Establishment of Manufacturing and Marketing Licensing, Sales and Distribution, and Information-Provision Systems
First written in FY2023. 7 of 9 entries say "Advanced", first in FY2025. Latest entry: 2026-08-13.
0 other companies' latest entry also says "Advanced".
- FY2026AdvancedAnnual report
「We will establish a logistics system for distribution in preparation for commencing sales after reimbursement listing and coverage under public health insurance.」
The company moved from obtaining the marketing and manufacturing licenses to preparing for reimbursement listing, the sales launch, post-marketing surveillance and the supply system. - FY2025AdvancedAnnual report
「With a view to obtaining marketing approval for the human iPS cell-derived cardiomyocyte sheet, we obtained a license to market regenerative medical products in August 2024 and a license to manufacture regenerative medical products in April 2025. We plan to begin commercial production after obtaining marketing approval.」
The company obtained the marketing and manufacturing licenses, advancing the regulatory infrastructure required for commercial production. Post-marketing surveillance, sales and distribution systems, and securing customers remained under development. - FY2024RestatedAnnual report
「This includes preparations for applying for a license to market regenerative medical products, preparations for the manufacturing and marketing system required for commercial production of the human iPS cell-derived cardiomyocyte sheet, securing sales personnel to sell and distribute manufactured products to medical institutions, and establishing a system for conducting efficacy and safety surveillance after the start of sales.」
The company continued preparing the commercial system, including the marketing-authorization and manufacturing licenses, the three-person responsible-person system, sales personnel, logistics and post-marketing surveillance. - FY2023First statedAnnual report
「This includes preparations for applying for a license to market regenerative medical products, preparations for the manufacturing and marketing system required for commercial production of the human iPS cell-derived cardiomyocyte sheet, securing sales personnel to sell and distribute manufactured products to medical institutions, and establishing a system for conducting efficacy and safety surveillance after the start of sales.」
This includes the three-person responsible-person system, GQP and GVP, GCTP, core business systems, sales personnel, information provision to medical institutions, and the post-marketing surveillance system.