Cuorips Inc.
Acquisition of Conditional and Time-limited Manufacturing and Marketing Approval for Human (Allogeneic) iPS Cell-Derived Cardiomyocyte Sheet
Quolips, Inc. announced that it has obtained conditional and time-limited manufacturing and marketing approval from the Ministry of Health, Labour and Welfare for the human (allogeneic) iPS cell-derived cardiomyocyte sheet "Reheart" on March 6, 2026.
Key Figures
- Approval Date: March 6, 2026 (Conditional and time-limited manufacturing and marketing approval obtained from Ministry of Health, Labour and Welfare)
- Target Disease: Severe heart failure due to ischemic cardiomyopathy (patients with insufficient effect from standard treatments)
- Planned Sales Launch: Around Autumn 2026 (Domestic)
AI要約
Overview of Product Approval
Quolips, Inc. has obtained conditional and time-limited manufacturing and marketing approval from the Ministry of Health, Labour and Welfare on March 6, 2026, for the human (allogeneic) iPS cell-derived cardiomyocyte sheet "Reheart." The target patients are those with severe heart failure due to ischemic cardiomyopathy who have insufficient effects from standard treatments, including drug therapy and invasive therapies. This product is the first iPS cell-based regenerative medical product originating in Japan and the world, expected to promote myocardial repair and functional improvement.
Future Outlook
Following approval, Quolips will promptly apply for insurance listing, and after insurance coverage, commence post-marketing surveillance targeting all 75 cases as planned. Domestic sales are scheduled for around autumn 2026, with accelerated overseas expansion anticipated. This development will not affect consolidated results in the current period but is expected to contribute to medium- to long-term corporate value enhancement.
