Announced details
Treatment of achondroplasia (ACH), drug discovery support for pharmaceutical companies, and drug delivery
In the Phase 2 clinical trial, the 11 participants who completed dosing achieved an average height increase of +1.4 cm from baseline (p=0.04). In the Phase 3 clinical trial, an average annual height velocity of at least +3.0 cm is expected.
12 participants in the Phase 2 clinical trial and 16 participants in the Phase 3 clinical trial
The Company is advancing discussions with pharmaceutical companies regarding the licensing and partnership of umedaptanib pegol. It has already monetized the drug discovery support business through multiple companies.
Orphan drug designation
6F, Shiroganedai Usui Building, 3-16-13 Shiroganedai, Minato-ku, Tokyo
The Company aims to achieve sustainable business revenue. The drug discovery support business has already been monetized through multiple companies. The specific impact on business performance is Not disclosed.
The company does not address Contract Value / Offering price.
Discussions with PMDA (Japan's Pharmaceuticals and Medical Devices Agency)
| Item | Details |
|---|---|
| Names of Products / Services Covered | umedaptanib pegol (anti-FGF2 aptamer), Drug discovery support business (drug delivery technology using lipid nanoparticles (LNPs) (DDS)) |
| Relationship with the Company | The Company is advancing discussions with pharmaceutical companies regarding the licensing and partnership of umedaptanib pegol. It has already monetized the drug discovery support business through multiple companies. |
| Launch date | The Phase 3 clinical trial commenced in spring 2026 (actual). The drug discovery support business was launched in the current fiscal year (no specific timing disclosed). |
| Applicable area | Treatment of achondroplasia (ACH), drug discovery support for pharmaceutical companies, and drug delivery |
| Award/certification name | Orphan drug designation |
| Location | 6F, Shiroganedai Usui Building, 3-16-13 Shiroganedai, Minato-ku, Tokyo |
| Location scale | 25 employees (14 PhDs) |
| Quantitative Effects | In the Phase 2 clinical trial, the 11 participants who completed dosing achieved an average height increase of +1.4 cm from baseline (p=0.04). In the Phase 3 clinical trial, an average annual height velocity of at least +3.0 cm is expected. |
| Usage history | 12 participants in the Phase 2 clinical trial and 16 participants in the Phase 3 clinical trial |
| Impact on Business Performance | The Company aims to achieve sustainable business revenue. The drug discovery support business has already been monetized through multiple companies. The specific impact on business performance is Not disclosed. |
| Source | Discussions with PMDA (Japan's Pharmaceuticals and Medical Devices Agency) |
Items this document does not state (7)
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.To achieve sustainable business revenue, strengthen the Board of Directors’ oversight function, accelerate decision-making by delegating authority for execution, and deliver new drugs to patients at an early stage.