Announcement on the Submission of the Application of Manufacturing and Marketing Authorization for Allogeneic iPS Cell-Derived dopaminergic neural progenitor cells in Japan
Sumitomo Pharma Co., Ltd. (Head Office: Osaka, Japan; “Sumitomo Pharma”) and RACTHERA
Co., Ltd. (Head Office: Chuo-ku, Tokyo, Japan;, “RACTHERA”) hereby announce that on August
5, 2025, they have submitted an application of manufacturing and marketing authorization for
allogeneic iPS cell-derived dopaminergic neural progenitor cells (INN: “raguneprocel”, “the
Product”) for indication of the improvement of motor functions during the off-time period of patients
with advanced Parkinson’s disease. The applicant for the authorization is Sumitomo Pharma.
This submission was based on the data from the investigator-initiated trial conducted by Kyoto
University Hospital, and its results were published in the journal Nature* in April 2025. The Product
is to be manufactured by S-RACMO Co., Ltd. (Head Office: Suita, Osaka, Japan) and marketed
by Sumitomo Pharma. The Product has been designated by the Ministry of Health, Labour and
Welfare as a product for priority review under the SAKIGAKE Designation System.
Sumitomo Pharma and RACTHERA will strive to provide new medical value that cannot be
expected from existing treatments, and will further contribute to the treatment of Parkinson’s
disease.
*Phase I/II trial of iPS-cell-derived dopaminergic cells for Parkinson’s disease, Nature
https://doi.org/10.1038/s41586-025-08700-0
(Reference)
Allogeneic iPS cell-derived dopaminergic neural progenitor cells (INN; raguneprocel):
Dopamine is a neurotransmitter, which is produced in the dopamine neurons. Dopaminergic
neural progenitor cells are cells that have not yet differentiated into dopaminergic neurons. The
Product contains non-frozen dopaminergic neural progenitor cells manufactured through
differentiation from iPS cells.
The technology for manufacturing iPS cell-derived dopaminergic neural progenitor cells:
The Product contains the dopaminergic neural progenitor cells differentiated from iPS cells stock
provided by CiRA Foundation based on differentiation and manufacturing technology owned by
Kyoto University and other parties. In addition, the Product, in one of its production steps for
dopaminergic neural progenitor cells, employs a proprietary cell purification technology
discovered by KAN Research Institute, Inc. (currently Kobe Research Laboratories, Eisai Co.,
Ltd.) and owned by Eisai Co., Ltd.
RACTHERA:
RACTHERA is a joint venture between Sumitomo Chemical Co., Ltd. (“Sumitomo Chemical”) and
Sumitomo Pharma. It began operations on February 1, 2025, after inheriting intellectual property
and other assets related to the regenerative medicine and cell therapy business from Sumitomo
Pharma.
S-RACMO:
S-RACMO is a joint venture between Sumitomo Chemical and Sumitomo Pharma, and operates
as a Contract Development and Manufacturing Organization (CDMO) that undertakes the
development of manufacturing processes and the production of regenerative medicine and cell
therapy products.
Contact:
Corporate Communications, Corporate Governance Sumitomo Pharma Co., Ltd.
E-mail: prir@sumitomo-pharma.co.jp
Business Administration Department, RACTHERA Co., Ltd.
E-mail: contact@racthera.co.jp
