Kyowa Kirin Completed Construction of a New Biopharmaceutical DS Manufacturing Facility at Takasaki Plant -Acceleration of development through the establishment of an innovative global manufacturing structure-

Tokyo, Japan, April 11, 2025 -- Kyowa Kirin Co., Ltd. (TSE: 4151, President and COO: Abdul Mullick, “Kyowa Kirin”) announces that it has completed the construction of a new DS (Drug Substance) manufacturing Facility (HB7 building) at its biopharmaceutical manufacturing site- Takasaki Plant (Takasaki city, Gunma Prefecture, Plant Manager: Naoki Matsunaga).

HB7 building is designed and built to manufacture drug substance (DS) for biopharmaceuticals utilizing Kyowa Kirin’s innovative antibody technology and protein engineering, and it will be equipped with both GMP compliant manufacturing facility for the investigational drugs in early phase development, and pilot facility for process development. In addition to having the same manufacturing equipment, these GMP and pilot facilities also utilize single-use technology, which reduces the risk of cross-contamination between products without the need to spend time of cleaning verification or validation. This is expected to lead to an early supply of investigational drugs and accelerate development. In addition, the building is also designed with space for future expansion, to enable the smooth introduction of next-generation manufacturing technologies such as continuous production, as well as new challenges including automation and digitization, with the aim of realizing a smart factory in the future.

In addition, a training facility for the manufacturing and quality control of biopharmaceuticals has been set up in HB7 building. The unique feature of this training facility is that it has equipment that allows trainees to perform the same operations and simulations as in the actual manufacturing process in Kyowa Kirin. Realizing the pharmaceutical industry in Japan is lacking experienced engineers in biopharmaceutical manufacturing, Kyowa Kirin has established the Human Resource Development Office at Takasaki Plant since 2022 as a specialized organization for human resource development to deal with this situation. Utilizing HB7 building, it is our aim to further enhance our training program, which combines practical and classroom-based learning, and to continue to develop outstanding talents.

“I am extremely pleased that the construction of HB7 building is now completed in Takasaki Plant,” said Toshiyuki Kurata, MBA, Managing Executive Officer, Chief Supply Chain Officer (CSCO) of Kyowa Kirin. “In June 2024, we also announced to build a biopharmaceutical plant in Sanford, North Carolina, USA, and the construction is currently underway. By establishing a global manufacturing structure that utilizes Takasaki Plant, including HB7 building, and the plant in Sanford, we aim to further accelerate development by manufacturing DS in-house, from early to late-stage development and the initial stages of market launch. We strive to provide life-changing values to patients in a speedy way through the circulation of global-level technology and talent development in the manufacturing of biopharmaceuticals.”

A completion ceremony was held to mark the completion of the building. Naritaka Nakaishi, Director-General National Healthcare Policy Secretariat, Cabinet Office, Government of Japan, delivered a speech, in which he highlighted the importance of both the public and private sectors working together to develop talents to deliver biopharmaceuticals originated from Japan across the world, and expressed his expectations for Kyowa Kirin’s initiative to develop human resources in this field. Also, Takeshi Shukunobe, CEO of PPeCC,Inc. a patient advocacy group which aims to deliver the voices of people living with diseases to the medical community and create a cycle in which medicine and support that incorporate those voices are born, kindly participated in the event. Mr. Shukunobe expressed his strong belief that although there are not enough opportunities for patients and pharmaceutical company employees to communicate, they are mutually connected. The ceremony was a valuable opportunity for employees to reaffirm the importance of stable supplies of high-quality pharmaceuticals.

The Kyowa Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.