Onconic Therapeutics' Jakubo Enters Phase 3 Clinical Trials in China
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Onconic Therapeutics has announced that its drug Jakubo has entered Phase 3 clinical trials in China. This development may have significant implications for investors and pharmaceutical teams.
Onconic Therapeutics' Jakubo (zastaprazan / JAQBO / JP-1366) is a potassium-competitive acid blocker, not an oncology drug. In China, partner Livzon has an accepted New Drug Application for reflux esophagitis and NMPA clearance to run an H. pylori combination trial—building on a March 2023 Greater China license and Korea’s April 2024 MFDS approval.
Contents10 sections
Key Takeaways
- Zastaprazan is a P-CAB for acid-related disease; Korea approved JAQBO for erosive GERD on April 25, 2024.
- Livzon’s March 10, 2023 license: US$15 million upfront and milestones capped at US$112.50 million for Greater China.
- China GERD tablet NDA was accepted in August 2025 after Phase III work that Livzon said took under eight months from first subject to filing.
- On April 10, 2026, Livzon disclosed NMPA Notice No. 2026LP01115 approving a clinical trial of JP-1366 plus antibiotics for H. pylori eradication.
What is Onconic’s Jakubo, and why does China matter?
Jakubo / JAQBO is the Korean brand for zastaprazan (JP-1366), a P-CAB that competitively blocks the gastric proton pump. A July 2024 Drugs “First Approval” summary on PubMed places the South Korea approval on April 24, 2024, for erosive GERD and notes further Phase III work in gastric ulcer and NSAID-ulcer prevention.
China is a priority commercialization market because Livzon already sells gastrointestinal products and can pair acid suppression with its own antibiotic and bismuth lines in H. pylori regimens.
What did Korea’s MFDS approve in April 2024?
In a April 25, 2024 PR Newswire release, Onconic said MFDS approved JAQBO (zastaprazan citrate) for erosive GERD in adults. The company cited Phase III data from 28 Korean sites and a 97.9% healing rate after eight weeks of treatment, with results presented at United European Gastroenterology Week in October 2023.
- Approval date disclosed: April 25, 2024 (company release)
- Phase III footprint: 28 sites in Korea
- Eight-week healing rate cited: 97.9%
How is the Livzon–Onconic China license structured?
Livzon’s March 10, 2023 Hong Kong Exchange voluntary announcement says Onconic granted exclusive rights to develop, manufacture, and commercialize zastaprazan in mainland China, Hong Kong, Macau, and Taiwan.
Cash terms in that filing: a non-refundable US$15 million upfront license fee, plus technology-transfer and development/commercial milestones not exceeding US$112.50 million in aggregate, plus post-approval sales royalties. That structure is the primary source for the ~US$127.5 million headline deal value often quoted in secondary reports (15 + 112.5).
What China Phase 3 and filing progress has Livzon confirmed?
In 2025 interim materials, Livzon said JP-1366 tablets completed Phase III for reflux esophagitis and that the marketing application was submitted and accepted; it also said first-subject-to-filing took less than eight months. An August 2025 acceptance of the reflux esophagitis marketing application is restated in later notices.
Separately, Livzon’s April 10, 2026 HKEX announcement reports NMPA Notice No. 2026LP01115 approving a clinical trial of JP-1366 Tablet “in combination with appropriate antibiotics for the eradication of Helicobacter pylori.” The planned regimen named in that filing is JP-1366 with amoxicillin, clarithromycin, and bismuth potassium citrate.
How do related H. pylori studies frame the science?
Outside China, Samsung Medical Center listed NCT07115173 on ClinicalTrials.gov as a Phase 4, single-arm study of zastaprazan 20 mg twice daily plus clarithromycin and amoxicillin for 14 days in H. pylori infection, with estimated enrollment of 103 participants. That registry record is Korea-based and is not the Livzon China program, but it shows active clinical interest in zastaprazan-based eradication regimens.
What remains unproven for China commercialization?
As of the April 10, 2026 NMPA trial-approval notice, Livzon had clearance to study the H. pylori quadruple regimen; that filing does not by itself publish Phase 3 sample size, primary endpoint timing, or eradication rates. The reflux esophagitis NDA acceptance also does not equal approval.
Investors should wait for NMPA approval letters, disclosed Phase 3 protocols, and eradication-rate readouts before treating China revenue as locked. Secondary Korean press reports of May 2026 first-patient dosing and a US$1 million milestone are not restated here without a matching exchange filing.
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Frequently Asked Questions
What is Jakubo (zastaprazan) approved for in Korea?
On April 25, 2024, Onconic said Korea’s MFDS approved JAQBO (zastaprazan citrate) for erosive GERD in adults, citing a Phase III program across 28 Korean sites with a 97.9% healing rate at eight weeks.
What China rights does Livzon hold for zastaprazan?
On March 10, 2023, Livzon licensed exclusive Greater China rights to zastaprazan (JP-1366) from Onconic, with a US$15 million upfront fee and development plus commercial milestones not exceeding US$112.50 million in aggregate.
What China regulatory steps are confirmed for JP-1366?
Livzon said the marketing application for JP-1366 tablets in reflux esophagitis was accepted in August 2025, and on April 10, 2026, it announced NMPA clinical-trial approval to study JP-1366 with antibiotics for Helicobacter pylori eradication.
Primary Sources
- HKEX: Livzon NMPA clinical-trial approval for JP-1366 H. pylori regimen (April 10, 2026)
- HKEX: Livzon–Onconic zastaprazan license agreement (March 10, 2023)
- PR Newswire: MFDS approval of JAQBO (April 25, 2024)
- PubMed: Zastaprazan First Approval
- ClinicalTrials.gov: NCT07115173 zastaprazan H. pylori study
Sources & references 1 primary sources
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