Onconic Therapeutics, a subsidiary of Jeil Pharma Holdings, said it received approval from the Ministry of Food and Drug Safety for Jaqbo (ingredient: zastaprazan), a drug for the treatment of gastroesophageal reflux disease (GERD) and Korea's 37th domestically developed new drug.

Jaqbo represents a new generation of drugs known as potassium-competitive acid blockers (P-CABs), expected to replace older proton pump inhibitors (PPIs) used in treating acid-related conditions.

PPIs have been the mainstay in such treatments for over three decades but have often been criticized for slow activation times, unstable drug interactions, and suboptimal suppression of nocturnal acid production.

In contrast, Jaqbo works by competitively inhibiting stomach acid secretion by blocking potassium ions' binding with proton pumps.

This mechanism allows for immediate therapeutic effects and is effective regardless of the stomach's acidity levels, offering significant improvements in convenience and effectiveness for patients.

The clinical trials that led to the approval involved 300 patients across 28 domestic medical institutions, highlighting Jaqbo's superior mucosal healing capabilities and safety profile.

Notably, the drug's benefits include rapid onset of action, typically within an hour of administration, and its ability to maintain gastric pH above 4 for 85 percent of the time over 24 hours.

“Zastapraza is expected to have a rapid onset of action and the highest rate of maintaining gastric pH above 4 for 24 hours among P-CAB preparations,” said Professor Jung Hwoon-yong at Asan Medical Center, who led the phase 3 clinical trials. “I expect the drug will help improve the symptoms of nighttime acid secretion with its excellent duration of action.”

Onconic Therapeutics CEO John Kim also said, “It is very meaningful and honorable that a specialized new drug research and development company such as Onconic Therapeutics has been able to achieve the final approval of a new drug from start to end, which was once the exclusive domain of large pharmaceutical companies.”

The company will do its best to further consolidate its position as a new drug research and development company that can further increase the value of K-drugs at home and abroad, Kim added.

Onconic Therapeutics aims to launch within the year after securing reimbursement. Jeil Pharmaceutical will be the domestic sales and distribution partner.