Onconic Therapeutics said on the 29th that its Chinese partner Livzon Pharmaceutical Group has begun dosing the first patient in a phase 3 trial in China to secure the Helicobacter pylori (H. pylori) eradication therapy indication for the P-CAB (potassium-competitive acid blocker) class new drug "zastaprazan (domestic product name Ja Q Bo tablets)."
Accordingly, Onconic Therapeutics secured an additional $1 million (about 1.5 billion won) in development milestones.
The trial is a follow-up development project pushed forward after Livzon Pharmaceutical Group filed for marketing approval in Aug. last year with the National Medical Products Administration (NMPA) of China for the erosive gastroesophageal reflux disease indication.
By proceeding with the approval process and additional indication development in China at the same time, the companies have laid the groundwork to quickly expand the scope of prescriptions after commercialization, according to assessments.
China is considered the largest single market within the global gastroesophageal reflux disease treatment market. The industry estimates the Chinese market at about 6 trillion won.
Local partner Livzon Pharmaceutical Group is a major Chinese drugmaker with annual sales of 2.4 trillion won. It is a powerhouse in gastrointestinal therapeutics, generating more than 600 billion won a year in the PPI gastrointestinal therapeutics segment.
According to a disclosure by Livzon Pharmaceutical Group to the Hong Kong Exchanges and Clearing (HKEX), the trial will use a four-drug regimen combining zastaprazan with the antibiotics amoxicillin and clarithromycin and the gastric mucosal protectant potassium bismuth citrate. Livzon Pharmaceutical Group already holds products for clarithromycin and potassium bismuth citrate, making it likely the company can pursue a strategy to expand prescriptions in connection with its existing gastrointestinal portfolio.
Ja Q Bo is also growing rapidly in Korea. According to drug market research firm UBIST, Ja Q Bo tablets recorded 8.519 billion won in out-of-hospital prescriptions in Apr. this year. In just 1 year and 7 months since launch, it rose to No. 2 in the domestic P-CAB market, and surpassed 21.2 billion won in quarterly prescriptions in the sixth quarter after launch. Cumulative out-of-hospital prescriptions from its Oct. launch last year through Apr. this year totaled 81.347 billion won.
Onconic Therapeutics signed an exclusive technology transfer deal for Greater China worth a total of $127.5 million with Livzon Pharmaceutical Group in 2023. Since then, it has received the 20 billion won upfront payment and has been receiving development and approval milestones related to the erosive gastroesophageal reflux disease indication in stages.
The company said it also expects additional milestone inflows going forward. Livzon Pharmaceutical Group is concurrently conducting a clinical trial of an injectable formulation of zastaprazan for the treatment of bleeding from peptic ulcers.
A representative of Onconic Therapeutics said, "In China, the approval process for gastroesophageal reflux disease and the development of additional indications are proceeding without a hitch," and added, "We expect to replicate overseas the growth trajectory proven in the domestic market and step up as a global new drug."