AGC Biologics S.p.A. (headquartered in Milan, Italy; hereinafter “AGC Biologics”), the biopharmaceutical CDMO^*1 subsidiary of AGC Inc. (headquartered in Tokyo; President: Yoshinori Hirai), announces that the ex vivo gene therapy Waskyra™, which it contract-manufactured, has received marketing authorization from the U.S. Food and Drug Administration (FDA) and the European Commission. Developed by Fondazione Telethon^*2, an Italian government-recognized non-profit biomedical research organization, Waskyra™ is indicated for Wiskott-Aldrich syndrome, a rare immune disorder. This approval enables patients to access a new treatment option.

For this approval, AGC Biologics leveraged its global top-class experience in process development and contract manufacturing of gene and cell therapies^*3, providing comprehensive support for lentiviral vector^*4 production, patient-specific genetically modified cell manufacturing, and regulatory compliance, assisting with regulatory filings at every step. AGC Biologics will continue to provide support toward commercial manufacturing.

AGC Group’s medium-term management plan, AGC plus-2026, defines three social values. Among them, “Well-being” focuses on contributing to safe, secure, and healthy living by ensuring a stable supply of essential products and services for daily life and healthcare. Through its Life Science business, AGC continues to deliver globally unified, high-quality CDMO services for pharmaceuticals and agrochemicals, maximizing synergies across sites to benefit society.

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