Yuhan推进P-CAB仿制药和自研新药双轨策略

Yuhan Corporation is moving to capture the potassium-competitive acid blocker (P-CAB) market, which is growing rapidly as a treatment for gastroesophageal reflux disease. The company is pursuing a "two-track" strategy, laying the foundation for short-term market entry with a generic while simultaneously developing its own novel drug candidate. However, with time remaining until the generic's launch and existing products having secured an early market lead, the ability to differentiate its own novel drug is expected to be a key variable.
According to the pharmaceutical industry on the 3rd, Yuhan is developing 'YHC1139,' a candidate for reflux esophagitis, at the preclinical stage. While the company did not disclose specifics such as a target timeline for entering clinical trials, it plans to develop the drug as a P-CAB class novel drug to expand its gastrointestinal treatment portfolio.
Alongside novel drug development, the company is also preparing to launch a generic. In May this year, Yuhan received approval from the Ministry of Food and Drug Safety for 'Yuhan Bono Tablets' 10 mg and 20 mg, containing the ingredient vonoprazan. The product secured four indications, including treatment and maintenance therapy for gastric ulcers and erosive gastroesophageal reflux disease. Vonoprazan is a P-CAB class ingredient developed by Japan's Takeda Pharmaceutical, and the original product in Korea is Korea Takeda Pharmaceutical's 'Vocinti Tablets.' However, with Vocinti's substance patent remaining in effect until November 2028, the actual launch timing of Yuhan Bono Tablets could vary depending on patent disputes and whether the patent can be circumvented. This is interpreted as Yuhan securing product approval ahead of the patent's expiration to establish a bridgehead for future market entry.
"Development of the P-CAB class novel drug is at the preclinical stage, still in its early phase, so the timing for entering clinical trials has not been specified," a Yuhan official said. "As for the generic, we will likely decide whether to launch it around 2028, when the patent expires."
Yuhan previously received approval for 'Revanex,' a self-developed gastric ulcer treatment, as Korea's ninth domestically developed novel drug in 2005. Revanex was regarded as the world's first commercialized P-CAB class drug, but it failed to maintain market competitiveness as it produced no clear results in proving efficacy and expanding follow-up indications. The industry is watching whether Yuhan can regain influence in the P-CAB market by leveraging the research and development capabilities in the gastrointestinal field it has accumulated and its large sales organization.
Currently, P-CAB class drugs are rapidly replacing the existing proton pump inhibitor (PPI) market and increasing their share. The growth is driven by their rapid onset of action, fewer restrictions on timing relative to meals, and the sustained, powerful effect of suppressing gastric acid.
In fact, according to pharmaceutical market research firm UBIST, annual prescription sales of P-CAB class drugs in Korea surpassed 100 billion won in 2021, exceeded 200 billion won in 2023, and grew to 368.5 billion won last year. First-quarter prescription sales this year also reached 107.6 billion won, up 31.3% from the same period a year earlier, raising the possibility of surpassing 400 billion won for the full year. This is the result of the market expanding as a three-way competition formed, beginning with HK inno.N's 'K-CAB' in 2019, followed by Daewoong Pharmaceutical's 'Fexuclue' in 2022 and Onconic Therapeutics' 'Jaqbo' in 2024.
As the market has expanded, competition among latecomers is also intensifying. The vonoprazan products that Yuhan has entered number 71 items from 37 companies, including the original product, based on Ministry of Food and Drug Safety approvals. Generics of K-CAB and Fexuclue have also received 40 and 9 approvals, respectively. In the novel drug field, Daewon Pharmaceutical's 'DW4421' has entered Phase 3 clinical trials and Ilyang Pharmaceutical's 'IY-828026' has entered Phase 1, continuing their development. In addition, the existing K-CAB, Fexuclue and Jaqbo are also accelerating expansion of indications and formulations as well as overseas entry, so for Yuhan, successfully establishing itself in the generic market by leveraging its sales power and proving the differentiation of its follow-up novel drug are expected to be key tasks going forward.