Onconic Therapeutics said its gastroesophageal disease treatment Zaqbo has entered a Phase 3 clinical trial in China for an additional indication as a treatment for Helicobacter pylori eradication.
The company said on May 29 that its Chinese partner Livzon Pharmaceutical Group has begun dosing the first patient in a local Phase 3 trial aimed at expanding indications for zastaprazan to include H. pylori eradication therapy. Under the agreement, Onconic Therapeutics will receive a development milestone payment of $1 million, or about 1.5 billion won.
The latest trial follows Livzon’s submission in August last year to China’s National Medical Products Administration (NMPA) seeking approval for zastaprazan’s first indication in the country, erosive gastroesophageal reflux disease (GERD).
The Phase 3 study will evaluate a four-drug regimen combining zastaprazan with the antibiotics amoxicillin and clarithromycin, as well as the gastric mucosal protectant potassium bismuth citrate.
In 2023, Onconic Therapeutics signed an exclusive licensing agreement with Livzon covering greater China worth a total of $127.5 million. The company has since received upfront payments and development milestone payments tied to erosive GERD, and will now secure an additional milestone payment tied to the Phase 3 entry for the new indication.
Livzon is also developing an injectable formulation of zastaprazan for the treatment of bleeding peptic ulcers.
An Onconic Therapeutics official said commercialization efforts for zastaprazan in China are progressing on two fronts — approval for GERD and development of additional indications — adding that entry into the Chinese market is expected to accelerate the company’s global expansion.
Backed by strong growth of Zaqbo, Korea’s 37th domestically developed new drug, Onconic Therapeutics posted first-quarter revenue of 22.98 billion won, operating profit of 4.59 billion won, and net profit of 6.42 billion won this year. Revenue from Zaqbo, excluding licensing income, rose 229% from a year earlier.