Obtaining Marketing Approval for Cell Therapy Products
First written in FY2017-Q1. 19 of 23 entries say "Restated". Latest entry: 2026-08-13.
1 other company's latest entry also says "Advanced".
- 2026-08-13AdvancedEarnings
「We are currently determining our development policy through face-to-face consultations and other discussions with the Pharmaceuticals and Medical Devices Agency (PMDA) toward exercising the option and starting the clinical trial at an early stage, while proceeding with regulatory activities toward the launch of a domestic clinical trial.」
For a new regenerative medical product candidate, the company has progressed to the stage of face-to-face consultations with PMDA and regulatory activities toward exercising the option and starting a clinical trial at an early stage. - FY2024-Q2RestatedAnnual report
「In the regenerative medicine products business, we aim to monetize regenerative medicine products at an early stage while monitoring development trends for regenerative medicine products in Japan and overseas and undertaking activities with a view to acquiring and expanding those pipelines.」
The policy of considering early monetization of regenerative medicine products and pipeline acquisitions and expansion in Japan and overseas has continued. - FY2023RestatedAnnual report
「In the regenerative medicine products business, the company is accelerating development with a view to achieving profitability at an early stage, while monitoring development trends for regenerative medicine products in Japan and overseas and pursuing activities aimed at acquiring and expanding such pipelines.」
The company continues to pursue a policy of accelerating the development of regenerative medicine products, achieving profitability at an early stage, and acquiring and expanding its pipeline. - FY2023-Q2RestatedAnnual report
「In the regenerative medicine products segment, the company is prioritising the development of promising, high-potential candidates with a view to obtaining marketing approval at an early stage.」
The company continues to pursue a policy of prioritising the development of promising, high-potential candidates with a view to obtaining marketing approval at an early stage. - FY2023-Q1RestatedAnnual report
「In the regenerative medicine products business, we aim to monetize regenerative medicine products at an early stage while monitoring development trends for regenerative medicine products in Japan and overseas and undertaking activities with a view to acquiring and expanding those pipelines.」
The company continues to pursue a development policy focused on bringing regenerative medicine products to profitability at an early stage through the acquisition and expansion of its pipeline. - FY2022-Q3RestatedAnnual report
「In the regenerative medicine products business, we aim to monetize regenerative medicine products at an early stage while monitoring development trends for regenerative medicine products in Japan and overseas and undertaking activities with a view to acquiring and expanding those pipelines.」
The company continues to pursue a development policy focused on bringing regenerative medicine products to profitability at an early stage through the acquisition and expansion of its pipeline. - FY2022-Q2RestatedAnnual report
「In the regenerative medicine products business, we aim to monetize regenerative medicine products at an early stage while monitoring development trends for regenerative medicine products in Japan and overseas and undertaking activities with a view to acquiring and expanding those pipelines.」
The company continues to pursue a policy of bringing regenerative medicine products to profitability at an early stage while considering the acquisition and expansion of its pipeline. - FY2021-Q3RestatedAnnual report
「We aim to monetize regenerative medicine products at an early stage while monitoring development trends for regenerative medicine products in Japan and overseas and undertaking activities with a view to acquiring and expanding those pipelines.」
The company continues to pursue a policy of considering the acquisition and expansion of its pipeline with a view to bringing regenerative medicine products to profitability at an early stage. - FY2021-Q2RestatedAnnual report
「In the regenerative medicine products segment, the company is prioritising the development of promising, high-potential candidates with a view to obtaining marketing approval at an early stage, while」
The company continues to pursue a policy of prioritising the development of promising, high-potential candidates with a view to obtaining early approval for regenerative medicine products. - FY2021-Q1RestatedAnnual report
「In the regenerative medicine products business, we aim to monetize regenerative medicine products at an early stage while monitoring development trends for regenerative medicine products in Japan and overseas and undertaking activities with a view to acquiring and expanding those pipelines.」
The company continues to pursue a policy of considering the acquisition and expansion of its pipeline with a view to bringing regenerative medicine products to profitability at an early stage. - FY2020-Q3RestatedAnnual report
「This will enable the manufacture of regenerative medicine products at the Shinagawa CPF, further develop the manufacturing structure and initiatives for the commercialization of regenerative and cellular medicine, and expand efforts to bring regenerative medicine products to market.」
The company has indicated a policy of pursuing the commercialisation and launch of regenerative medicine products based on the manufacturing licence for Shinagawa CPF (cell processing facility). - FY2020-Q1RestatedAnnual report
「In the regenerative medicine products business segment, the Company will prioritize the development of promising and highly viable seeds with the aim of obtaining manufacturing and marketing approval at an early stage.」
The Company continues to pursue a policy of prioritizing promising and highly viable seeds with the aim of obtaining early approval for regenerative medicine products. - FY2019RestatedAnnual report
「As in the previous fiscal year, the Company is continuing preparations to begin clinical trials to obtain manufacturing and marketing approval for the autologous cultured cartilage product “MDNT01,” which targets knee cartilage injuries, and the dendritic cell vaccine “ATL-DC-101,” which targets adult T-cell leukemia.」
The Company continues to prepare for the start of clinical trials to obtain manufacturing and marketing approval for MDNT01 and ATL-DC-101. - FY2019-Q3RestatedAnnual report
「In the regenerative medicine products business segment, the Company will prioritize the development of promising and highly viable seeds with the aim of obtaining manufacturing and marketing approval at an early stage.」
The Company has presented a development policy that prioritizes promising and highly viable seeds with the aim of obtaining early approval for regenerative medicine products. - FY2019-Q2RestatedAnnual report
「The Company will strengthen its development structure to obtain early approval for the autologous cultured cartilage product “MDNT01” and “ATL-DC-101.”」
The Company continues to pursue a policy of strengthening its development structure to obtain early approval for MDNT01 and ATL-DC-101. - FY2019-Q1RestatedAnnual report
「The Company will strengthen its development structure to obtain early approval for the autologous cultured cartilage product “MDNT01” and “ATL-DC-101.”」
The Company continues to pursue a policy of strengthening its development structure to obtain early approval for MDNT01 and ATL-DC-101. - FY2018-Q3RestatedAnnual report
「Going forward, under this agreement, the Company will begin clinical trials using the technology for knee joint cartilage injuries during 2018 and aims to obtain manufacturing and marketing approval as a regenerative medicine product in 2021. On 22 March 2018, the Company also entered into a joint development agreement with the National Hospital Organization, an Independent Administrative Agency (the “National Hospital Organization”), for the purpose of obtaining manufacturing and marketing approval as a regenerative medicine product for the dendritic cell vaccine “ATL-DC-101,” which targets adult T-cell leukemia. The Company is advancing development jointly with the National Hospital Organization, with the aim of beginning clinical trials during 2018 and obtaining approval in 2021.」
The Company continues to pursue a plan to begin clinical trials for MDNT01 and ATL-DC-101 during 2018 and obtain approval in 2021. - FY2018-Q2AdvancedAnnual report
「On 22 March 2018, the Company also entered into a joint development agreement with the National Hospital Organization, an Independent Administrative Agency (the “National Hospital Organization”), for the purpose of obtaining manufacturing and marketing approval as a regenerative medicine product for the dendritic cell vaccine “ATL-DC-101,” which targets adult T-cell leukemia. The Company is advancing development jointly with the National Hospital Organization with the aim of obtaining approval in 2021.」
Regarding the target for obtaining approval for cellular medicine products, the Company specified a joint development agreement for ATL-DC-101 in addition to NeoCart and a target of obtaining approval in 2021. - FY2018-Q1AdvancedAnnual report
「Going forward, under this agreement, the Company will begin clinical trials using the technology for knee joint cartilage injuries and aims to obtain manufacturing and marketing approval as a regenerative medicine product in 2021.」
For NeoCart, the Company presented a specific plan to begin clinical trials for knee joint cartilage injuries and obtain manufacturing and marketing approval in 2021. - FY2017RestatedAnnual report
「The Company will further accelerate the development of cellular medicine products and aims to achieve significant growth by obtaining manufacturing and marketing approval.」
The Company continues to pursue its growth target through accelerated development of cellular medicine products and obtaining manufacturing and marketing approval. - FY2017-Q3RestatedAnnual report
「In the cell therapy products business, we are preparing to obtain marketing approval at an early stage for cell therapy products, a type of regenerative medicine product, by using the conditional and time-limited approval system.」
The Company continues to pursue a policy of obtaining manufacturing and marketing approval for cellular medicine products at an early stage and using the conditional and time-limited approval system to do so. - FY2017-Q2RestatedAnnual report
「In the cell therapy products business, we are preparing to obtain marketing approval at an early stage for cell therapy products, a type of regenerative medicine product, by using the conditional and time-limited approval system.」
The Company continues to work toward obtaining manufacturing and marketing approval for cellular medicine products under the conditional and time-limited approval system, as preparation for obtaining approval at an early stage. - FY2017-Q1First statedAnnual report
「We are working to obtain marketing approval for cell therapy products by promoting development through joint research with university hospitals and other institutions and exploring promising product candidates in Japan and overseas.」
The Company aims to obtain marketing approval for cell therapy products through joint development with university hospitals and other institutions and by exploring product candidates in Japan and overseas.