Onconic Therapeutics Receives MFDS Approval for JAQBO, a New Treatment for Gastroesophageal Reflux Disease (GERD)

SEOUL, South Korea, April 25, 2024 /CNW/ -- Onconic Therapeutics, a leading biotechnology company in Korea, today announced that the Ministry of Food and Drug Safety (MFDS) of Korea has approved JAQBO (zastaprazan citrate) for the treatment of erosive gastroesophageal reflux disease (GERD) in adults.

JAQBO is a next-generation potassium competitive blocker (P-CAB) expected to become the new standard treatment in the market for gastric acid related diseases. JAQBO directly binds to proton pumps in a competitive manner to reduce gastric acid secretion. This novel mechanism allows quick onset of action regardless of the acidity level in the stomach, offering immediate symptom relief. In addition, longer duration of acid suppression with no food effect could provide a new paradigm in GERD treatment.

The MFDS approval of JAQBO is based on comprehensive results including the Phase III clinical trial across 28 sites in Korea. The study demonstrated JAQBO's effectiveness on erosive esophagitis, with a healing rate of 97.9% after 8 weeks of treatment. These results were presented at the United European Gastroenterology Week in October 2023.

Onconic Therapeutics aims to launch JAQBO this year after listing for National Healthcare Insurance Reimbursement in Korea. Domestic sales of JAQBO will be handled by Jeil Pharmaceutical, Onconic Therapeutics's parent company.

In March 2023, JAQBO was licensed out to Livzon Pharmaceutical Group, the leading seller of PPIs in China for development and commercialization, in a deal value of $127.5 million for Greater China.

Onconic Therapeutics is committed to enhancing gastrointestinal treatment and improving patient outcomes by expanding additional indications.

About Onconic Therapeutics

Onconic Therapeutics is a Korean leader in developing novel drugs. With a focus on innovative research and clinical excellence, Onconic Therapeutics is dedicated to improving patient outcomes and providing quality healthcare solutions for cancer and gastrointestinal disorders.

Forward-Looking Statement

This press release contains forward-looking statements that are based on our current expectations, forecasts, and assumptions. These statements involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected. Forward-looking statements include statements about our future financial performance, business strategy, plans and objectives. Factors that could cause such differences include but are not limited to economic conditions, market demand, competitive pressures, and regulatory changes. We undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release.

SOURCE Onconic Therapeutics