Onconic Therapeutics Receives Final Approval from Ministry of Food and Drug Safety
Just Five Months After Successful Phase 3 Trial in January
The 37th domestically developed new drug, Jakubojung (ingredient name: Zastaprazan Citrate), has successfully obtained approval for an additional indication, expanding its therapeutic scope.
Onconic Therapeutics announced on June 17 that Jakubojung, a new drug for the treatment of gastroesophageal reflux disease (GERD) based on the potassium-competitive acid blocker (P-CAB) mechanism, has received additional approval from the Ministry of Food and Drug Safety for the treatment of gastric ulcers.
As a result, Jakubojung has become a multi-indication treatment that can be prescribed as a monotherapy for both erosive GERD and gastric ulcers. Among P-CAB formulations launched in Korea, Jakubojung is the second to obtain an indication for the treatment of gastric ulcers.
Jakubojung was approved as a domestically developed new drug in April last year and was launched in the Korean market in October of the same year. The drug quickly gained market traction, securing its second approved indication just eight months after launch. Notably, just three months after launch, in January of this year, Jakubojung achieved successful results in a phase 3 clinical trial for gastric ulcers, and within only five months, obtained final approval for the additional indication. According to the company, this demonstrates both Jakubojung's clinical excellence and Onconic Therapeutics' expertise in development and regulatory capabilities.
The phase 3 clinical trial for Jakubojung's gastric ulcer indication was led by Professor Park Jongjae of the Department of Gastroenterology at Korea University Guro Hospital, and conducted at 39 major medical institutions nationwide, involving 329 patients with gastric ulcers. The study was a randomized, double-blind trial in which participants received either 20mg of Zastaprazan or 30mg of the comparator drug, Lansoprazole, once daily for either 4 or 8 weeks, with efficacy and safety compared and analyzed.
The results showed that, based on endoscopic evaluation at week 8, the cumulative healing rate in the Zastaprazan group was 100%, demonstrating the non-inferiority of Zastaprazan. Additionally, in the quality of life (QoL) assessment conducted at week 4 of treatment, the Zastaprazan group showed a statistically significant improvement in the 'anxiety and depression' category, indicating the potential to enhance the overall treatment experience.
According to the pharmaceutical market research firm UBIST, Jakubojung recorded prescription sales of 3.3 billion KRW in the fourth quarter of last year and 6.7 billion KRW in the first quarter of this year, reaching a cumulative prescription total of 10 billion KRW within six months of launch. Currently, Jakubojung is being actively prescribed at more than 100 major tertiary hospitals nationwide, and with this additional approval for the gastric ulcer indication, its growth is expected to accelerate further.
A representative from Onconic Therapeutics stated, "This expansion of indications is a meaningful result that once again demonstrates Jakubojung's excellent efficacy, patient compliance, and mechanistic differentiation."
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