Bora Pharmaceuticals and South Korea-based Onconic Therapeutics have entered into a manufacturing agreement to support the U.S. clinical development of JAQBO, an investigational potassium-competitive acid blocker (P-CAB) for the treatment of gastroesophageal reflux disease (GERD).
The collaboration will support preparations for Onconic’s planned Phase 3 clinical trial in the United States, with Bora providing manufacturing services as well as quality control, stability testing, and regulatory documentation required for the clinical program.
The agreement highlights growing efforts by international pharmaceutical companies to expand innovative gastrointestinal therapies into the U.S. market, where GERD affects an estimated 20% of the population.
GERD is a chronic digestive disorder in which stomach acid frequently flows back into the esophagus, causing symptoms such as persistent heartburn, acid reflux, chest discomfort, and difficulty swallowing. Left untreated, the condition can lead to complications including esophageal inflammation, ulcers, and Barrett’s esophagus.
Although proton pump inhibitors (PPIs) have long been the standard treatment for GERD, newer potassium-competitive acid blockers (P-CABs) are attracting increasing interest because they offer faster onset of action and more sustained suppression of stomach acid production.
JAQBO belongs to this newer class of medicines and was independently developed by Onconic Therapeutics.
The therapy received regulatory approval in South Korea in April 2024, becoming the country’s 37th domestically developed innovative medicine. Following its commercial launch in October 2024, the company said JAQBO has experienced steady prescription growth in the Korean market while also securing commercialization and development partnerships in several international markets.
Under the newly announced agreement, Bora Pharmaceuticals will manufacture JAQBO tablets at its recently established oral solid dosage (OSD) manufacturing facility in Maple Grove, Minnesota.
In addition to manufacturing clinical trial supplies, Bora will conduct quality control testing, stability studies, and prepare chemistry, manufacturing, and controls (CMC) documentation required to support regulatory submissions for the planned U.S. Phase 3 program.
CMC documentation forms a critical component of regulatory filings by demonstrating that a medicine can be consistently manufactured to meet established quality standards throughout clinical development and commercialization.
Bora said the collaboration reflects its broader strategy of helping pharmaceutical and biotechnology companies navigate complex manufacturing requirements as they expand into highly regulated markets such as the United States.
Bobby Sheng, Chairman of Bora Group and Chief Executive Officer of Bora Pharmaceuticals, said selecting the right manufacturing partner can significantly influence the pace of clinical development.
“For companies preparing for U.S. clinical development and eventual commercialization, having the right manufacturing partner can make a meaningful difference in how quickly a program advances,” Sheng said. “We are proud to support Onconic as it prepares JAQBO for U.S. clinical development, and this collaboration demonstrates Bora’s commitment to helping innovative companies confidently enter highly regulated markets.”
Onconic Therapeutics described the agreement as an important milestone in preparing the therapy for global expansion.
A company representative said the collaboration establishes the manufacturing, quality, and stability package needed to support U.S. clinical development while strengthening the product’s long-term international competitiveness.
“Based on JAQBO’s prescription growth in Korea and our overseas commercialization achievements, we will continue preparing for U.S. clinical development without delay while strengthening the product’s global competitiveness,” the company said.
For Bora Pharmaceuticals, the agreement further expands its global contract development and manufacturing organization (CDMO) business. The company has continued investing in manufacturing infrastructure to support drug developers from early clinical development through commercial production.
The collaboration also reflects increasing global interest in P-CAB therapies, which are emerging as potential alternatives to conventional acid-suppressing medications. Researchers believe the class may offer faster symptom relief and longer-lasting acid control, potentially improving treatment outcomes for patients whose symptoms are not adequately managed with existing therapies.
As Onconic advances JAQBO toward U.S. Phase 3 testing, the partnership with Bora is expected to provide the manufacturing and regulatory support necessary to move the program through late-stage clinical development. If successful, JAQBO could become another treatment option for millions of patients living with GERD while expanding the global presence of Korea-developed innovative medicines in the gastrointestinal disease market.