Agreements reached under this partnership
Business alliance- 1
Compilation of basic information on the product
- 2
Feasibility assessment of the regulatory strategy
- 3
Quality (CMC) assessment
- 4
Clinical package assessment
- 5
Assessment of GMP, supply and legal risks
- 6
Presentation of the recommended application strategy
These are items that the documents state the two companies will work on. The lines above and below represent arrangements between the two companies.
The impact on the Company's results for the fiscal year ending March 2026 is expected to be immaterial. The impact on results for the fiscal year ending March 2027 is also currently judged to be immaterial. The impact on results for the fiscal year ending March 2028 and thereafter is currently under review.
| Item | Details |
|---|---|
| Name of alliance partner | 株式会社シーエムプラス |
| Alliance partner's business activities | Consulting services relating to manufacturing quality and regulatory applications for pharmaceuticals, medical devices, regenerative medicine products and other products |
| Alliance partner's location | Nishi-ku, Yokohama, Kanagawa |
| Alliance partner's capital | ¥66 million |
| Alliance partner's net sales | Not disclosed (pursuant to a confidentiality agreement with the counterparty) |
| Alliance partner's operating income | Not disclosed (pursuant to a confidentiality agreement with the counterparty) |
| Type of alliance | Business alliance |
| Details of the alliance | Compilation of basic information on the product, Feasibility assessment of the regulatory strategy, Quality (CMC) assessment, Clinical package assessment, Assessment of GMP, supply and legal risks, Presentation of the recommended application strategy |
| Date of board resolution | Not disclosed (resolution date of the management meeting of subsidiary シンクスヘルスケア: 27 March 2026) |
| Contract Date | April 2026 (scheduled) |
| Alliance start date | July 2026 (scheduled) |
| Impact on Business Performance | The impact on the Company's results for the fiscal year ending March 2026 is expected to be immaterial. The impact on results for the fiscal year ending March 2027 is also currently judged to be immaterial. The impact on results for the fiscal year ending March 2028 and thereafter is currently under review. |
Items this document does not state (11)
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.The purpose is to evaluate the regulatory strategy, quality (CMC), clinical package, GMP and supply structure, and legal risks in preparation for an application for marketing authorization in Japan, thereby improving the accuracy of the application preparations and accelerating the evaluation process.