Onconic Therapeutics' Jaqbo Enters Phase 3 Trial for Injectable Formulation in China

[Financial News] Onconic Therapeutics' gastroesophageal reflux disease treatment Jaqbo (active ingredient: Jastaprazan) is expanding its push into the Chinese market by developing an injectable formulation in addition to the oral formulation. Its Chinese partner, Livzon Pharmaceutical Group, has begun a Phase 3 trial of the injectable formulation after undergoing a marketing authorization review for the oral formulation and conducting a clinical trial for Helicobacter pylori eradication therapy.
Onconic Therapeutics said on the 23rd that Livzon Pharmaceutical Group began dosing the first patient in a Chinese Phase 3 trial of Jastaprazan's injectable formulation this month. The trial will evaluate the efficacy and safety of the injectable formulation in patients with peptic ulcer bleeding. Under the terms of the agreement, Onconic Therapeutics also claimed an additional development milestone worth $1 million.
The oral formulation of Jastaprazan is being developed to treat erosive gastroesophageal reflux disease. Onconic Therapeutics applied for marketing authorization from China's National Medical Products Administration (NMPA) in August last year, and the application is currently under review. In May, the company also entered a Phase 3 trial for Helicobacter pylori eradication therapy.
Livzon Pharmaceutical Group is pursuing a dual-formulation strategy linking the oral and injectable products. The company plans to broaden Jastaprazan's use in China by expanding its indications beyond gastroesophageal reflux disease treatment to include Helicobacter pylori eradication and peptic ulcer bleeding.
China is considered the largest single-country market in the global gastroesophageal reflux disease treatment market. According to industry data, the global market is worth about 40 trillion won, while the Chinese market is estimated at approximately 4 trillion to 6 trillion won. Livzon Pharmaceutical Group, a local drugmaker that generates more than 600 billion won in annual revenue from digestive disease treatments, has established sales and distribution networks in China.
The partnership between Onconic Therapeutics and Livzon Pharmaceutical Group is also generating milestone revenue in stages. The two companies signed a technology transfer agreement covering Greater China worth a total of $127.5 million in 2023. After receiving an upfront payment of $15 million, Onconic Therapeutics secured an additional $5 million milestone last August upon completion of the Chinese Phase 3 trial and submission of the marketing authorization application to the NMPA. With the launch of the injectable formulation's Phase 3 trial, the company also claimed a development milestone worth $1 million.
An Onconic Therapeutics official said, "By partnering with Livzon, which has established a business base in China's digestive disease market, the expansion of Jastaprazan's indications and formulations is progressing rapidly. We expect Jastaprazan's commercial value in the local market to come fully into play following marketing authorization in China."
[email protected] Sang-hee Jeong Reporter