News
Sumitomo Pharma bags world-first go-ahead for iPS cell therapy to treat Parkinson’s disease
The conditional, time-limited approval comes through a joint effort with RACTHERA, a joint venture in which Sumitomo Chemical holds a 66.6% stake and Sumitomo Pharma holds 33.4%
- By IPP Bureau
| March 10, 2026
Sumitomo Pharma, a subsidiary of Sumitomo Chemical, has announced that it has received manufacturing and marketing authorization in Japan for its allogeneic iPS cell‑derived dopaminergic neural progenitor cell product, AMCHEPRY, marking the world’s first-ever approval of a regenerative medicine and cell therapy product derived from iPS cells.
The conditional, time-limited approval comes through a joint effort with RACTHERA, a joint venture in which Sumitomo Chemical holds a 66.6% stake and Sumitomo Pharma holds 33.4%. “This approval is a significant milestone in our longstanding initiatives in stem cell research and the practical implementation of regenerative and cellular therapies,” the company said.
Sumitomo Chemical, which owns 51.76% of Sumitomo Pharma, highlighted that regenerative medicine and cell therapy form a core pillar of its medium- to long-term growth strategy in healthcare. “The Product is expected to become a blockbuster product that will generate over 100 billion yen in sales in the 2030s,” the company said.
The manufacturing of AMCHEPRY will be handled by S-RACMO,ba joint venture experienced in commercial production of regenerative therapies. “S-RACMO already plays a pioneering role in the manufacturing of a wide variety of regenerative and cellular therapies,” the release noted.
Sumitomo Chemical, Sumitomo Pharma, RACTHERA, and S-RACMO will continue collaborating to expand the regenerative and cellular therapy business. “We will deliver new innovative treatments to patients as solutions in the healthcare field, including advanced medical care, and thereby contribute to solving societal issues,” the companies said.
