Bora Pharmaceuticals Signs Manufacturing Agreement for Onconic’s JAQBO U.S. Phase 3 Trial

COMPANY PROFILE
  • Bora Pharmaceuticals and Onconic Therapeutics have signed a manufacturing agreement to support the planned U.S. Phase 3 clinical development of JAQBO, a potassium-competitive acid blocker (P-CAB) for gastroesophageal reflux disease (GERD).
  • Bora’s oral solid dose facility in Maple Grove, Minnesota, will provide manufacturing, quality control, stability testing, and chemistry, manufacturing, and controls (CMC) documentation to support the clinical program.

Bora Pharmaceuticals has entered into a manufacturing agreement with Onconic Therapeutics to support the planned U.S. Phase 3 clinical development of JAQBO, a potassium-competitive acid blocker (P-CAB) tablet for the treatment of gastroesophageal reflux disease (GERD). Under the agreement, Bora will provide CDMO and contract manufacturing services through its oral solid dose (OSD) facility in Maple Grove, Minnesota.

The Maple Grove site will manufacture JAQBO for the planned U.S. clinical trial while also providing quality control, stability testing, and preparation of the related chemistry, manufacturing, and controls (CMC) documentation. The companies said these activities will support Onconic’s planned U.S. Phase 3 clinical program.

“We are proud to support Onconic as it prepares JAQBO for planned U.S. clinical development, and this collaboration reflects Bora’s commitment to helping innovative companies move with confidence into highly regulated markets.”

Bora Chairman and CEO Bobby Sheng

JAQBO was independently developed by Onconic Therapeutics and received approval in Korea in April 2024 as the country’s 37th domestically developed new drug. According to the company, the product has shown prescription growth in Korea since its launch in October 2024 and continues to expand its global development and commercialization partnerships.

The companies said the agreement supports Onconic’s preparations for U.S. clinical development while furthering Bora’s focus on supporting pharmaceutical and biotechnology companies with product development, manufacturing, and supply capabilities.

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