HK inno.N has announced a significant step towards launching its gastroesophageal reflux disease (GERD) treatment, K-CAB (tegoprazan), in India. The company received a positive recommendation from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) of India, paving the way for potential market entry in a country with the world's largest population and a substantial market for peptic ulcer drugs.
The SEC's recommendation covers two dosages of K-CAB tablets: 25 mg and 50 mg. Specifically, the committee recommended approval of the 50 mg tablet for the treatment of erosive GERD, non-erosive GERD, and gastric ulcers. The 25 mg tablet received a recommendation for maintenance therapy following the treatment of erosive GERD.
"K-Cap is expected to receive approval for local permits next year after the recommendation of this India permit," said an official from HK inno.N, highlighting the anticipation for K-CAB's launch in India. The company also anticipates that K-CAB's influence will grow as it secures licenses and launches in other major global markets.
Market and Clinical Context
India, with its population of 1.45 billion, represents a significant market opportunity. It currently ranks as the fourth-largest market for peptic ulcer drugs globally, trailing only China, the United States, and Japan. This makes the potential approval of K-CAB particularly noteworthy for HK inno.N.
K-CAB, Korea's 30th new drug, was first launched in 2019 as a potassium-competitive acid blocker (P-CAB) for GERD. It distinguishes itself through its rapid onset of action, taking effect within an hour, and its demonstrated efficacy and safety for extended use of up to six months. These characteristics could offer advantages over existing treatments for GERD and related conditions.
Global Presence and Future Prospects
Currently, K-CAB is available in 46 countries, including Korea, China, the U.S., and various Latin American nations. Approval and launch procedures are actively underway in additional countries, signaling HK inno.N's commitment to expanding the drug's global reach. In Korea alone, K-CAB generated 160.2 billion won in outpatient prescriptions between January and October of this year, demonstrating its strong market performance.
In 2022, HK inno.N entered into export agreements with Dr. Reddy’s Laboratories, an Indian pharmaceutical company, covering seven countries, including India, South Africa, and Eastern Europe. This partnership is expected to facilitate the successful introduction and distribution of K-CAB in the Indian market, pending final regulatory approval.
The Subject Expert Committee (SEC) also suggested conducting a local phase 3 clinical trial for K-CAB in combination with antibiotics for Helicobacter pylori eradication therapy, citing limited global data and varying resistance patterns across countries. This highlights the importance of local data and the need to tailor treatment strategies to specific regional contexts.
