Bora Pharmaceuticals and Onconic Therapeutics have signed a manufacturing agreement to support the U.S. clinical development of JAQBO Tablets. The collaboration will help advance JAQBO, a potassium-competitive acid blocker (P-CAB) treatment for gastroesophageal reflux disease (GERD).
Manufacturing and packaging of the trial drug products for JAQBO tablets will be done by Bora Pharmaceuticals. The company will assist Onconic Therapeutics as it plans to conduct its U.S. Phase 3 clinical trial.
The contract also covers quality control, stability studies, and assistance in Chemistry, Manufacturing, and Controls documentation. The company will offer these services using its newest Oral Solid Dosage (OSD) manufacturing facility located in Maple Grove, Minnesota.
“For companies preparing for U.S. clinical development and commercialization, the right manufacturing partner can make a meaningful difference in how quickly a program moves forward,” said Bobby Sheng, Chairman of Bora Group and CEO of Bora. “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 and Onconic Advance JAQBO Development for Global Expansion
GERD is prevalent among almost 20% of the U.S. population. As a result, the need for more sophisticated acid inhibition therapies remains consistent. P-CAB therapy offers a strong treatment option because it delivers rapid and long-lasting acid inhibition. Onconic Therapeutics developed JAQBO independently. Korean regulators approved the drug as the country’s 37th indigenous drug in April 2024.
In its commercial release in October 2024, JAQBO has made impressive gains in prescriptions in Korea. Moreover, the therapy has extended its development and commercialization deals worldwide.
“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,” said a representative from Onconic Therapeutics. “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.”
In addition to that, this collaboration demonstrates the continuous growth of Bora Pharmaceuticals as a global CDMO. It is involved in providing assistance to its pharmaceutical and biotech partners in the form of better development times. Faster launches and greater supply capabilities. Through this collaboration, both companies intend to ensure the success of JAQBO tablets in the market.
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News Source: Businesswire.com
