BORA PHARMACEUTICALS LTD

Bora Pharmaceuticals and Onconic Therapeutics have entered into a manufacturing agreement to support the U.S. clinical development of JAQBO tablets, a potassium-competitive acid blocker treatment for gastroesophageal reflux disease. Under the agreement, Bora's newest oral solid dose facility in Maple Grove, Minnesota, will manufacture and package clinical trial drug product, and also support quality control, stability testing, and preparation of chemistry, manufacturing, and controls documentation for Onconic's planned U.S. Phase 3 clinical trial. JAQBO was independently developed by Onconic and approved in Korea in April 2024 as the country's 37th domestically developed new drug, and has shown strong prescription growth since its launch in October 2024. The partnership builds on Bora's global contract development and manufacturing organization momentum and its focus on helping partners accelerate launches and scale supply.

Bora Pharmaceuticals has completed its acquisition of MacroGenics' GMP manufacturing operations, including a biologics drug substance facility in Rockville, Maryland and an associated warehousing center in Frederick, Maryland, for total consideration of US $122.5 million. The transaction, executed through Bora's wholly owned subsidiary Bora Biologics USA, LLC, establishes a 20,000-liter single-use bioreactor drug substance manufacturing platform across two active US sites in Rockville and San Diego, California, along with a development facility in Zhubei, Taiwan. Upon closing, Bora signed a long-term CDMO Service Agreement with MacroGenics. Bora Biologics now supports more than four active commercial programs, has completed over 120 GMP batches, and supplies multiple global markets including the US, EU, Japan, Canada, and the UK. The combined platform has undergone five FDA inspections with clean results and one PMDA review in 2025, and has supported more than 33 biologics and 15 biosimilars.