HK Inno.N's gastroesophageal reflux disease treatment, K-Cab, is continuing its growth trajectory through expanded domestic prescriptions and international market entry. With increasing sales in China and anticipated U.S. approval early next year, the drug is poised for a significant global breakthrough. However, the expiration of its domestic patent is scheduled for the second half of 2031, and the exclusivity period in the U.S. will last only five years post-approval, making the development of a 'next K-Cab' a critical factor for the company's valuation.
According to industry sources, K-Cab has broadened its prescription base in the domestic gastroesophageal reflux disease market, achieving sales of 195.7 billion won last year, a 15.9% increase from the previous year.
The U.S. market entry is seen as the most significant growth opportunity. Partner company BrainTree submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in January. BrainTree estimates the U.S. P-CAB market size to be between $4 billion and $5 billion. If approved, HK Inno.N will receive milestone payments and, following commercialization, will secure sales milestones and royalty revenues.
In China, K-Cab tablets were launched in 2022. Sales from local partner Luoxin are estimated to have reached about 190 billion won last year, with projections of increasing to 280 billion won this year. Consequently, HK Inno.N's royalties are expected to rise from approximately 14 billion won last year to about 20 billion won this year. The launch of an injectable form in China is expected to extend the product's lifespan beyond the oral patent expiration in December 2031.
Discussions are ongoing for licensing agreements in Europe, where a 10-year regulatory exclusivity period applies post-approval, indicating long-term growth potential. However, the actual timing of revenue generation and the partner's sales capabilities will depend on contract terms and approval schedules.
The market views the future growth of K-Cab as entering a critical phase. The domestic patent expiration is set for the second half of 2031, and even if U.S. approval is granted in January 2027, the exclusivity period will only last five years, leading to anticipated generic competition starting in the second half of 2033. Following patent expiration, the entry of generics and subsequent products could pressure drug prices and prescription market share.
This urgency is why HK Inno.N is accelerating K-Cab's international expansion. The company needs to establish its brand and prescription base in key markets like the U.S. and Europe during the patent protection period while also achieving developmental milestones in its pipeline of successor products.
A notable successor in the pipeline is the GLP-1 receptor agonist IN-B00009, introduced by China's Saiwind Biosciences. It received approval in China in January and is currently undergoing Phase 3 clinical trials in South Korea. The JAK inhibitor IN-115314, being developed for atopic dermatitis, is in Phase 2 trials in South Korea and Phase 1b trials in the U.S. The animal adaptation has completed Phase 3 trials and is awaiting product approval, with a target launch this year.
Market analysts suggest that HK Inno.N's long-term growth hinges on the global commercialization success of K-Cab and the success of its new drug pipeline. Growth is expected to continue next year, with Mirae Asset Securities projecting HK Inno.N's revenue to increase by 8.7% to 1.186 trillion won and operating profit to rise by 10.9% to 150 billion won.
According to industry sources, K-Cab has broadened its prescription base in the domestic gastroesophageal reflux disease market, achieving sales of 195.7 billion won last year, a 15.9% increase from the previous year.
The U.S. market entry is seen as the most significant growth opportunity. Partner company BrainTree submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in January. BrainTree estimates the U.S. P-CAB market size to be between $4 billion and $5 billion. If approved, HK Inno.N will receive milestone payments and, following commercialization, will secure sales milestones and royalty revenues.
In China, K-Cab tablets were launched in 2022. Sales from local partner Luoxin are estimated to have reached about 190 billion won last year, with projections of increasing to 280 billion won this year. Consequently, HK Inno.N's royalties are expected to rise from approximately 14 billion won last year to about 20 billion won this year. The launch of an injectable form in China is expected to extend the product's lifespan beyond the oral patent expiration in December 2031.
Discussions are ongoing for licensing agreements in Europe, where a 10-year regulatory exclusivity period applies post-approval, indicating long-term growth potential. However, the actual timing of revenue generation and the partner's sales capabilities will depend on contract terms and approval schedules.
The market views the future growth of K-Cab as entering a critical phase. The domestic patent expiration is set for the second half of 2031, and even if U.S. approval is granted in January 2027, the exclusivity period will only last five years, leading to anticipated generic competition starting in the second half of 2033. Following patent expiration, the entry of generics and subsequent products could pressure drug prices and prescription market share.
This urgency is why HK Inno.N is accelerating K-Cab's international expansion. The company needs to establish its brand and prescription base in key markets like the U.S. and Europe during the patent protection period while also achieving developmental milestones in its pipeline of successor products.
A notable successor in the pipeline is the GLP-1 receptor agonist IN-B00009, introduced by China's Saiwind Biosciences. It received approval in China in January and is currently undergoing Phase 3 clinical trials in South Korea. The JAK inhibitor IN-115314, being developed for atopic dermatitis, is in Phase 2 trials in South Korea and Phase 1b trials in the U.S. The animal adaptation has completed Phase 3 trials and is awaiting product approval, with a target launch this year.
Market analysts suggest that HK Inno.N's long-term growth hinges on the global commercialization success of K-Cab and the success of its new drug pipeline. Growth is expected to continue next year, with Mirae Asset Securities projecting HK Inno.N's revenue to increase by 8.7% to 1.186 trillion won and operating profit to rise by 10.9% to 150 billion won.
* This article has been translated by AI.
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