Development of Regenerative Medicine Products Focused on Autologous Cultured Epidermis, Cartilage and Corneal Epithelium
First written in FY2016. 10 of 20 entries say "Restated". Latest entry: FY2024.
0 other companies' latest entry also says "Restated".
- FY2024RestatedAnnual report
「In March 2023, the company obtained marketing authorization for Jasmine, an autologous cultured epidermis product containing melanocytes, as its fifth regenerative medicine product.」
The company continues to describe its development, manufacturing and sales structure for regenerative medicine products, comprising 5 products: JACE, JACC, Nepic, Ocural and Jasmine. - FY2024-Q1AdvancedAnnual report
「For autologous cultured epidermis containing melanocytes (pigment cells), marketed as Jasmine, which is intended to treat vitiligo for which nonsurgical treatment is ineffective or not indicated, the company obtained marketing authorization on 17 March 2023. It aims to secure national health insurance coverage promptly while expanding its business in dermatology.」
In the development, manufacture and sale of regenerative medicine products, the autologous cultured epidermis Jasmine for the treatment of vitiligo obtained marketing authorization, advancing the product rollout into dermatology. - FY2023-Q2RestatedAnnual report
「In its regenerative medicine products business, the Company manufactures and sells JACE autologous cultured epidermis, JACC autologous cultured cartilage, Nepic autologous cultured corneal epithelium, and Oculal autologous cultured oral mucosal epithelium.」
The company continues to describe its business of manufacturing and selling the regenerative medicine products JACE, JACC, Nepic and Ocural. - FY2023-Q1RestatedAnnual report
「In its regenerative medicine products business, the Company manufactures and sells JACE autologous cultured epidermis, JACC autologous cultured cartilage, Nepic autologous cultured corneal epithelium, and Oculal autologous cultured oral mucosal epithelium.」
The company continues to describe its business of manufacturing and selling the regenerative medicine products JACE, JACC, Nepic and Ocural. - FY2022-Q3AdvancedAnnual report
「Autologous cultured oral mucosal epithelium Ocural is indicated for limbal stem cell deficiency and was listed for national health insurance coverage in December 2021. It is the world's first regenerative medicine product to treat limbal stem cell deficiency using oral mucosal epithelial cells.」
For Ocural, after marketing authorization was obtained, the product reached the stage of national health insurance coverage in December 2021, advancing to the commercialization stage. - FY2022-Q2AdvancedAnnual report
「In September 2021, the plenary session of the Central Social Insurance Medical Council approved the listing of Ocural for national health insurance coverage effective 1 December 2021.」
For autologous cultured oral mucosal epithelium Ocural, after marketing authorization was obtained, its listing for national health insurance coverage effective 1 December 2021 was approved, advancing the product toward commercialization. - FY2022-Q1AdvancedAnnual report
「In June 2021, the company obtained marketing authorization for Ocural, an autologous cultured oral mucosal epithelium product.」
For autologous cultured oral mucosal epithelium Ocural, the company progressed from the preparation stage for an approval application to the stage of obtaining marketing authorization in June 2021. - FY2021-Q2AdvancedAnnual report
「In September 2020, the company filed an application for marketing authorization for autologous cultured oral mucosal epithelium (development name: COMET01), which would be the second regenerative medicine product in the ophthalmology field.」
For autologous cultured oral mucosal epithelium COMET01, the company progressed from the preparation stage for an approval application to the stage of submitting an application for marketing authorization. - FY2020AdvancedAnnual report
「This product obtained marketing authorization in March 2020 for the treatment of limbal stem cell deficiency, became covered by national health insurance in June of the same year, and became the first regenerative medicine product in Japan in the ophthalmology field.」
In the development of regenerative medicine products, the autologous cultured corneal epithelium reached the stages of marketing authorization and national health insurance coverage, expanding the product lineup into ophthalmology. - FY2020-Q3RestatedAnnual report
「As part of its regenerative medicine products business, the company proceeded with the manufacture and sale of JACE, an autologous cultured epidermis product, and JACC, an autologous cultured cartilage product.」
The company continues to manufacture and sell regenerative medicine products, primarily JACE and JACC. - FY2020-Q2RestatedAnnual report
「As part of its regenerative medicine products business, the company proceeded with the manufacture and sale of JACE, an autologous cultured epidermis product, and JACC, an autologous cultured cartilage product.」
The company continues to manufacture and sell JACE and JACC. - FY2019AdvancedAnnual report
「On 31 January 2019, the company obtained approval from the Ministry of Health, Labour and Welfare for a partial-change application to use an artificial collagen membrane instead of the patient's own periosteum when implanting JACC. This made it possible to reduce the invasiveness of JACC and simplify the implantation procedure.」
Regarding JACC, the company obtained approval for a partial-change application aimed at reducing invasiveness and simplifying the implantation procedure, moving from the development stage to the post-approval commercialization stage. - FY2019-Q3RestatedAnnual report
「Meanwhile, the company filed an application in April for approval of a partial change to use an artificial collagen membrane instead of the periosteum. It is proceeding with measures to reduce the invasiveness of JACC and simplify the implantation procedure, but as of the end of December, the review was still ongoing and approval had not been obtained.」
The review of the application for approval of a partial change aimed at reducing the invasiveness of JACC and simplifying the implantation procedure was still ongoing as of the end of December. - FY2019-Q2RestatedAnnual report
「As part of its regenerative medicine products business, the company proceeded with the manufacture and sale of JACE, an autologous cultured epidermis product, and JACC, an autologous cultured cartilage product.」
The company continues to manufacture and sell JACE and JACC. - FY2018AdvancedAnnual report
「April 2018: Submitted a partial-change application for approval of JACC autologous cultured cartilage, aimed at reducing invasiveness and simplifying the transplantation procedure.」
Regarding JACC, the company has reached the stage of filing a partial-change marketing authorization application concerning the previously prepared procedures for simplifying and reducing the invasiveness of implantation. - FY2018-Q3AdvancedAnnual report
「Clinical trials are being conducted for autologous cultured corneal epithelium, which is being developed under contract from NIDEK, and autologous cultured oral mucosal epithelium, for which development services have been undertaken from Osaka University, for the indication of limbal stem cell deficiency. The Company is preparing to file applications for marketing approval, including compiling clinical trial data.」
In addition to autologous cultured corneal epithelium, autologous cultured oral mucosal epithelium has also progressed to the stage of compiling clinical trial data and preparing applications for marketing approval. - FY2018-Q2RestatedAnnual report
「In its regenerative medicine products business, the Company advanced the manufacture and sale of JACE autologous cultured epidermis and JACC autologous cultured cartilage.」
The Company continues to manufacture and sell JACE and JACC, and continues development of JACC aimed at simplifying procedures and reducing invasiveness. - FY2018-Q1RestatedAnnual report
「The Company also advanced development aimed at simplifying procedures and reducing invasiveness as part of expanding JACC's indications.」
While continuing its policy of developing regenerative medicine products, the Company describes specific development initiatives for JACC aimed at simplifying procedures and reducing invasiveness. - FY2017-Q1RestatedAnnual report
「Under these circumstances, the Company advanced development of autologous cultured epidermis, autologous cultured cartilage, autologous cultured corneal epithelium and other products in its regenerative medicine products business.」
The Company continues to develop products including JACE, JACC and autologous cultured corneal epithelium. - FY2016First statedAnnual report
「The Company's principal business objective is to develop regenerative medicine products using tissue engineering and manufacture and sell those products to medical institutions for medical purposes.」
JACE, JACC and autologous cultured corneal epithelium are positioned as development pipeline products. Because the culture period and target indications are specified for each product, these items were organized as initiatives including their figures, timelines and methods.