Commercialization of a Molecularly Targeted DDS Drug for the Treatment of Liver Cirrhosis
First written in FY2016. 21 of 31 entries say "Restated". Latest entry: FY2026.
No other company in this theme has enough history to compare yet.
- FY2026SoftenedAnnual report
「In nucleic acid drug discovery, the company will focus on developing nucleic acid DDS (drug delivery system) design technology and signing license agreements. Regarding activities toward out-licensing the refractory cancer treatment, the company will determine its direction while considering the business environment and other factors.」
The wording regarding out-licensing activities for the refractory cancer treatment has softened from a policy of continuing those activities to determining the direction in light of the business environment. Meanwhile, the company states that it will focus on nucleic acid DDS design technology and license agreements. - FY2025-H1AdvancedAnnual report
「In nucleic acid therapeutics drug discovery, the Phase 1 clinical trial for the refractory cancer treatment was completed during the first quarter of the consolidated fiscal period, and the company will continue activities toward out-licensing.」
For the refractory cancer treatment, the Phase 1 trial was completed, advancing the project to the stage of continuing activities toward out-licensing. - FY2024-Q3RestatedAnnual report
「The company continues to work on clinical trials for the refractory cancer treatment toward out-licensing.」
In addition to the previously disclosed progress and discontinuation relating to the pulmonary fibrosis treatment and other products, the company reaffirmed that clinical trials for the refractory cancer treatment are continuing toward out-licensing. - FY2024-Q2WorsenedAnnual report
「In nucleic acid therapeutics drug discovery, the company received notice from Bristol Myers Squibb that it would not exercise its option to obtain an additional in-license following the results of the Phase 2 clinical trial for the pulmonary fibrosis treatment. The company also received notice from Bristol Myers Squibb that it would discontinue the Phase 2 clinical trial for the treatment of nonalcoholic steatohepatitis (NASH) under the exclusive license agreement with the company for formulations targeting liver fibrosis and liver cirrhosis. The company continues to work on clinical trials for the refractory cancer treatment toward out-licensing.」
The option to obtain an additional in-license for the pulmonary fibrosis treatment was not exercised, and the Phase 2 trial for the NASH indication of the liver fibrosis and liver cirrhosis-related formulation was also discontinued. Meanwhile, clinical trials for the refractory cancer treatment are continuing toward out-licensing. - FY2024-Q1RestatedAnnual report
「In nucleic acid therapeutics drug discovery, the company continues to pursue clinical trials and other activities toward out-licensing its pipeline.」
Regarding nucleic acid drug discovery, the company continues activities such as clinical trials toward out-licensing its pipeline. No new trial stage or agreement execution is disclosed. - FY2023AdvancedAnnual report
「In nucleic acid drug discovery, the company is analyzing the results of the Phase 2 clinical trial for pulmonary fibrosis and will proceed with negotiations for an out-licensing agreement.」
For the pulmonary fibrosis treatment, the company disclosed the next-stage commercialization activities of analyzing the Phase 2 clinical trial results and negotiating an out-licensing agreement. - FY2023-Q3RestatedAnnual report
「In nucleic acid therapeutics drug discovery, the company continues to work on clinical trials for treatments for pulmonary fibrosis and refractory cancers.」
The company continues to work on clinical trials for treatments for pulmonary fibrosis and refractory cancers. No new trial stage or completion is disclosed. - FY2023-Q2RestatedAnnual report
「In nucleic acid therapeutics drug discovery, the company continues to work on clinical trials for treatments for pulmonary fibrosis and refractory cancers.」
The company reaffirmed the continuation of clinical trials for treatments for pulmonary fibrosis and refractory cancers. No new trial stage or completion is disclosed. - FY2023-Q1RestatedAnnual report
「In nucleic acid therapeutics drug discovery, the company continues to work on clinical trials for treatments for pulmonary fibrosis and refractory cancers.」
Clinical trials for treatments for pulmonary fibrosis and refractory cancers are continuing. No new trial stage or completion is disclosed. - FY2022RestatedAnnual report
「In nucleic acid drug discovery, the company achieved the specified milestone under the exclusive license agreement for a formulation targeting liver fibrosis and liver cirrhosis during the first quarter of the consolidated fiscal period. It also continues to work on clinical trials for treatments for pulmonary fibrosis and refractory cancers.」
The company reaffirmed the achievement of the milestone for the formulation targeting liver fibrosis and liver cirrhosis and the continuation of clinical trials for treatments for pulmonary fibrosis and refractory cancers. - FY2022-Q3RestatedAnnual report
「The company continues to work on clinical trials for treatments for pulmonary fibrosis and refractory cancers.」
Clinical trials for treatments for pulmonary fibrosis and refractory cancers are continuing. - FY2022-Q2RestatedAnnual report
「In nucleic acid therapeutics drug discovery, the company achieved the specified milestone under the exclusive license agreement for a formulation targeting liver fibrosis and liver cirrhosis.」
For the formulation targeting liver fibrosis and liver cirrhosis, the company reaffirmed the achievement of the milestone under the license agreement disclosed in the previous quarter. - FY2022-Q1AdvancedAnnual report
「The company achieved the specified milestone under a license agreement in nucleic acid therapeutics drug discovery.」
For a formulation targeting liver fibrosis and liver cirrhosis, the company achieved the specified milestone under the exclusive license agreement. - FY2021-Q2RestatedAnnual report
「In nucleic acid therapeutics drug discovery, the company continues to conduct clinical trials for treatments for pulmonary fibrosis and refractory cancers.」
Clinical trials for treatments for pulmonary fibrosis and refractory cancers are continuing. No new trial stage or completion is disclosed. - FY2021-Q1RestatedAnnual report
「In nucleic acid therapeutics drug discovery, the company continues to conduct clinical trials for treatments for pulmonary fibrosis and refractory cancers.」
Clinical trials for treatments for pulmonary fibrosis and refractory cancers are continuing. No new trial stage or completion is disclosed. - FY2020RestatedAnnual report
「In nucleic acid therapeutics drug discovery, the company continues to conduct clinical trials for treatments for pulmonary fibrosis and refractory cancers.」
Clinical trials for treatments for pulmonary fibrosis and refractory cancers are continuing. - FY2020-Q3RestatedAnnual report
「In nucleic acid therapeutics drug discovery, the company continues to conduct clinical trials for treatments for pulmonary fibrosis and refractory cancers.」
The company continues to work on clinical trials for treatments for pulmonary fibrosis and refractory cancers. - FY2020-Q2RestatedAnnual report
「In nucleic acid therapeutics drug discovery, the company continues to conduct clinical trials for treatments for pulmonary fibrosis and refractory cancers.」
The company continues to work on clinical trials for treatments for pulmonary fibrosis and refractory cancers. - FY2020-Q1RestatedAnnual report
「In nucleic acid therapeutics drug discovery, the company continues to conduct clinical trials for treatments for pulmonary fibrosis and refractory cancers.」
The company continues to work on clinical trials for treatments for pulmonary fibrosis and refractory cancers. No new trial stage or completion is disclosed. - FY2019AdvancedAnnual report
「In nucleic acid therapeutics drug discovery, the company began working toward clinical trials for pulmonary fibrosis.」
The pulmonary fibrosis treatment progressed from preparations for clinical trials to the stage of beginning work on clinical trials. - FY2019-Q2RestatedAnnual report
「The company also continues to work toward clinical trials for pulmonary fibrosis as part of its nucleic acid therapeutics drug discovery activities.」
Efforts toward clinical trials for pulmonary fibrosis in nucleic acid therapeutics drug discovery are continuing. - FY2019-Q1RestatedAnnual report
「The company is also working toward clinical trials for a pulmonary fibrosis treatment as part of its nucleic acid therapeutics drug discovery activities.」
In nucleic acid therapeutics drug discovery, efforts toward clinical trials for pulmonary fibrosis are continuing. No new stage, such as the start of a clinical trial, is disclosed. - FY2018AdvancedAnnual report
「In nucleic acid therapeutics drug discovery, both the licensed liver cirrhosis treatment and the pulmonary fibrosis treatment being developed independently have entered the next clinical trial phase, marking steady progress.」
The disclosure states that both the liver cirrhosis treatment and the pulmonary fibrosis treatment have entered the next clinical trial phase, indicating progress in development. - FY2018-Q3RestatedAnnual report
「The drug discovery business using nucleic acid therapeutics has not been affected by the contract manufacturing business, and research and development will continue to create promising products following the liver cirrhosis treatment.」
The company states that it will continue research and development of drug discovery products following the liver cirrhosis treatment, separately from the deterioration of the contract manufacturing business. - FY2018-Q2RestatedAnnual report
「In the drug discovery business using nucleic acid therapeutics, research and development is continuing, centered on the base established on the U.S. West Coast last year, with the aim of creating products that will form the pipeline following the liver cirrhosis treatment.」
Research and development centered on the U.S. West Coast base is continuing to create a nucleic acid therapeutics pipeline following the liver cirrhosis treatment. No new milestones, such as the start of a trial or regulatory approval, are indicated. - FY2018-Q1RestatedAnnual report
「In the drug discovery business using nucleic acid therapeutics, resources are being invested to create products that will form the next pipeline following the liver cirrhosis treatment, which made significant progress last year.」
Investment of resources in creating a nucleic acid therapeutics pipeline following the liver cirrhosis treatment is continuing. No new progress regarding a specific trial stage or commercialization timing is disclosed. - FY2017RestatedAnnual report
「In addition, the company will work with Bristol Myers Squibb in the United States toward the early commercialization of a liver cirrhosis treatment using nucleic acid therapeutics.」
The company has reaffirmed its policy of seeking early commercialization through cooperation with Bristol Myers Squibb following the exclusive license agreement. - FY2017-Q3AdvancedAnnual report
「Regarding development of the organ fibrosis treatment, which has been pursued since 2008, an exclusive license agreement was signed with Bristol Myers Squibb in the United States covering the development, manufacture and sale of the treatment, with the aim of accelerating development and bringing it to market at an early stage.」
For the organ fibrosis treatment, an exclusive license agreement covering development, manufacturing and sales was signed, advancing the project to the stage of accelerating development and aiming for early commercialization. A US$100 million upfront payment was also recognized. - FY2017-Q2RestatedAnnual report
「For the organ fibrosis treatment using molecular-targeted DDS (drug delivery system) technology, which is being pursued from a medium- to long-term perspective, a Phase 2b trial is planned for the treatment of liver cirrhosis.」
The plan for a Phase 2b trial of the liver cirrhosis treatment continues to be disclosed. No new progress, such as the start or completion of the trial, is indicated. - FY2017-Q1AdvancedAnnual report
「For the organ fibrosis treatment using molecular-targeted DDS (drug delivery system) technology, which is being pursued from a medium- to long-term perspective, a Phase 2b trial is planned for the treatment of liver cirrhosis. In addition, an IND application (Investigational New Drug application) for the treatment of pulmonary fibrosis is scheduled during fiscal 2016, and development is progressing smoothly.」
A Phase 2b trial is planned for the treatment of liver cirrhosis, while an IND application for the treatment of pulmonary fibrosis is scheduled during fiscal 2016, providing greater detail on the target diseases and development stages. - FY2016First statedAnnual report
「The liver cirrhosis treatment using molecular-targeted DDS (drug delivery system) technology progressed smoothly. Clinical trials were initiated in Japan and Europe (Bulgaria), while in the United States, where development is furthest advanced, the product received Fast Track designation from the U.S. FDA (Food and Drug Administration) based on interim results.」
The disclosure states that clinical trials began in Japan and Europe and that the product received FDA Fast Track designation in the United States.