Ildong Pharmaceutical has begun preparing to commercialize a potassium-competitive acid blocker (P-CAB), known as a third-generation gastrointestinal drug. In the third-generation space, HK inno.N's K-CAB holds the No. 1 market share, with Daewoong Pharmaceutical's Fexuclue and JEIL PHARMACEUTICAL's Ja Q Bo competing. With Ildong Pharmaceutical entering as a latecomer, a four-way race is expected.
On the 6th, according to the pharmaceutical industry, Ildong Pharmaceutical recently signed a contract worth about 9.4 billion won to introduce the technology for the P-CAB candidate "padofrazan" from its subsidiary Unovia. Unovia is jointly developing a P-CAB candidate with Daewon Pharmaceutical and is in phase 3 clinical trials. Ahead of P-CAB commercialization, Ildong Pharmaceutical took over the padofrazan asset rights held by its subsidiary Unovia.
Earlier, in 2021, Ildong Pharmaceutical developed a P-CAB candidate and established its subsidiary Unovia, dedicated to new drug development, and completed phase 1 trials in 2023. After that, Daewon Pharmaceutical signed a license agreement and joined from phase 2, obtaining phase 3 approval in Oct. this year.
If Ildong Pharmaceutical and Daewon Pharmaceutical succeed in developing a third-generation gastrointestinal drug and obtain new drug approval, they can each make and sell different medications using the same substance. Global drugmakers also co-develop new drugs in this way and sell them separately. A person at Ildong Pharmaceutical said, "In Korea, we can introduce a different product based on the same clinical data as Daewon Pharmaceutical," adding, "We hold the overseas rights."
Gastroesophageal reflux disease, which affects 1 in 10 people in Korea, is a condition in which stomach acid flows up toward the pit of the stomach. In the past, first-generation treatments used antacids that neutralize gastric acid. Second-generation gastrointestinal drugs used proton pump inhibitors (PPI). They work by blocking the pump activity that secretes acid in the stomach lining. However, it takes time to block the pump, so it took 30 minutes after dosing for the effect to appear. The duration of action was short, causing nighttime heartburn when gastric acid is secreted during sleep.
The third-generation gastrointestinal drug P-CAB inhibits potassium action to block acid secretion. Its effect is fast, and it alleviates concern about nighttime heartburn. According to the pharmaceutical market research firm UBIST, domestic P-CAB prescriptions increased from 30.4 billion won in 2019 to 279.2 billion won last year.
K-CAB, the 30th domestically developed new drug introduced by HK inno.N in 2019, holds the No. 1 market share in the P-CAB market. K-CAB recorded cumulative prescriptions of 810 billion won in the first half of this year. As of the third quarter this year, it accounts for one-fifth of HK inno.N's sales. K-CAB has entered China, the Middle East, India and South America, and is aiming for U.S. Food and Drug Administration (FDA) approval.
Daewoong Pharmaceutical launched the country's 34th new drug, Fexuclue, in Jul. 2022. Fexuclue can be taken regardless of meals and has a long duration of action with a single dose. According to UBIST, Fexuclue posted cumulative sales of 219 billion won through Oct. this year. Following 40 mg and 10 mg, it recently added a 20 mg product, expanding the lineup.
JEIL PHARMACEUTICAL introduced Ja Q Bo, developed by its subsidiary Onconic Therapeutics, in Oct. last year. The reimbursed price is 911 won for 20 mg, which is relatively affordable. In Oct., for older patients, Ja Q Bo received approval from the Ministery of Food and Drug Safety in an orally disintegrating formulation that can be taken without water. In Aug., China received an application for marketing authorization for Ja Q Bo.
A pharmaceutical industry official said, "Demand for third-generation gastrointestinal drugs is increasing not only in Korea but also overseas," adding, "Competition to gain market share is intensifying as the market grows."