Expansion of the Cell Therapy and Regenerative Medicine Business
First written in FY2016. 15 of 24 entries say "Advanced", first in FY2017-Q1. Latest entry: FY2025-H1.
0 other companies' latest entry also says "Dropped".
- FY2025-H1DroppedAnnual report
「We had been developing Temcell® HS Injection for the new expanded indication of neonatal hypoxic-ischemic encephalopathy (development code: JR-031HIE), but decided to discontinue the development after the Phase I/II clinical trial failed to demonstrate the expected efficacy.」
Development of JR-031HIE was discontinued after the Phase I/II trial failed to demonstrate the expected efficacy. - FY2024-Q3SoftenedAnnual report
「The Phase I/II clinical trial for neonatal hypoxic-ischemic encephalopathy (development code: JR-031HIE), the new expanded indication of Temcell® HS Injection, has been completed. Future development plans are under consideration.」
Following completion of the Phase I/II trial for JR-031HIE, future development plans remain under consideration, with the next development stage and timing not yet specified. - FY2024-Q2AdvancedAnnual report
「The Phase I/II clinical trial for neonatal hypoxic-ischemic encephalopathy (development code: JR-031HIE), the new expanded indication of Temcell® HS Injection, has been completed. Final analysis is currently under way for the results of an observational study whose primary purposes are to follow long-term safety and efficacy.」
For JR-031HIE, following completion of the Phase I/II trial, the program moved to the final analysis stage of an observational study to assess long-term safety and efficacy. - FY2024-Q1AdvancedAnnual report
「The Phase I/II clinical trial for neonatal hypoxic-ischemic encephalopathy (development code: JR-031HIE), the new expanded indication of Temcell® HS Injection, has been completed and is currently under analysis.」
For the JR-031HIE expanded indication of Temcell® HS Injection, the Phase I/II clinical trial was completed and the program moved to the analysis stage. - FY2023AdvancedAnnual report
「The Phase I/II clinical trial for neonatal hypoxic-ischemic encephalopathy (development code: JR-031HIE), the new expanded indication of Temcell® HS Injection, has been completed and is currently under analysis.」
For the JR-031HIE expanded indication of Temcell® HS Injection, the Phase I/II clinical trial was completed and the program moved to the analysis stage. Although the agreement to terminate joint development of JTR-161/JR-161 with Teijin Limited was reached, development of other indications continues across the regenerative medicine business. - FY2022SoftenedAnnual report
「For JTR-161/JR-161, a regenerative medicine product using allogeneic dental pulp-derived stem cells for acute-phase cerebral infarction that had been jointly developed with Teijin Limited, we agreed in April 2022 to terminate the joint development.」
The company agreed in April 2022 to terminate the joint development of JTR-161/JR-161 with Teijin Limited. The clinical trial for the expanded indication of Temcell® HS Injection in neonatal hypoxic-ischemic encephalopathy is continuing. - FY2021DroppedAnnual report
「In March 2021, we decided to discontinue development aimed at expanding the indication of Temcell® HS Injection to epidermolysis bullosa (development code: JR-031EB).」
For the expanded indication of Temcell® HS Injection in epidermolysis bullosa (JR-031EB), development was discontinued after the marketing authorization application was withdrawn. - FY2021-Q1RestatedAnnual report
「In July 2019, we began a clinical Phase I/II trial for the new expanded indication of Temcell® HS Injection in neonatal hypoxic-ischemic encephalopathy (development code: JR-031HIE).」
The company reconfirmed that the Phase I/II clinical trial for the JR-031HIE expanded indication of Temcell® HS Injection had begun. It also stated that the Phase I/II clinical trial for JTR-161/JR-161 had begun in February 2019. - FY2020-Q3RestatedAnnual report
「In the cell and regenerative medicine field, we entered into a joint development agreement and a licence agreement with Teijin Limited in July 2017 for JTR-161/JR-161, a regenerative medicine product using allogeneic dental pulp-derived stem cells (DPCs) for acute-phase cerebral infarction, and began patient dosing in a Phase I/II clinical trial in February last year. In addition, in July last year we began a Phase I/II clinical trial for the new expanded indication of Temcell® HS Injection in neonatal hypoxic-ischemic encephalopathy (development code: JR-031HIE).」
The company reconfirmed the start of patient dosing in the Phase I/II clinical trial for JTR-161/JR-161 and the start of the Phase I/II clinical trial for the JR-031HIE expanded indication of Temcell® HS Injection. - FY2020-Q2AdvancedAnnual report
「In the cell and regenerative medicine field, the company entered into a joint development agreement and license agreement with Teijin Limited in July the year before last for JTR-161/JR-161, a regenerative medicine product using allogeneic dental pulp-derived stem cells for acute ischemic stroke, and began administering the product to patients in a Phase I/II clinical trial in February this year. In addition, it began a Phase I/II clinical trial in July this year for a new indication of Temcell® HS Inj. in neonatal hypoxic-ischemic encephalopathy (development code: JR-031HIE).」
A patient-dosing Phase I/II clinical trial began for JTR-161/JR-161, and a clinical trial also began for the expanded indication of Temcell® HS Injection in neonatal hypoxic-ischemic encephalopathy. - FY2020-Q1AdvancedAnnual report
「In addition, in July this year we began a Phase I/II clinical trial for the new expanded indication of Temcell® HS Injection in neonatal hypoxic-ischemic encephalopathy (development code: JR-031HIE).」
For the expanded indication of Temcell® HS Injection in neonatal hypoxic-ischemic encephalopathy, a Phase I/II clinical trial began. - FY2019AdvancedAnnual report
「In addition, in March this year we filed a marketing authorization application for the added indication of Temcell® HS Injection in epidermolysis bullosa (development code: JR-031EB). JR-031EB had been designated by the Ministry of Health, Labour and Welfare as a regenerative medicine product for a rare disease in October last year.」
For the added indication of Temcell® HS Injection in epidermolysis bullosa, the company filed a marketing authorization application following its designation as a regenerative medicine product for a rare disease. - FY2019-Q3AdvancedAnnual report
「In the cell and regenerative medicine field, we entered into a joint development agreement and a licence agreement with Teijin Limited last July for JTR-161, a regenerative medicine product using allogeneic dental pulp-derived stem cells (DPCs) for acute-phase cerebral infarction, and began a Phase I/II clinical trial in October last year. On 1 October last year, Temcell® HS Injection, a human allogeneic bone-marrow-derived mesenchymal stem cell product undergoing a physician-initiated clinical trial at Osaka University Hospital, was designated by the Ministry of Health, Labour and Welfare as a regenerative medicine product for a rare disease for its expanded indication in epidermolysis bullosa. Preparations are under way with the aim of filing a marketing authorization application during fiscal 2018.」
The company stated that JTR-161 had begun a Phase I/II clinical trial. For the expanded indication of Temcell® HS Injection in epidermolysis bullosa, it received designation as a regenerative medicine product for a rare disease and is preparing to file a marketing authorization application during fiscal 2018. - FY2019-Q2AdvancedAnnual report
「In the cell and regenerative medicine field, we entered into a joint development agreement and a licence agreement with Teijin Limited last July for JTR-161, a regenerative medicine product using allogeneic dental pulp-derived stem cells (DPCs) for acute-phase cerebral infarction, and began a Phase I/II clinical trial in October this year.」
For JTR-161, which is being jointly developed with Teijin Limited, a Phase I/II clinical trial began in October. - FY2019-Q1RestatedAnnual report
「In the cell and regenerative medicine field, we entered into a joint development agreement and a licence agreement with Teijin Limited last July for JTR-161, a regenerative medicine product using allogeneic dental pulp-derived stem cells (DPCs) for acute-phase cerebral infarction, and are advancing research and development.」
Joint research and development has continued following the JTR-161 joint development and licence agreements with Teijin Limited. No progress to a new trial or marketing authorization application has been reported. - FY2018AdvancedAnnual report
「Since its launch in February the year before last, Temcell® HS Injection has continued to receive high evaluations from medical institutions as a new treatment option for acute graft-versus-host disease (GVHD) following hematopoietic stem cell transplantation. In October last year, restrictions on the medical institutions authorized to sell the product, which had previously been limited to clinical-trial sites, were lifted, making it available at a broader range of medical institutions. Sales have increased steadily along with the number of treated cases.」
Restrictions on medical institutions authorized to sell Temcell® HS Injection were lifted in October 2017, expanding the number of institutions able to use it. Sales increased 124.3% year on year as the number of treated cases rose. A physician-initiated clinical trial is continuing for an expanded indication in epidermolysis bullosa. - FY2018-Q3AdvancedAnnual report
「In the cell and regenerative medicine field, we entered into a joint development agreement and a licence agreement with Teijin Limited in July last year for JTR-161, a regenerative medicine product using allogeneic dental pulp-derived stem cells (DPCs) for acute-phase cerebral infarction, and are jointly advancing its development.」
The company stated that, following execution of the JTR-161 agreements with Teijin Limited, it is jointly advancing development with Teijin. - FY2018-Q2AdvancedAnnual report
「On 18 July this year, we entered into a joint development agreement and a licence agreement with Teijin Limited for JTR-161, a regenerative medicine product using allogeneic dental pulp-derived stem cells (DPCs) for acute-phase cerebral infarction.」
For a regenerative medicine product using dental pulp-derived stem cells for acute-phase cerebral infarction, the company advanced to a concrete partnership stage by entering into agreements with Teijin Limited. - FY2018-Q1AdvancedAnnual report
「As part of its licensing business, the company pursued negotiations with Teijin Limited to conclude a joint development agreement and license agreement for a regenerative medical product for acute ischemic stroke using allogeneic (homologous) dental pulp-derived stem cells (DPC) (development code: JTR-161).」
For a regenerative medicine product using dental pulp-derived stem cells, the company proceeded to concrete contract negotiations with Teijin Limited for joint development and a licence. - FY2017AdvancedAnnual report
「Temcell® HS Injection, launched in February 2016 as a regenerative medicine product for acute graft-versus-host disease following hematopoietic stem cell transplantation, is being considered for further development to expand its indications by leveraging the broad potential of mesenchymal stem cells (MSCs). We are also actively researching new proprietary cell sources and are targeting early commercialization by focusing on the potential of dental pulp-derived stem cells.」
In addition to considering expanded indications for Temcell® HS Injection, the company explicitly stated its efforts to achieve the early commercialization of dental pulp-derived stem cells. - FY2017-Q3RestatedAnnual report
「In the cell medicine field, we are also developing new regenerative medicine products at the Cell Processing Center completed in April last year.」
Development of new regenerative medicine products using the Cell Processing Center is continuing. - FY2017-Q2AdvancedAnnual report
「Epoetin Alfa BS Injection JCR, a recombinant human erythropoietin preparation for treating renal anemia, and Temcell® HS Injection, a regenerative medicine product launched in February this year, also progressed steadily, exceeding the initial plan.」
The company stated that the regenerative medicine product Temcell® HS Injection progressed ahead of the initial plan. - FY2017-Q1AdvancedAnnual report
「In sales, our core product, the recombinant human growth hormone preparation Growject® produced using recombinant DNA technology, increased sales after absorbing the impact of a drug-price reduction. Epoetin Alfa BS Injection JCR, a recombinant human erythropoietin preparation for treating renal anemia, and Temcell® HS Injection, a regenerative medicine product launched in February this year, also progressed steadily in line with the initial plan.」
The company stated that Temcell® HS Injection, launched in February 2016, progressed steadily in line with the initial plan. - FY2016First statedAnnual report
「Having developed Temcell® HS Injection over many years and accumulated expertise in cell therapy and regenerative medicine technologies, we believe that, as a pioneer in this field, we have a mission to pursue active business development in this area. In addition to the bone-marrow-derived Temcell® HS Injection, we are also conducting research on dental pulp-derived stem cells (DPCs) and other sources. Drawing on our strengths in cell culture technology, we will explore the potential of the full range of cell functions across a broad range of disease areas.」
Starting with Temcell® HS Injection, the company plans to expand its research targets to dental pulp-derived stem cells and other sources and explore applications across a broad range of disease areas.