FDA Selects Kyowa Kirin for PreCheck Pilot Program to Accelerate Manufacturing Timelines and Enhance Supply Chain Resilience

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Strategic collaboration at Sanford, North Carolina facility, currently under construction, to optimize cGMP validation, accelerate time-to-market for complex biologics, and shore up U.S. medicine supply TOKYO and PRINCETON, N.J., June 30, 2026 (GLOBE NEWSWIRE) -- Kyowa Kirin Co., Ltd. (TSE: 4151, Kyowa Kirin), a Japan-based global specialty pharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has selected Kyowa Kirin's Sanford manufacturing facility for the FDA PreCheck Pilot Program. Kyowa Kirin's selection into the program enables the operational acceleration of the state-of-the-art biologics manufacturing facility currently under construction in Sanford, North Carolina. By initiating structured, early-stage regulatory engagement during the facility's build phase, the PreCheck Pilot Program is designed to optimize current Good Manufacturing Practices (cGMP) compliance and validation, accelerate commercial production timelines, and strengthen supply chain resilience for rare disease patients. "Being selected for the FDA PreCheck Pilot Program is a transformative milestone for Kyowa Kirin as a global organization. The Sanford facility marks our first manufacturing footprint in the U.S., and with this program we have the opportunity to build our quality and compliance framework from the ground up in close collaboration with the FDA — establishing a new standard for how we approach manufacturing. As we continue to expand our pipeline of next-generation antibodies and biologics for rare diseases, strengthening our supply chain resilience through the establishment of a U.S.-based manufacturing site is essential to fulfilling our mission of delivering life-changing value to patients around the world." said Toshiyuki Kurata, Chief Supply Chain Officer of Kyowa Kirin. The Sanford facility, which broke ground in late 2024 and is on track to be operational by 2027, will serve as a core U.S. hub for manufacturing innovative biologic therapies, with a strong emphasis on next-generation antibodies for rare and orphan diseases. "One of our primary goals for participating in the FDA PreCheck Pilot Program is the acceleration of the review and approval process to ensure a resilient product supply to patients suffering from rare diseases and other unmet medical needs." said Steve Schaefer, President, Kyowa Kirin North America. "This early e...

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