Onconic Therapeutics said Sept. 23 that Livzon Pharmaceutical Group, its Chinese licensing partner, has begun the Phase 3 clinical trial of injectable zastaprazan, the P-CAB drug sold in South Korea under the brand name Zecuba, after dosing the first patient this month.
P-CABs (potassium-competitive acid blockers) are drugs that suppress gastric acid secretion by competing with potassium ions in the stomach’s parietal cells. Compared with existing proton pump inhibitors (PPIs), they have a faster onset of action and can be taken regardless of whether the patient has eaten.
The trial will evaluate the efficacy and safety of injectable zastaprazan in patients with peptic ulcer bleeding. Onconic Therapeutics has also issued an additional $1 million development milestone invoice to Livzon under the terms of the agreement.
An oral formulation of zastaprazan for the treatment of erosive gastroesophageal reflux disease (GERD) was submitted for regulatory approval to China’s National Medical Products Administration in August last year and is currently under review. A Phase 3 trial for H. pylori eradication therapy also began in May this year.
China is considered the largest single-country market for gastroesophageal reflux disease treatments globally. According to industry data citing IQVIA, the global GERD treatment market is worth about $26.7 billion, while China’s market is estimated at about $2.7 billion to $4 billion.
The partnership between the two companies is also generating tangible revenue as development progresses. Onconic Therapeutics signed a $127.5 million licensing agreement with Livzon covering Greater China in 2023 and received $15 million in upfront payments alone.
The company has since secured additional milestone payments as development has progressed. In August last year, it received an additional $5 million after completing a Phase 3 clinical trial in China and submitting an application for product approval to the NMPA. With major development milestones, including the Phase 3 trial of the injectable formulation, continuing to translate into milestone revenue, technology licensing gains from expanding indications and formulations are also gaining momentum.
An Onconic Therapeutics official said, “Based on our partnership with Livzon, which has a strong business foundation in China’s gastrointestinal market, the expansion of zastaprazan’s indications and formulations is progressing rapidly. We expect the drug’s commercial value in China to gain full momentum once it receives local regulatory approval.”
