On Mar. 6, 2026, Sumitomo Pharma announce it has obtained conditional and time‑limited approval in Japan for the manufacturing and marketing authorization of the allogeneic iPS cell‑derived dopaminergic neural progenitor cell product AMCHEPRY® for the indication of the improvement of motor symptoms in patients with Parkinson’s disease who have an inadequate response to existing pharmacological therapies, including levodopa‑containing products.

The Product is the world’s first iPS cell‑derived regenerative medicine. Based on the data from an investigator‑initiated clinical study conducted by Kyoto University Hospital, Sumitomo Pharma submitted its an application for manufacturing and marketing authorization on August 5, 2025, and has now obtained the conditional and time‑limited approval.

Following the National Health Insurance price listing, Sumitomo Pharma will be responsible for marketing of the Product, and S‑RACMO Co. will be responsible for manufacturing. Sumitomo Pharma will conduct a post‑marketing clinical study and a post-marketing surveillance to obtain full approval within the designated period.

Sumitomo Pharma and RACTHERA aim to provide patients with Parkinson’s disease with a new treatment option that differs from conventional pharmacotherapies and to further contribute to advances in the treatment of Parkinson’s disease.

The Product contains non‑frozen dopaminergic neural progenitor cells manufactured through differentiation of allogeneic iPS cells. Dopamine is a neurotransmitter, which is produced in dopaminergic neurons. Dopaminergic neural progenitor cells are cells that have not yet differentiated into dopaminergic neurons. The Product received the SAKIGAKE Designation for regenerative medical products in February 2017 and was designated as an orphan regenerative medical product in December 2025 from the Ministry of Health, Labour and Welfare.