FJ3, API Manufacturing Building for Small Molecule and Macrocyclic Peptide Drugs at the Fujieda Plant, Receives the 2026 Facility of the Year Awards from ISPE in the Honorable Mention Category

• Third award following recognition of the Fujieda Plant’s FJ2 in 2023 and Ukima Plant’s UK4 in 2024
• Award recognizes the outstanding technology that enables the flexible and efficient production of macrocyclic peptide APIs, a new drug discovery modality, and conventional small molecule APIs in shared facilities

TOKYO, April 22, 2026 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that FJ3, API manufacturing building for small molecule and macrocyclic peptide drugs at the Fujieda Plant (Fujieda-shi, Shizuoka) of Chugai Pharma Manufacturing Co., Ltd. (Head office: Tokyo, President: Kenji Kamada), a manufacturing group company of Chugai, has received the 2026 Facility of the Year Awards from the International Society for Pharmaceutical Engineering (ISPE) in the Honorable Mention category. This marks the third time for Chugai Group facilities to receive the annual award, following the recognition of the Fujieda Plant’s API manufacturing building for small molecule and macrocyclic peptide drugs “FJ2,” in the Innovation category in 2023, and the Ukima Plant’s bio drug substance manufacturing building “UK4,” in the Social Impact category in 2024.

The award in the Honorable Mention category recognized FJ3 for its facility design featuring Dual Manufacturing Capability, which enables the flexible and efficient production of macrocyclic peptide APIs, a new drug discovery modality, using Chugai’s proprietary pharmaceutical technology platform, as well as conventional small molecule APIs, within shared facilities. The facility was also recognized for its contribution to the establishment of a manufacturing system capable of meeting global demand. The award in the Honorable Mention category also recognized FJ3 for establishing a manufacturing facility that reduces operator workload and human error through advanced automation and digitalization, while continuously maintaining high productivity via the parallel operation of multiple lines. FJ3 also ensures a high level of safety not only during normal operations but also in emergency situations through the introduction of world-leading containment technologies with an airborne concentration of 0.03 µg/m³ or less, enabling the safe handling of larger volumes of highly potent substances than FJ2, as well as a building design that minimizes the impact on the surrounding environment in the event of an explosion, and a base-isolated structure.

Macrocyclic peptides, which Chugai is focusing on as its third modality following small molecules and antibodies, are expected to serve as a new drug discovery modality for targets that have been difficult to address with conventional modalities, and have been created through its proprietary macrocyclic peptide drug discovery platform technology, SnipeTide^®. Chugai’s macrocyclic peptides are complex cyclic peptides composed of many non-natural amino acids. Compared with small molecules, they require a greater number of manufacturing steps, and purification of intermediates and APIs is more challenging, requiring advanced production technologies and quality control. In addition, because they are highly potent substances, API manufacturing requires facilities and technologies with extremely high containment capability.

FJ3 is a manufacturing facility that addresses these technical challenges and supports the high-quality and stable supply of APIs for small molecule and macrocyclic peptide drugs from late-stage development to commercial production. In collaboration with existing facilities at the same Fujieda Plant (FJ1 and FJ2), an integrated in-house supply system has been established that covers early clinical development through early commercial production, enabling the flexible and rapid supply of investigational drugs and contributing to faster launches of new products. Chugai will continue to pursue advanced production technologies and strengthen its stable supply infrastructure to deliver innovative medicines to patients as quickly as possible.

[Reference]

Completion of “FJ3,” API Manufacturing Building for Late-Stage Development and Early Production at the Fujieda Plant (News release by Chugai Pharma Manufacturing issued on March 4, 2025)
https://cpmc.chugai-pharm.co.jp/news/detail/20250304_01.html (Japanese only)

Construction of API Manufacturing Building for Late Stage Clinical Development and Early Commercial Production of Small and Mid-Size Molecule Drugs (News release by Chugai issued on July 26, 2021)
https://www.chugai-pharm.co.jp/english/news/detail/20210726160001_847.html

About ISPE and FOYA

ISPE (International Society for Pharmaceutical Engineering) is a non-profit organization established in the United States in 1980, with participation from specialist engineers involved in healthcare product manufacturing, regulatory authorities, universities, research institutions, and students from 90 countries around the world. FOYA (Facility of the Year Awards) is an annual award program organized by ISPE. Awards are presented in six categories - Innovation, Operations, Supply Chain, Pharma 4.0, Social Impact, Honorable Mention - in recognition of innovation and creativity in the pharmaceutical and biotechnology manufacturing industries. Additional information is available at https://ispe.org/facility-year-awards.

About FJ3

FJ3 is an API manufacturing building for small molecule and macrocyclic peptide drugs at the Fujieda Plant (Fujieda-shi, Shizuoka), responsible for manufacturing investigational drugs for late-stage development through early commercial production. Construction began in March 2022, and the facility was completed in November 2024. The facility is equipped with advanced containment technologies capable of supporting large-scale synthesis of highly potent APIs as well as automation of manufacturing processes, pursuing labor savings and improved productivity while also taking environmental impact reduction into consideration.

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