Bora to manufacture clinical trial supply of Onconic’s GERD drug
Bora Pharmaceuticals, headquartered in Taipei, Taiwan, has signed a manufacturing agreement with South Korea-based Onconic Therapeutics to produce clinical trial supplies for JAQBO tablets as the company prepares for a planned U.S. Phase 3 study in patients with gastroesophageal reflux disease (GERD).
According to the companies, Bora’s oral solid dose manufacturing facility in Maple Grove, Minnesota will manufacture and package the clinical trial drug product, while also providing quality control, stability testing, and chemistry, manufacturing and controls (CMC) documentation to support the U.S. clinical program.
JAQBO is a potassium-competitive acid blocker (P-CAB) developed by Onconic Therapeutics for the treatment of GERD. The companies said the manufacturing agreement is intended to support preparations for U.S. clinical development.
“This collaboration with a global CDMO is an important preparatory step in establishing the manufacturing, quality, and stability data package required for JAQBO’s U.S. clinical development,” an Onconic Therapeutics representative said in a statement. “Based on our prescription growth in Korea and overseas commercialization achievements, we will proceed with U.S. development preparation without delay and strengthen JAQBO’s global competitiveness.”
The agreement continues Bora’s expansion of its contract development and manufacturing organization (CDMO) business. Earlier this month, the company announced a potential $2.5 billion collaboration with Insilico Medicine to explore integrating artificial intelligence (AI) with pharmaceutical development and manufacturing.
According to the announcement, the partnership will evaluate AI-driven approaches for drug development planning, process optimization, manufacturing readiness, and quality systems across the product development lifecycle.
