Uncertainty in New Drug Research and Development
First written in FY2016. 16 of 38 entries say "Materialised", first in FY2017. Latest entry: 2026-10-22.
Kissei Pharmaceutical moved to the "Worse" side of this theme in 2017, 3 years before the typical company in this theme (2020).
The whole theme swung hardest in 2022: 20 of 40 companies on the "Worse" side.
4 other companies' latest entry also says "Worsened".
- FY2026MaterialisedAnnual report
「On 27 April 2026, FDA's Center for Drug Evaluation and Research (CDER) announced that it had proposed withdrawal of the product's approval in the United States, stating that newly obtained information had revealed that efficacy had not been demonstrated and that the application documents contained statements contrary to material facts.」
For the in-licensed product Tavneos, the regulatory authorities identified issues concerning efficacy and the approval application documents, resulting in actual regulatory problems related to R&D and approval uncertainty. - FY2025MaterialisedAnnual report
「KSP-0243 (development code), a treatment for ulcerative colitis discovered by the company, was discontinued because it failed to achieve its primary endpoint in the Phase II clinical trial conducted in the previous fiscal year.」
Uncertainty in new drug R&D became concrete when KSP-0243 failed to achieve its primary endpoint in the Phase II clinical trial and development was discontinued. - FY2024RestatedAnnual report
「The development of a new drug from research and development through approval and launch requires substantial expenditure and a lengthy period. … For compounds or products for which rights to development, marketing or other activities overseas have been licensed, progress may not proceed as expected due to the licensee's business performance or portfolio changes, or in connection with development in the licensed territories and responses to pharmaceutical regulations and other requirements.」
The company reconfirms the uncertainty regarding the cost, timeline, efficacy and approval timing of new drug development, as well as uncertainty arising from the business performance and portfolio changes of overseas licensees. - FY2024-Q2MaterialisedAnnual report
「Lovotirelin (generic name; development code: KPS-0373), a treatment for spinocerebellar degeneration, had its marketing approval application temporarily withdrawn in July of this year, and the Company is considering the feasibility of conducting additional clinical trials.」
Uncertainty in new drug R&D became concrete in the temporary withdrawal of the application for approval of KPS-0373 and the consideration of the feasibility of conducting additional clinical trials. - FY2024-Q1MaterialisedAnnual report
「Regarding the spinal and cerebellar degeneration treatment rovatirelin (generic name; development code: KPS-0373), we temporarily withdrew the application for approval in July this year and are considering the feasibility of conducting additional clinical trials.」
Uncertainty in new drug development became concrete in the temporary withdrawal of the application for approval of KPS-0373 and the consideration of the feasibility of conducting additional clinical trials. - FY2023-Q2RestatedAnnual report
「During the cumulative second quarter under review, there were no significant changes in the matters described in this quarterly report regarding the business and accounting conditions that management recognizes could materially affect the financial position, operating results and cash flows of the consolidated companies, or in the “Business and Other Risks” described in the securities report for the previous fiscal year.」
The company reconfirms that there have been no material changes to the previously disclosed major risks, including uncertainty in new drug R&D. - FY2023-Q1RestatedAnnual report
「During the three-month period ended 30 June, there were no new risks that management recognizes as having the potential to materially affect the financial position, operating results or cash flows of the consolidated companies, and no material changes to the business risks described in the annual securities report for the previous fiscal year.」
The company reconfirms that there have been no material changes to the previously disclosed major risks, including uncertainty in new drug R&D. - FY2022WorsenedAnnual report
「For compounds or products for which rights to development, marketing or other activities overseas have been licensed, development in the licensed territories and responses to pharmaceutical regulations and other requirements may not progress as expected.」
In addition to the existing uncertainties in R&D, the company has explicitly identified the risk that development progress in overseas licensed territories and responses to pharmaceutical regulations may not proceed as expected. - FY2022-Q3RestatedAnnual report
「During the cumulative third quarter under review, there were no significant changes in the matters described in this quarterly report regarding the business and accounting conditions that management recognizes could materially affect the financial position, operating results and cash flows of the consolidated companies, or in the “Business and Other Risks” described in the securities report for the previous fiscal year.」
The company reconfirms that there have been no material changes to the previously disclosed major risks, including uncertainty in new drug R&D. - FY2022-Q2RestatedAnnual report
「During the cumulative second quarter under review, there were no significant changes in the matters described in this quarterly report regarding the business and accounting conditions that management recognizes could materially affect the financial position, operating results and cash flows of the consolidated companies, or in the “Business and Other Risks” described in the securities report for the previous fiscal year.」
The company reconfirms that there have been no material changes to the previously disclosed major risks, including uncertainty in new drug R&D. - FY2021-Q2RestatedAnnual report
「During the cumulative second quarter under review, there were no significant changes in the matters described in this quarterly report regarding the business and accounting conditions that management recognizes could materially affect the financial position, operating results and cash flows of the consolidated companies, or in the “Business and Other Risks” described in the securities report for the previous fiscal year.」
The company reconfirms that there have been no material changes to the previously disclosed major risks, including uncertainty in new drug R&D. - FY2021-Q1RestatedAnnual report
「For KPS-0373, a treatment for spinocerebellar degeneration (development code; generic name: lobatirelin), the Phase III clinical trial has been completed. The company is conducting a detailed analysis of the results obtained from previous trials, including subgroup analyses by disease severity, and is continuing discussions with the regulatory authorities.」
Following completion of the Phase III trial of KPS-0373, detailed analysis based on the primary endpoint results and discussions with the regulatory authorities are continuing. - FY2020MaterialisedAnnual report
「YS110 (development code), which we acquired from ワイズ・エー・シー株式会社 with the rights to develop and market it in Japan and had been developing as a treatment for malignant mesothelioma, was discontinued following a comprehensive review of its development strategy, our R&D pipeline and other factors, and the rights were returned to the company.」
For a product in the R&D pipeline, development was discontinued and the rights were returned following a review of the development strategy and other factors. - FY2020-Q3RestatedAnnual report
「The Phase III clinical trial of KPS-0373, a treatment for spinocerebellar degeneration (development code; generic name: lovotirelin), has been completed. The Company is conducting detailed analyses of the results obtained in the trials, including subgroup analyses by severity, while consulting with the regulatory authorities. The results of these pooled analyses (post hoc analyses) have recently been published in a medical journal.」
The company reconfirms that, following the absence of a significant improvement in the primary endpoint for KPS-0373, detailed analyses, including subgroup analyses, and discussions with the regulatory authorities are continuing. - FY2020-Q2RestatedAnnual report
「For KPS-0373, a treatment for spinocerebellar degeneration (development code; generic name: lobatirelin), the Phase III clinical trial has been completed. The company is conducting a detailed analysis of the results obtained from previous trials, including subgroup analyses by disease severity, and is continuing discussions with the regulatory authorities.」
Following completion of the Phase III trial of KPS-0373, detailed analyses, including subgroup analyses, and discussions with the regulatory authorities are continuing. The company reconfirms the status of its response to uncertainty in R&D. - FY2020-Q1RestatedAnnual report
「For KPS-0373, a treatment for spinocerebellar degeneration (development code; generic name: lobatirelin), the Phase III clinical trial has been completed. The company is conducting a detailed analysis of the results obtained from previous trials, including subgroup analyses by disease severity, and has begun discussions with the regulatory authorities.」
Detailed analysis and discussions with the regulatory authorities are continuing following the absence of a significant improvement in the primary endpoint in the Phase III trial of KPS-0373. - FY2019RestatedAnnual report
「For KPS-0373, a treatment for spinocerebellar degeneration (development code; generic name: lobatirelin), the change in the SARA total score assessing ataxia, the primary endpoint in the Phase III clinical trial, did not show a statistically significant improvement compared with placebo. The company is currently conducting a detailed analysis of the results obtained from previous trials, including subgroup analyses by disease severity.」
The company reconfirms that no statistically significant improvement was observed in the primary endpoint for KPS-0373 and that detailed analyses, including subgroup analyses, are continuing. - FY2019-Q3RestatedAnnual report
「For KPS-0373, a treatment for spinocerebellar degeneration (development code; generic name: lobatirelin), the change in the SARA total score assessing ataxia, the primary endpoint in the Phase III clinical trial, did not show a statistically significant improvement compared with placebo. The company is currently conducting a detailed analysis of the results obtained from previous trials, including subgroup analyses by disease severity.」
The company reconfirms that no statistically significant improvement was observed in the primary endpoint for KPS-0373 and that detailed analyses, including subgroup analyses, are continuing. - FY2019-Q2RestatedAnnual report
「For KPS-0373, a treatment for spinocerebellar degeneration (development code; generic name: lobatirelin), the change in the SARA total score assessing ataxia, the primary endpoint in the Phase III clinical trial, did not show a statistically significant improvement compared with placebo. The company is continuing to conduct a detailed analysis of the results obtained from this trial, including subgroup analyses by disease severity.」
The company reconfirms that no significant improvement was observed in the primary endpoint for KPS-0373 and that detailed analyses, including subgroup analyses, are continuing. - FY2019-Q1MaterialisedAnnual report
「For KPS-0373, a treatment for spinocerebellar degeneration (development code; generic name: lobatirelin), the change in the SARA total score assessing ataxia, which was the primary endpoint in the Phase III clinical trial, did not show a statistically significant improvement compared with placebo. The company is currently conducting a detailed analysis of the results obtained from this trial, including subgroup analyses by disease severity.」
No statistically significant improvement was observed in the primary endpoint of the Phase III clinical trial of KPS-0373, representing a specific manifestation of uncertainty in new drug R&D. - FY2018RestatedAnnual report
「The development of a new drug from research and development through approval and launch requires substantial expenditure and a lengthy period. In drug discovery research, there is no guarantee that useful compounds will be discovered as planned. Nor can the company reliably predict whether the expected efficacy of a new drug under development or an additional indication can be demonstrated, or when approval will be obtained.」
Uncertainty regarding R&D costs and timelines, compound discovery, proof of efficacy and the timing of approval remains a risk. - FY2018-Q3RestatedAnnual report
「No new business or other risks arose during the cumulative third quarter of the fiscal year under review. There were also no material changes to the business and other risks described in the securities report for the previous fiscal year.」
The company reconfirms that there have been no material changes to the previously disclosed business and other risks, including uncertainty in new drug R&D. - FY2018-Q2RestatedAnnual report
「There were no newly arising business or other risks during the cumulative second quarter of the current consolidated fiscal year. In addition, there were no material changes to the business or other risks described in the annual securities report for the previous fiscal year.」
The company reconfirms that there have been no material changes to the previously disclosed business and other risks, including uncertainty in new drug R&D. - FY2017MaterialisedAnnual report
「KCT-0809, a treatment for dry eye associated with Sjögren's syndrome that we had been co-developing with テイカ製薬株式会社 in a Phase III clinical trial, was discontinued because the expected efficacy could not be clearly demonstrated.」
The company states that the expected efficacy of a product under development could not be clearly confirmed and that development was discontinued, representing a specific manifestation of uncertainty in R&D. - FY2016First statedAnnual report
「The development of a new drug from research and development through approval and launch requires substantial expenditure and a lengthy period. In drug discovery research, there is no guarantee that useful compounds will be discovered as planned. Nor can the company reliably predict whether the expected efficacy of a new drug under development or an additional indication can be demonstrated, or when approval will be obtained.」
The company identifies uncertainty regarding R&D costs and timelines, compound discovery, proof of efficacy and the timing of approval.