Onconic Therapeutics' Jakubo Enters Phase 3 Clinical Trials in China

Livzon Pharmaceutical Begins First Patient Dosing
Secures USD 1 Million Milestone

Onconic Therapeutics’ P-CAB class gastric acid secretion inhibitor, Zastaprazan (marketed in Korea as Jakubo), has entered Phase 3 clinical trials for its second indication in China.

Onconic Therapeutics Research Institute exterior view. Onconic Therapeutics

On May 29, Onconic Therapeutics announced that its Chinese partner, Livzon Pharmaceutical, has begun administering the drug to the first patient in a local Phase 3 clinical trial aimed at securing approval for the Helicobacter pylori (H. pylori) eradication therapy indication. As a result, a development milestone worth USD 1 million (approximately KRW 1,504,200,000) has been triggered.

This trial will be conducted as a four-drug regimen combining Zastaprazan with antibiotics such as amoxicillin and clarithromycin, as well as potassium bismuth citrate. Livzon Pharmaceutical owns some of the companion drugs as its own products, making it possible to pursue a strategy for expanding prescriptions in conjunction with its existing gastrointestinal treatment business.

Zastaprazan was submitted for approval for its first indication, erosive gastroesophageal reflux disease, to the National Medical Products Administration (NMPA) of China in August of last year. With the addition of this Phase 3 clinical trial for the H. pylori indication, the company is simultaneously working toward expanding both regulatory approval and indications in China.

China is considered one of the largest single markets in the global gastroesophageal reflux disease treatment sector. Livzon Pharmaceutical is a strong player in the Chinese gastrointestinal treatment market, recording annual sales of over KRW 600 billion from proton pump inhibitor (PPI) products.

In Korea, Jakubo continues to show strong growth. According to pharmaceutical market research firm UBIST, Jakubo posted outpatient prescription sales of KRW 8.5 billion in April this year, ranking second in the domestic P-CAB market. The cumulative outpatient prescription sales since its launch in October last year through April this year reached approximately KRW 81.3 billion.

Onconic Therapeutics signed an exclusive technology transfer agreement with Livzon Pharmaceutical for the Greater China region in 2023, worth a total of USD 127.5 million (approximately KRW 191,785,500,000). In addition to the upfront payment and development milestones for each stage, the company has now secured an additional milestone for entering the clinical trial for this new indication.

A representative from Onconic Therapeutics stated, "Commercialization efforts in China are progressing smoothly on both regulatory approval and indication expansion fronts. We aim to build on our domestic growth and expand into overseas markets to establish ourselves as a global new drug company."

This content was produced with the assistance of AI translation services.