New P-CAB Class GERD Drugs
K-CAB and Pexuclu Emerge as 'Cash Cow' Products
Domestic Generics Also in Active Development
[Asia Economy Reporter Myung-Hwan Lee] Domestic new drugs for gastroesophageal reflux disease (GERD) are gradually expanding their market as they continue to receive product approvals overseas.
HK Innoen recently obtained product approval from the Mexican Ministry of Health and Welfare for ‘K-CAB,’ a potassium-competitive acid blocker (P-CAB) class new drug for gastroesophageal reflux disease. With this, K-CAB has received its first product approval in the Latin American region, accelerating its market entry. Previously, on the 26th of last month, K-CAB signed a technology export contract with Eurofarma, a major pharmaceutical company in Brazil.
Daewoong Pharmaceutical’s P-CAB drug for gastroesophageal reflux disease, ‘Pexuclu,’ also obtained product approval in Ecuador, a Latin American country, on the 24th of last month. Pexuclu achieved its second success following product approval in the Philippines in November last year. Daewoong Pharmaceutical explained that product approval in Ecuador could positively influence approval reviews in neighboring Latin American countries.
P-CAB is a drug that improves upon the drawbacks of existing proton pump inhibitors (PPIs). It binds to the proton pump without activation by stomach acid, enabling fast and stable suppression of acid secretion. Previously, PPIs, whose efficacy had already been proven, were mainly used; however, these drugs had limitations such as needing to be taken 30 minutes before meals and causing nighttime heartburn due to acid secretion during sleep. In contrast, P-CAB drugs have the advantage of rapid onset after administration and can be taken regardless of before or after meals. Suppression of acid secretion also improves nighttime heartburn.
New drugs in the P-CAB class have recently seen rapid sales growth, becoming ‘cash cow products’ for pharmaceutical companies. HK Innoen announced last year that K-CAB recorded 125.2 billion KRW in outpatient prescription sales in 2022, a 14.2% increase compared to the previous year. With Phase 3 clinical trials underway in the United States and K-CAB being listed as an insurance-covered drug in China, HK Innoen expects the market expansion to accelerate. Daewoong Pharmaceutical, which recorded its highest-ever sales last year, also evaluated that Pexuclu, launched in July last year, has settled in the market by surpassing cumulative sales of 10 billion KRW within four months of launch. Daewoong Pharmaceutical expects the growth of the prescription drug sector to accelerate as prescriptions for gastritis indications of Pexuclu become active in the first half of this year.
Both HK Innoen and Daewoong Pharmaceutical plan to intensify their efforts to target overseas markets with P-CAB drugs. K-CAB, which is currently available in 35 countries overseas, was recently launched in the Philippines following China. Besides, K-CAB has received approval in four countries (Mongolia, Indonesia, Singapore, Mexico), and is under approval review or preparation in 26 countries including Vietnam. Daewoong Pharmaceutical has also signed technology export contracts for Pexuclu worth approximately 1.2 trillion KRW with 15 countries including China and the United States, and has entered a total of 19 countries to date.
As P-CAB drugs rise, domestic pharmaceutical companies are busy preparing to enter the generic drug market. Jeil Pharmaceutical and Ildong Pharmaceutical are conducting clinical procedures for P-CAB drugs. Some companies are seeking rapid market entry by filing patent trials. Samchundang Pharmaceutical, JW Pharmaceutical, SK Chemicals, Boryung, Shinpoong Pharmaceutical, Hanmi Pharmaceutical, and Huons have filed requests for a passive scope confirmation trial regarding the crystalline form patent of K-CAB. If this request is accepted by the Patent Trial and Appeal Board, they will be able to sell generic drugs starting in 2031.
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