Announced details
Treatment of severe heart failure caused by ischemic cardiomyopathy inadequately controlled by standard drug therapy. The product is intended for patients who have undergone coronary artery bypass grafting (CABG) and have a left ventricular ejection fraction (LVEF) of 40% or less at rest.
The Ministry of Health, Labour and Welfare designated the HS-001 being developed by the Company as an eligible product.
The Ministry of Health, Labour and Welfare, which designates products as regenerative medical products for rare diseases. Other information, including its location, representative, capital and year of establishment, was not disclosed.
Designation as a product covered by the regenerative medical products for rare diseases program
Ministry of Health, Labour and Welfare
Designation date: 9 November 2026. The program description states that the re-examination period may be extended by up to 10 years.
No revision has been made to the earnings forecast for the fiscal year ending December 2026.
The company does not address Contract Value / Offering price.
| Item | Details |
|---|---|
| Names of Products / Services Covered | Allogeneic iPS cell-derived cardiac muscle spheroid “HS-001” (name: remumiocel) |
| Counterparty | Ministry of Health, Labour and Welfare |
| Counterparty overview | The Ministry of Health, Labour and Welfare, which designates products as regenerative medical products for rare diseases. Other information, including its location, representative, capital and year of establishment, was not disclosed. |
| Relationship with the Company | The Ministry of Health, Labour and Welfare designated the HS-001 being developed by the Company as an eligible product. |
| Applicable area | Treatment of severe heart failure caused by ischemic cardiomyopathy inadequately controlled by standard drug therapy. The product is intended for patients who have undergone coronary artery bypass grafting (CABG) and have a left ventricular ejection fraction (LVEF) of 40% or less at rest. |
| Award/certification name | Designation as a product covered by the regenerative medical products for rare diseases program |
| Awarding / certifying body | Ministry of Health, Labour and Welfare |
| Registration number and expiry date | Designation date: 9 November 2026. The program description states that the re-examination period may be extended by up to 10 years. |
| Impact on Business Performance | No revision has been made to the earnings forecast for the fiscal year ending December 2026. |
Items this document does not state (9)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.Because it met the criteria relating to the number of eligible patients, unmet medical need and development potential.