Cuorips Inc.
Status of Manufacturing and Marketing Approval Review for Human (Allogeneic) iPS Cell-Derived Cardiomyocyte Sheets
The Pharmaceuticals and Medical Devices Agency panel has determined that the human (allogeneic) iPS cell-derived cardiomyocyte sheet IPSOC-1 can be approved with conditions and time limitations, and formal approval by the Ministry of Health, Labour and Welfare is expected.
Key Figures
- Date of Manufacturing and Marketing Approval Review Decision: 2026-02-19
- Product Name: Human (Allogeneic) iPS Cell-Derived Cardiomyocyte Sheet (IPSOC-1)
- Designation Date as Regenerative Medicine Product for Rare Diseases: 2025-10-24
AI要約
Status of Manufacturing and Marketing Approval Review
QUOLIPS, Inc. received a determination from the Pharmaceuticals and Medical Devices Agency Regenerative Medicine Products and Biologics Technology Subcommittee on 2026-02-19 that the human (allogeneic) iPS cell-derived cardiomyocyte sheet (IPSOC-1), applied for approval in April 2025, can be approved with attached conditions and a time limit. This product is intended to treat severe heart failure caused by ischemic cardiomyopathy, targeting patients for whom standard treatments are insufficient.
Future Outlook and Impact
Based on this panel decision, formal manufacturing and marketing approval with conditions and a time limit is expected from the Ministry of Health, Labour and Welfare. While the impact on the consolidated financial results for this fiscal year is considered minimal, any significant developments will be disclosed promptly. IPSOC-1 was designated as a regenerative medicine product for rare diseases on 2025-10-24.
