Japan's Takeda Pharmaceutical's acid secretion inhibitor "Boequizna (bonoprazan)" has extended its patent rights in the United States, securing exclusive rights for the next 10 years. As a result, the potential for HK inno.N's same category new drug "K-Cap (ingredient name tegoprazan)" to compete in the U.S. market against Boequizna has significantly increased. During the period in which generic drugs are prohibited from being released, the two new drugs are expected to compete on efficacy without concerns about price reductions.
On the 7th (local time), the U.S. Food and Drug Administration (FDA) approved the consumer petition for the extension of exclusivity for Boequizna filed by Phathom Pharmaceuticals, its U.S. distributor. Consequently, Boequizna's exclusivity in the U.S. has been extended from 2027 to 2032.
Boequizna is the first approved potassium competitive acid secretion inhibitor (P-CAB) new drug in the United States. Since its launch in November 2023, it has quickly dominated the market, recording a cumulative prescription of 118,000 cases and net sales of 78.8 billion won within a year.
The first approved treatment disease for Boequizna in the United States is the eradication of Helicobacter pylori. Accordingly, the FDA designated Boequizna as a "Qualified Infectious Disease Product (QIDP)" to encourage the development of new antibiotic drugs, granting additional exclusivity benefits until May 2032.
Initially, Boequizna's exclusivity for other treatment target diseases such as gastric disease treatment and erosive and non-erosive esophagitis, excluding Helicobacter eradication, was set to 2027. However, Phathom requested that the same 10-year exclusivity apply to these diseases as well, just like for Helicobacter eradication, and the FDA accepted this. Therefore, Boequizna's generic versions cannot be released in the United States until 2032.
Thus, a key competitive variable for HK inno.N's domestic P-CAB new drug K-Cap, scheduled for release in the U.S. in 2027, has been eliminated. If generics are released, the price of the original drug is expected to drop to about 70% of its previous level, which will inevitably weaken the price competitiveness of other new drugs as well. This FDA decision has solidified the competitive structure between K-Cap and Boequizna.
HK inno.N previously completed a Phase 3 clinical trial for K-Cap in the United States through Braintree Laboratories, a subsidiary of the collaboration partner Sebela, last April. The company is currently preparing to submit a New Drug Application (NDA) to the FDA, with expectations for U.S. market launch in 2027 upon approval.
According to the Phase 3 results, K-Cap demonstrated superior efficacy in treating erosive esophagitis (EE) compared to existing treatments (PPIs), and showed significant improvement in heartburn and acid reflux symptoms in patients with non-erosive gastroesophageal reflux disease (NERD). This clinical result comes three years after the company transferred K-Cap's technology to Sebela in 2021.
However, the treatment target diseases for which K-Cap has been approved in the United States differ from those of Boequizna. While Boequizna has been approved for Helicobacter eradication as well as gastric and duodenal ulcers, and erosive and non-erosive gastroesophageal reflux disease, K-Cap's clinical trials have focused on treating erosive esophagitis and non-erosive gastroesophageal reflux disease.
Helicobacter pylori eradication is considered an important competitive point for P-CAB class acid secretion inhibitors. Helicobacter, which resides long in the gastric mucosa, can cause inflammation and progress to gastric ulcers and gastric cancer, necessitating early eradication treatment. The World Health Organization (WHO) has also classified Helicobacter as a Group 1 carcinogen. For this reason, there is a consistent demand for drugs for eradication treatment in the United States.
Generally, eradication treatments involve administering two types of antibiotics along with an acid secretion inhibitor. P-CAB class drugs, which have strong acid suppression, can yield advantageous effects in eradication treatment. Boequizna has been approved as the first P-CAB class drug for use in Helicobacter eradication treatment in the U.S., having obtained a 10-year exclusivity by being designated as QIDP during its development phase.
K-Cap has also been recognized for its effectiveness in Helicobacter eradication in some countries, including Korea, and has been included as a treatment target. However, the clinical trials in the U.S. were designed primarily around gastroesophageal reflux disease, rather than Helicobacter.
A representative of HK inno.N said, "The U.S. clinical trials and sales are managed by our local partner Sebela, and I'm aware that there are currently no additional clinical plans for expanding the indications related to Helicobacter." They noted, "Sebela has made strategic judgments considering the local market situation."
HK inno.N views pricing competitiveness and the partner's foothold in the U.S. gastrointestinal drug market as strengths of K-Cap. According to a recent report by Korea Investment and Securities, while the price of Boequizna is $22 (30,148 won), K-Cap's estimated price in the U.S. is $17 (24,325 won). Additionally, Sebela, which is responsible for K-Cap's sales and marketing in the U.S., is recognized as a specialist in gastrointestinal pharmaceuticals, with a strong presence in the local market.