Bora Pharmaceuticals and Onconic Therapeutics have entered into a manufacturing agreement to support the U.S. clinical development of JAQBO, a potassium-competitive acid blocker (P-CAB) tablet being developed for the treatment of gastroesophageal reflux disease (GERD).

Under the agreement, Bora's oral solid dosage (OSD) manufacturing facility in Maple Grove, Minnesota, will manufacture clinical trial supplies for the planned U.S. Phase III study. The facility will also provide quality control, stability testing, and prepare the required chemistry, manufacturing and controls (CMC) documentation to support the clinical programme.

JAQBO was independently developed by Onconic Therapeutics and received regulatory approval in South Korea in April 2024 as the country's 37th domestically developed new medicine. Since its commercial launch in October 2024, the product has recorded prescription growth in the Korean market, while the company has continued to expand its global development and commercial partnerships.

According to the companies, the agreement is intended to support the manufacturing and quality requirements needed for JAQBO's planned U.S. clinical development and strengthen its readiness for entry into the U.S. market.

For Bora Pharmaceuticals, the collaboration further expands its contract development and manufacturing organisation (CDMO) business and supports its strategy of providing manufacturing services that help pharmaceutical and biotechnology companies advance product development and commercialisation.

 

Source: bora-corp.com

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