[Hinews] SEOUL, South Korea — Onconic Therapeutics (KOSDAQ: 476060), a South Korean biopharmaceutical company, announced that its gastroesophageal reflux disease (GERD) drug Zastaprazan, marketed as Zacubo, has successfully completed Phase 3 clinical trials in China, paving the way for a New Drug Application (NDA) submission to China’s National Medical Products Administration (NMPA). The milestone, achieved in collaboration with Chinese partner Livzon Pharmaceutical Group, signals Onconic’s accelerating push into the global GERD market, projected to reach $36 billion by 2025.

Livzon, China’s leading player in gastrointestinal therapeutics with annual revenues of approximately $2.2 billion and a market capitalization of $11 billion, wrapped up the Phase 3 trials in just seven months before submitting the NDA. The rapid timeline underscores the drug’s potential and Livzon’s robust clinical and regulatory capabilities.

Onconic Therapeutics CI (Provided by Onconic Therapeutics)
Onconic Therapeutics CI (Provided by Onconic Therapeutics)


Zastaprazan, a potassium-competitive acid blocker (P-CAB), was developed by Onconic and received approval from South Korea’s Ministry of Food and Drug Safety in 2023 as the country’s 37th domestically developed novel drug. Unlike proton pump inhibitors (PPIs), Zastaprazan offers faster onset and longer-lasting acid suppression, key advantages in treating GERD. Since its domestic launch, the drug has generated over $9 million in prescription sales within six months and secured export agreements with 26 countries.
In 2023, Onconic signed an exclusive licensing deal for Greater China with Livzon, receiving an upfront payment of $15 million, equivalent to roughly $13.5 million at current exchange rates. The agreement ranks among the largest technology transfer deals from South Korea in recent years.

According to market research firm IQVIA, the global GERD market is expected to hit $36 billion by 2025, with China accounting for $3.6 billion to $5.4 billion, making it the world’s largest single market for GERD treatments. While China’s P-CAB market is still in its early stages, it is growing at an annual rate of over 80%, driven by a rapid shift from PPIs to newer therapies like Zastaprazan.

“Livzon’s swift completion of the Phase 3 trials and NDA submission validates Zastaprazan’s market potential and competitive edge,” an Onconic spokesperson said. “Given the accelerating transition from PPIs to P-CABs in China, we expect revenue generation to commence sooner than anticipated.”

The GERD market’s scale surpasses even the obesity treatment market, recently valued by Morgan Stanley at $18 billion. As Zastaprazan expands globally, industry observers are watching whether Onconic can establish a new benchmark for South Korean biopharmaceuticals in commercializing novel drugs.
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