Onconic Therapeutics said its partner Livzon Pharmaceutical Group, the top gastroenterology company in China, has completed phase 3 clinical trials of the company’s novel potassium-competitive acid blocker (P-CAB) drug, zastaprazan (Korea brand: Jaqbo), and submitted a new drug application (NDA) to the National Medical Products Administration (NMPA) on Aug. 18.

Onconic and Livzon signed an exclusive licensing agreement in April 2023 granting rights for Greater China, including mainland China, Hong Kong, Macau, and Taiwan.

Under the deal, Onconic received an upfront payment of $15 million.

Livzon, which generates about 600 billion won ($432.4 million) annually from digestive disease medicines and reported total annual revenue of 2.4 trillion won, initiated its phase 3 program in December 2024, just one month after securing IND approval.

The trial was completed in only seven months, far faster than the usual one to several years required at this stage. Onconic stressed that the rapid progress now positions Jaqbo to enter China’s P-CAB market at an accelerated pace.

According to IQVIA, the global gastroesophageal reflux disease (GERD) market stood at about 30 trillion won in 2023 and is projected to expand to 40 trillion won by 2025.

China, the world’s largest GERD market, is estimated at 4 trillion to 6 trillion won. The local P-CAB segment, currently valued at 241.4 billion won, is expected to surge with a compound annual growth rate of 81.2 percent in 2024 as the market rapidly shifts from traditional proton pump inhibitors (PPIs) to newer P-CAB therapies.

Jaqbo was developed directly by Onconic Therapeutics and received marketing approval as Korea’s 37th homegrown novel drug in April 2024.

Since its launch in Korea in October 2024, the drug has posted rapid sales growth, surpassing 10 billion won in cumulative outpatient prescriptions within six months.

The therapy has already secured four overseas licensing and distribution agreements, expanding to 26 countries worldwide.

“Livzon has strong sales power in China’s gastroenterology market and is well positioned to accelerate the shift from PPIs to P-CABs,” an Onconic official said. “With the trial completed earlier than expected, the timeline for regulatory approval and commercial rollout is also moving forward, which will speed up revenue realization in the Chinese market.”