PharmaEngine's US Plant Secures First Asian New Drug Client

PharmaEngine announced a significant milestone as its manufacturing facility in Maple Grove, Minnesota, welcomes its first Asian new drug client: Onconic Therapeutics, a subsidiary of South Korea's Firstpharmaceutical. The two companies have signed a manufacturing cooperation agreement for JAQBO, an investigational potassium-competitive acid blocker (P-CAB) tablet developed by Onconic for the treatment of gastroesophageal reflux disease (GERD). This partnership is set to bolster the US clinical development of JAQBO and prepare for its subsequent commercial production. Onconic Therapeutics focuses on developing new drugs for cancer and gastrointestinal diseases, with projections to achieve profitability in 2025. Under the agreement, PharmaEngine's Maple Grove plant will provide crucial services for JAQBO, including quality control, stability testing, and the preparation of Chemistry, Manufacturing, and Controls (CMC) documentation necessary for Onconic's planned US Phase III clinical trials. These efforts aim to establish manufacturing, quality, and stability data that meet US regulatory requirements, laying a solid foundation for future clinical trials and commercial manufacturing. JAQBO, developed independently by Onconic Therapeutics, received marketing approval in South Korea in April 2024, becoming the 37th independently developed new drug from the country. It officially launched in South Korea in October 2024 and has seen continuous growth in prescription volume. Onconic has also entered into commercialization agreements in several international markets, accelerating its global expansion. PharmaEngine highlighted that its Maple Grove facility possesses large-scale oral solid dosage form development and commercial manufacturing capabilities. This new project, involving an Asian innovative drug company's US clinical program, signifies an extension of PharmaEngine's Contract Development and Manufacturing Organization (CDMO) services. These services are evolving from existing commercial manufacturing and long-term contracts with international pharmaceutical companies to encompass the development needs of Asian innovative drugs targeting the US market. PharmaEngine plans to continue integrating its North American and Asian manufacturing networks to offer comprehensive one-stop services, from clinical development and regulatory preparation to commercial-scale production, thereby strengthening its competitive edge as a global pharmaceutical service platform.