Onconic Therapeutics announced on the 17th that its domestically developed drug for gastroesophageal reflux disease, "Ja Q Bo" (ingredient name: Jastaprazan citrate), has received additional approval for gastric ulcers from the Ministry of Food and Drug Safety.
"Ja Q Bo" is a potassium-competitive acid blocker (P-CAB) type treatment for gastroesophageal reflux disease that was approved in Korea last April. With this additional approval, it can now be prescribed alone for the treatment of gastric ulcers just eight months after its launch, following its previous approval for erosive gastroesophageal reflux disease. It is the second P-CAB product approved for the treatment of gastric ulcers in Korea, after "K-Cab" from HK inno.N.
The Phase 3 clinical trial for the gastric ulcer indication of "Ja Q Bo" was conducted under the leadership of Professor Park Jong-jae of the Gastroenterology Department at Korea University Guro Hospital, involving a total of 329 gastric ulcer patients at 39 major medical institutions nationwide. The efficacy and safety were compared and analyzed against lansoprazole as a control group, with the cumulative healing rate showing that "Ja Q Bo" achieved 100%, proving non-inferiority compared to lansoprazole. Additionally, the group treated with "Ja Q Bo" showed statistically significant improvements in terms of "anxiety and depression," indicating benefits extending beyond simple ulcer healing to overall treatment experience enhancement.
The company is conducting clinical trials to expand treatment indications to prevent gastric ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs) in addition to gastric ulcer treatment. Considering the characteristics of gastroesophageal reflux disease, where a significant portion of patients is elderly and may experience difficulties swallowing, the approval review for the orally disintegrating tablet (ODT) formulation, which can be conveniently taken without water, is also underway.
An official from Onconic Therapeutics noted, "This expansion of indication once again demonstrates the excellent efficacy and adherence of 'Ja Q Bo' and its mechanistic differentiation," and added, "Having secured a stable revenue base and experience in drug approval and technology, we will concentrate on the development of the subsequent anticancer drug pipeline 'Nesparib' to leap into a global biotech company."