PPIs and P-CABs) (based on outpatient prescription)

: KRW 1 trillion 64.4 billion in 2021 {2} KRW 1 trillion 164 billion in 2022

▶Ministry of Health and Welfare Notification No. 2023-120, partial amendment of “Detailed Matters to the Application Standards and Methods of Health Care Benefits,” Ministry of Health and Welfare, 2023