Items stated in the management plan
FormulatedFollowing the capital and business alliance with Senju Pharmaceutical Co., Ltd., the policy was changed to prioritize development in Japan. A development plan has been adopted that aims to obtain approval while making maximum use of development data accumulated overseas to date and containing the development costs and risks required before commercialization.
| Item | Details |
|---|---|
| Plan name | Domestic Development Plan for the Glaucoma Treatment H-1337 |
| Progress against the plan | Formulated |
| Plan assumptions | Clinical trials must be conducted in accordance with Japanese regulatory requirements, Make maximum use of development data accumulated overseas to date |
| Key initiatives | Conduct a clinical trial consultation with the PMDA during fiscal 2026, Conduct a small-scale dose-confirmation study in Asians, primarily Japanese, in 2027, Start a domestic Phase III clinical trial in 2029, Begin development in Japan with a small-scale dose-confirmation study in Asians, primarily Japanese, and then move promptly to a domestic Phase III clinical trial, Continue considering commercialization, including future clinical development and out-licensing |
| Reason for revision or withdrawal | Following the capital and business alliance with Senju Pharmaceutical Co., Ltd., the policy was changed to prioritize development in Japan. A development plan has been adopted that aims to obtain approval while making maximum use of development data accumulated overseas to date and containing the development costs and risks required before commercialization. |
| Risks identified | Conducting clinical trials in accordance with Japanese regulatory requirements, Development costs, Development risks |
| Date of board resolution | 3 September 2026 |
| Publication date | 3 September 2026 |
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The reasons the company gives
The company's own explanation, not something inferred from the numbers.The policy was changed to prioritize development in Japan following the capital and business alliance with Senju Pharmaceutical Co., Ltd. The aim is to obtain approval while making maximum use of development data accumulated overseas and containing the development costs and risks required before commercialization.