Exclusive development and marketing of Stemchymal® in Japan
First written in FY2017-Q2. 21 of 35 entries say "Advanced", first in FY2017-Q3. Latest entry: 2026-09-29.
No other company in this theme has enough history to compare yet.
- FY2026-H1RestatedAnnual report
「Our group is preparing an application for manufacturing and marketing approval, making use of these results and the benefits of the designation, so that we can deliver a new treatment option to patients suffering from spinocerebellar degeneration as soon as possible.」
For Stemchymal, the company has reaffirmed its policy of proceeding with preparations for a domestic application for manufacturing and marketing approval. - FY2025AdvancedAnnual report
「In November 2024, ステミネント社 was certified by the Minister of Health, Labour and Welfare as a foreign manufacturer of regenerative medicine products, satisfying one of the requirements for obtaining domestic manufacturing and marketing approval.」
For Stemchymal, certification of the partner as a foreign manufacturer satisfied one of the requirements for obtaining domestic manufacturing and marketing approval. The plan to proceed with preparations for the application for approval remains unchanged. - FY2025-H1RestatedAnnual report
「We are preparing an application for approval so that new treatment options can be delivered as soon as possible to patients fighting the disease.」
For Stemchymal, the company has reaffirmed its policy of proceeding with preparations for an application for approval following evaluation of the results of the domestic Phase II clinical trial. - FY2024AdvancedAnnual report
「A patent for the product was also granted in Japan in January 2024.」
For Stemchymal, the company disclosed the intellectual property milestone of obtaining a patent in Japan. It states that preparations for an application for approval will continue. - FY2024-Q3RestatedAnnual report
「We are preparing an application for approval so that new treatment options can be delivered as soon as possible to patients fighting the disease.」
For Stemchymal, the company has reaffirmed its policy of proceeding with preparations for an application for approval following disclosure of the results of the domestic Phase II clinical trial. - FY2024-Q2AdvancedAnnual report
「In the Phase II clinical trial conducted by ステミネント社 in Taiwan, there were also no safety issues, and an analysis of the change in SARA scores in the subgroup with a high baseline score showed an improvement effect in the active-treatment group compared with the placebo group. The results of the clinical trial in Taiwan were similar to those in Japan and supported the Japanese data.」
For Stemchymal, the Phase II clinical trial in Taiwan also showed no safety issues, and an improvement effect was observed in the subgroup with a high baseline score, supporting the results of the clinical trial in Japan. - FY2024-Q1AdvancedAnnual report
「No serious adverse events were observed in any subjects, confirming the safety of the treatment. Regarding efficacy, statistical analysis of the change in the primary endpoint, the SARA score*, from baseline (Visit 2, before dosing) to Week 52 (Visit 8) showed a statistically significant improvement in the active-treatment group compared with the placebo group in the subgroup with a baseline score of 11 or higher (P value: 0.042).」
In the Phase II clinical trial of Stemchymal in Japan, no serious adverse events were observed in any subjects, confirming safety. In the subgroup with a baseline score of 11 or higher, the active-treatment group showed statistically significant improvement compared with the placebo group, and the results were disclosed in May 2023. The company states that it will proceed with preparations for an application for approval. - FY2023-Q3RestatedAnnual report
「We are currently conducting data analysis and evaluation and will proceed with the application for approval.」
For Stemchymal, the company has reaffirmed its plan to proceed with data analysis and evaluation and prepare an application for approval after the observation period for all subjects in the Phase II clinical trial in Japan ends. - FY2023-Q2AdvancedAnnual report
「In the Phase II clinical trial in Japan, dosing was initiated in the first subject at Nagoya University in February 2020, dosing of all subjects was completed in May 2021, and the observation period for all subjects ended in May 2022.」
For Stemchymal, the observation period for all subjects in the Phase II clinical trial in Japan ended in May 2022, bringing the program to the stage of data analysis and evaluation and preparation for an application for approval. - FY2023-Q1AdvancedAnnual report
「A Phase II clinical trial is being conducted in Japan. In February 2020, dosing was initiated in the first subject at Nagoya University, dosing of all subjects was completed in May 2021, and the observation period for all subjects ended in May 2022.」
For Stemchymal, the observation period for all subjects in the Phase II clinical trial in Japan ended in May 2022, bringing the program to the stage of data analysis and evaluation and preparation for an application for approval. - FY2022-Q3AdvancedAnnual report
「In Taiwan, ステミネント社 has completed the Phase II clinical trial, and it has been confirmed that no serious safety issues have been observed to date. Efficacy data are currently being analyzed.」
For Stemchymal, the Phase II clinical trial in Taiwan was completed, bringing the program to the stage at which no serious safety issues had been confirmed. The efficacy data are under analysis. - FY2022-Q2RestatedAnnual report
「The trial uses a highly rigorous design: multicenter, placebo-controlled, randomized, double-blind and parallel-group. Going forward, we will evaluate safety and efficacy and aim to obtain manufacturing and marketing approval at an early date. The trial has proceeded on schedule to date without being affected by COVID-19.」
For Stemchymal, the company has reaffirmed its plan to evaluate safety and efficacy and seek approval at an early date after dosing of all subjects has been completed, as well as its statement that the clinical trial is proceeding on schedule. - FY2022-Q1AdvancedAnnual report
「A Phase II clinical trial is being conducted in Japan. In February 2020, dosing was initiated in the first subject at Nagoya University, and in May 2021, dosing of all subjects was completed as scheduled.」
For Stemchymal, dosing of all subjects in the Phase II clinical trial in Japan was completed in May 2021, bringing the program to the stage of evaluating safety and efficacy and seeking approval. - FY2021AdvancedAnnual report
「A Phase II clinical trial is being conducted in Japan. In February 2020, dosing was initiated in the first subject at Nagoya University, and in February 2021, enrollment of all subjects was completed as scheduled.」
For Stemchymal, enrollment of all subjects in the Phase II clinical trial was completed in February 2021, bringing the program to the next stage of safety and efficacy evaluation. - FY2021-Q3RestatedAnnual report
「The clinical trial will be conducted at 10 medical institutions in Japan, with a total planned enrollment of 53 subjects, and is scheduled for completion in December 2021. The trial uses a highly rigorous design: multicenter, placebo-controlled, randomized, double-blind and parallel-group. Going forward, we will evaluate safety and efficacy and aim to obtain manufacturing and marketing approval at an early date.」
For Stemchymal, the company has reaffirmed the plan to complete the Phase II clinical trial in Japan, involving 10 medical institutions and 53 subjects, in December 2021, as well as the trial design and policy of seeking approval at an early date. - FY2021-Q2RestatedAnnual report
「The clinical trial will be conducted at 10 medical institutions in Japan, with a total planned enrollment of 53 subjects, and is scheduled for completion in December 2021. The trial uses a highly rigorous design: multicenter, placebo-controlled, randomized, double-blind and parallel-group. Going forward, we will evaluate safety and efficacy and aim to obtain manufacturing and marketing approval at an early date. The trial has proceeded on schedule to date without being affected by COVID-19.」
For Stemchymal, the company has reaffirmed its plan to complete the Phase II clinical trial in Japan, involving 10 medical institutions and 53 subjects, in December 2021, as well as its on-schedule progress. - FY2021-Q1RestatedAnnual report
「The clinical trial will be conducted at 10 medical institutions in Japan, with a total planned enrollment of 53 subjects, and is scheduled for completion in December 2021.」
For Stemchymal, the company has reaffirmed its plan to complete the Phase II clinical trial in Japan, involving 10 medical institutions and 53 subjects, in December 2021. It also states that the trial is proceeding on schedule without being affected by COVID-19. - FY2020AdvancedAnnual report
「In February 2020, dosing was initiated in the first subject in the Phase II clinical trial at Nagoya University. The clinical trial will be conducted at 10 medical institutions in Japan, with a total planned enrollment of 53 subjects, and is scheduled for completion in December 2021.」
For Stemchymal, initial dosing began in the Phase II clinical trial in Japan, bringing the program to the specific clinical trial stage of 10 medical institutions, 53 subjects and scheduled completion in December 2021. - FY2020-Q3AdvancedAnnual report
「During the nine-month period ended December 31, we have made steady progress in preparations to begin the clinical trial, including concluding clinical trial agreements with Nagoya University and the National Center of Neurology and Psychiatry Hospital. We plan to begin the clinical trial at an early date and gradually increase the number of clinical trial sites.」
For Stemchymal, clinical trial agreements were concluded with Nagoya University and the National Center of Neurology and Psychiatry Hospital, bringing the program to the stage of specific preparations for starting the clinical trial. - FY2020-Q2AdvancedAnnual report
「Meanwhile, ステミネント社 is conducting a Phase II clinical trial of Stemchymal for the disease in Taiwan and has already completed dosing of all patients. In addition, the U.S. Food and Drug Administration (FDA) approved an Investigational New Drug (IND) application for Stemchymal in the United States in July 2018, and the clinical trial will subsequently proceed there as well.」
For Stemchymal, overseas development progressed with dosing completed for all patients in the Phase II clinical trial in Taiwan and the IND approved by the FDA in the United States. - FY2020-Q1RestatedAnnual report
「In July 2018, the Pharmaceuticals and Medical Devices Agency (PMDA) completed its prescribed review of the clinical trial notification submitted for a Japanese clinical trial targeting spinocerebellar degeneration. As a result, we are now able to conduct a Phase II clinical trial of Stemchymal in Japan. We are preparing to conclude the prescribed agreements with the domestic medical institutions that will conduct the clinical trial, while aiming to obtain approval at an early date by making use of Japan’s regulatory framework.」
For Stemchymal, the company has reaffirmed its plan to prepare for a Phase II clinical trial and seek approval at an early date following completion of the PMDA review. - FY2019-Q3AdvancedAnnual report
「In December 2018, Stemchymal was designated as a regenerative medicine product for rare diseases following approval by the Minister of Health, Labour and Welfare. As a result, it is eligible for support measures including subsidies covering up to 50% of development-related expenses, preferential tax treatment and priority review.」
For Stemchymal, designation as a regenerative medicine product for rare diseases was obtained in December 2018, bringing the program to the stage at which it is eligible for support measures including subsidies of up to 50%, preferential tax treatment and priority review. - FY2019-Q2AdvancedAnnual report
「In July 2018, the Pharmaceuticals and Medical Devices Agency (PMDA) completed its prescribed review of the clinical trial notification submitted for a Japanese clinical trial targeting spinocerebellar degeneration. As a result, we are now able to conduct a Phase II clinical trial of Stemchymal in Japan. We are preparing to conclude the prescribed agreements with the domestic medical institutions that will conduct the clinical trial, while aiming to obtain approval at an early date by making use of Japan’s regulatory framework.」
For Stemchymal, the PMDA review of the clinical trial notification has been completed, allowing the program to advance to the stage at which a Phase II clinical trial can be conducted in Japan. - FY2019-Q1AdvancedAnnual report
「In Japan, we are currently preparing for the clinical trial and aim to submit the clinical trial notification during the current fiscal year.」
For Stemchymal, a specific milestone was presented: submission of the clinical trial notification during the current fiscal year, following the preparation stage. - FY2018SoftenedAnnual report
「We are currently preparing a clinical trial in Japan targeting spinocerebellar degeneration for Stemchymal, a regenerative medicine product introduced from ステミネント社. We plan to begin the clinical trial at an early date and submit an application for approval around 2020.」
For Stemchymal, preparations for the clinical trial and the plan to submit an application for approval around 2020 remain unchanged. However, this filing does not specify the previously stated timing of “starting the clinical trial in 2018,” instead referring to an “early start.” - FY2018-Q3RestatedAnnual report
「As a step preceding the clinical application of human iPS cells, the Company is preparing for clinical trials of Stemchymal, a regenerative medicine product using human somatic stem cells, and plans to begin the clinical trial in 2018.」
Reaffirming the plan to prepare for clinical trials of Stemchymal and begin the trial in 2018. - FY2018-Q1RestatedAnnual report
「The Company has entered into an exclusive license agreement for Stemchymal in Japan and plans to begin the clinical trial in 2018 and submit the application for approval around 2020. It is currently holding discussions with the relevant institutions in stages, aiming to begin the clinical trial in 2018.」
Reaffirming the plan for Stemchymal to begin clinical trials in Japan in 2018 and submit an application for approval around 2020. - FY2017SoftenedAnnual report
「In Japan, the Company plans to begin the clinical trial in 2018 as the business operator and submit the application for approval around 2020.」
For Stemchymal®, the timing changed from the previous description of a clinical trial in Japan beginning around autumn to winter 2017 to a trial beginning in 2018, and 2020 is now described as the planned timing for submitting an application for approval rather than obtaining approval. - FY2017-Q3AdvancedAnnual report
「Going forward, the Company and Steminent plan to work together for approximately 1 year to prepare for the clinical trial, with the trial in Japan scheduled to begin around autumn to winter 2017. Monetization is expected through conditional and time-limited approval and the start of conditional sales around 2020, while the Company aims to maximize revenue through full approval and launch around 2023.」
For Stemchymal®, the Company presented a specific development and sales plan consisting of approximately 1 year of clinical trial preparation, commencement of the trial around autumn to winter 2017, conditional and time-limited approval around 2020, and full approval and launch around 2023. - FY2017-Q2First statedAnnual report
「Under this agreement, the Company acquired the exclusive rights to develop Stemchymal® in Japan as a treatment for spinocerebellar degeneration as a new business and to sell the treatment exclusively in Japan after its launch. Going forward, the Company will seek an early launch through product development and clinical trials for Stemchymal® in accordance with Japanese laws and regulations, using the aforementioned regulatory framework, while Steminent will provide development support as needed.」
The Company entered into an agreement with Taiwan-based Steminent and acquired exclusive development and sales rights in Japan for Stemchymal® for spinocerebellar degeneration, as well as preferential negotiation rights for other diseases. It invested approximately ¥100 million in connection with the agreement and plans total payments of ¥400 million, including compensation linked to development milestones. This is the first product the Company will handle as a pharmaceutical product, and it is positioned as the first step toward full-scale entry into the regenerative medicine field.