Worth reading
29Immaterial
0–100. This measures how worthwhile something is to read, not how good or bad the company is.Direction
Neutral
Direction inferred from the company’s description.Scale
—
Displayed only when the document provides numerical figures.Wording
Conditional
How definitive the wording is.Items stated in the management plan
FormulatedKey initiatives
01File an application for marketing approval for the product in Japan by the end of 2026, using the results of clinical trials conducted overseas as the primary basis.
02Obtain approval and launch the product by the end of 2027.
03Conduct a clinical trial in Japanese DMD patients to evaluate pharmacokinetics and safety, separately from the application for marketing approval for the product.
Plan assumptionsThe results of clinical trials conducted overseas will serve as the primary basis., The product has already been approved in multiple countries, including the United States, the EU and the United Kingdom.
Non-financial targetsIndicator name Application for marketing approval in Japan / Target value By the end of 2026 / Timing By the end of 2026, Indicator name Approval and product launch / Target value By the end of 2027 / Timing By the end of 2027
Size of the Target MarketTarget patient population Approximately 3,500 DMD patients in Japan / Incidence at birth Worldwide incidence at birth: approximately 1 in 5,050 boys / Source Mitsuru Kawai, “How Many Duchenne Muscular Dystrophy Patients Are There in Japan?”, Crisafulli et al., Global epidemiology of Duchenne muscular dystrophy
Risks identified by the company
Known or unknown risks and uncertainties
The outcome or progress of development may differ materially from the information provided.
| Item | Details |
|---|---|
| Plan name | Domestic development plan |
| Plan period | 2026–2027 |
| Progress against the plan | Formulated |
| Non-financial targets | Indicator name Application for marketing approval in Japan / Target value By the end of 2026 / Timing By the end of 2026, Indicator name Approval and product launch / Target value By the end of 2027 / Timing By the end of 2027 |
| Plan assumptions | The results of clinical trials conducted overseas will serve as the primary basis., The product has already been approved in multiple countries, including the United States, the EU and the United Kingdom. |
| Key initiatives | File an application for marketing approval for the product in Japan by the end of 2026, using the results of clinical trials conducted overseas as the primary basis., Obtain approval and launch the product by the end of 2027., Conduct a clinical trial in Japanese DMD patients to evaluate pharmacokinetics and safety, separately from the application for marketing approval for the product. |
| Size of the Target Market | Target patient population Approximately 3,500 DMD patients in Japan / Incidence at birth Worldwide incidence at birth: approximately 1 in 5,050 boys / Source Mitsuru Kawai, “How Many Duchenne Muscular Dystrophy Patients Are There in Japan?”, Crisafulli et al., Global epidemiology of Duchenne muscular dystrophy |
| Risks identified | Known or unknown risks and uncertainties, The outcome or progress of development may differ materially from the information provided. |
| Publication date | 15 July 2026 |
Items this document does not state (16)
Sales TargetOperating profit targetOperating profit margin targetNet income targetROE targetROIC targetPayout ratio / DOE policyTreasury share acquisition policyCost of capitalSelf-assessment of PBR and share priceTotal investment planInvestment amount by sectorSegment targetResults under the previous planReason for revision or withdrawalDate of board resolution
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.Based on the results of face-to-face consultations with the PMDA, the company expects to be able to deliver the product to Japanese DMD patients sooner because the results of clinical trials conducted overseas can be used as the primary basis for the application.
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