Announced details
Acute myeloid leukemia (AML), particularly relapsed or refractory AML
Potential access to benefits such as enhanced opportunities for development consultations with the FDA, waivers or reductions of regulatory submission fees, and market exclusivity after approval
The FDA is the regulatory authority that granted the orphan drug designation. The Company is collaborating with MD Anderson Cancer Center on the development of a triplet combination therapy with azacitidine (AZA) and venetoclax (VEN) for patients with relapsed or refractory AML.
The U.S. Food and Drug Administration is the U.S. pharmaceutical regulatory authority. The University of Texas MD Anderson Cancer Center is collaborating with the Company on the development of a triplet combination therapy for patients with AML; its location, representative, capital, and year of establishment are not provided.
FDA Orphan Drug Designation (ODD)
U.S. Food and Drug Administration (FDA)
No impact on the consolidated 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 | monzosertib（AS-0141）, CDC7 inhibitor |
| Counterparty | U.S. Food and Drug Administration (FDA), The University of Texas MD Anderson Cancer Center |
| Counterparty overview | The U.S. Food and Drug Administration is the U.S. pharmaceutical regulatory authority. The University of Texas MD Anderson Cancer Center is collaborating with the Company on the development of a triplet combination therapy for patients with AML; its location, representative, capital, and year of establishment are not provided. |
| Relationship with the Company | The FDA is the regulatory authority that granted the orphan drug designation. The Company is collaborating with MD Anderson Cancer Center on the development of a triplet combination therapy with azacitidine (AZA) and venetoclax (VEN) for patients with relapsed or refractory AML. |
| Launch date | 21 July 2026 (ODD obtained) |
| Applicable area | Acute myeloid leukemia (AML), particularly relapsed or refractory AML |
| Award/certification name | FDA Orphan Drug Designation (ODD) |
| Awarding / certifying body | U.S. Food and Drug Administration (FDA) |
| Quantitative Effects | Potential access to benefits such as enhanced opportunities for development consultations with the FDA, waivers or reductions of regulatory submission fees, and market exclusivity after approval |
| Impact on Business Performance | No impact on the consolidated earnings forecast for the fiscal year ending December 2026 |
Items this document does not state (8)
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.AML is designated as a rare disease in the United States, and there is a high unmet medical need, including among patients with relapsed or refractory disease. The designation may provide access to benefits such as development consultations with the FDA, waivers or reductions of regulatory submission fees, and market exclusivity after approval.