Termination of the SB623 Japanese ischemic stroke license agreement with Teijin and in-house development in Japan
First written in FY2018. 12 of 15 entries say "Restated". Latest entry: FY2027-H1.
0 other companies' latest entry also says "Restated".
- FY2027-H1RestatedAnnual report
「In Japan, we also plan to hold discussions with the Pharmaceuticals and Medical Devices Agency (PMDA) regarding ischemic stroke and are advancing preparations to begin clinical trials.」
Regarding domestic development of SB623 for chronic ischemic stroke, which the company is pursuing independently following termination of the agreement with TEIJIN LIMITED, the policy of scheduling consultations with the PMDA and advancing preparations to launch clinical trials has been reconfirmed. - FY2026RestatedAnnual report
「In Japan, during the current fiscal year, we aim to begin discussions with the Pharmaceuticals and Medical Devices Agency (PMDA) in preparation for clinical trials for the SB623 chronic-phase ischemic stroke program.」
Regarding the domestic chronic ischemic stroke program, which the company is pursuing independently following termination of the agreement with TEIJIN LIMITED, the policy of aiming to begin consultations with the PMDA has been reconfirmed. - FY2024-Q3RestatedAnnual report
「For the SB623 chronic stroke programme, the Company will advance efforts to launch a clinical trial in Japan based on the additional analysis results from the US Phase IIb clinical trial, which failed to meet its primary endpoint and involved 163 subjects, promptly after obtaining approval for the domestic SB623 chronic traumatic brain injury programme.」
Regarding domestic development of SB623 for chronic ischemic stroke, which the company is pursuing independently following termination of the agreement with TEIJIN LIMITED, the policy of advancing efforts to launch domestic clinical trials after obtaining approval has been reconfirmed. - FY2024-Q2RestatedAnnual report
「For the SB623 chronic stroke programme, the Company will advance efforts to launch a clinical trial in Japan based on the additional analysis results from the US Phase IIb clinical trial, which failed to meet its primary endpoint and involved 163 subjects, promptly after obtaining approval for the domestic SB623 chronic traumatic brain injury programme.」
Regarding domestic development of the chronic ischemic stroke program, which the company is pursuing independently following termination of the agreement with TEIJIN LIMITED, the policy of advancing efforts to launch clinical trials after obtaining approval has been reconfirmed. - FY2024-Q1SoftenedAnnual report
「For the SB623 chronic stroke programme, the Company will advance efforts to launch a clinical trial in Japan based on the additional analysis results from the US Phase IIb clinical trial, which failed to meet its primary endpoint and involved 163 subjects, promptly after obtaining approval for the domestic SB623 chronic traumatic brain injury programme.」
Regarding domestic development of the chronic ischemic stroke program, which the company is pursuing independently following termination of the agreement with TEIJIN LIMITED, the timing of efforts to launch clinical trials was indicated as being after approval is obtained for the domestic SB623 chronic traumatic brain injury program. - FY2023RestatedAnnual report
「For the SB623 chronic stroke programme, the Company is advancing efforts to launch a clinical trial in Japan based on the additional analysis results from the US Phase IIb clinical trial, which failed to meet its primary endpoint and involved 163 subjects.」
Regarding domestic development of SB623 for chronic ischemic stroke, which the company is pursuing independently following termination of the agreement with TEIJIN LIMITED, efforts toward launching domestic clinical trials are continuing. - FY2023-Q3RestatedAnnual report
「For the SB623 chronic stroke programme, the Company is advancing efforts to launch a clinical trial in Japan based on the additional analysis results from the US Phase IIb clinical trial, which failed to meet its primary endpoint and involved 163 subjects.」
Regarding domestic development of SB623 for chronic ischemic stroke, which the company is pursuing independently following termination of the agreement with TEIJIN LIMITED, the policy of advancing efforts toward launching domestic clinical trials has been reconfirmed. - FY2023-Q1RestatedAnnual report
「For the SB623 chronic stroke programme, the Company is advancing efforts to launch a clinical trial in Japan based on the additional analysis results from the US Phase IIb clinical trial, which failed to meet its primary endpoint and involved 163 subjects.」
Regarding domestic development of SB623 for chronic ischemic stroke, which the company is pursuing independently following termination of the agreement with TEIJIN LIMITED, the policy of advancing efforts toward launching domestic clinical trials has been reconfirmed. - FY2022-Q2RestatedAnnual report
「Going forward, in order to maximize the value of SB623 through the selective allocation and concentration of management resources, the company will prioritize preparations for domestic development of the ischemic stroke and intracerebral hemorrhage programs in parallel with preparations for filing a domestic marketing authorization application for SB623 for chronic traumatic brain injury as soon as possible.」
The policy of allocating resources to prioritize domestic development of the SB623 ischemic stroke and intracerebral hemorrhage programs in parallel with preparations for the domestic marketing authorization application has been reconfirmed. - FY2021-Q2ReframedAnnual report
「Going forward, in order to maximize the value of SB623 through the selective allocation and concentration of management resources, the company will prioritize domestic development of the ischemic stroke and intracerebral hemorrhage programs in parallel with preparations for filing a domestic marketing authorization application for SB623 for chronic traumatic brain injury during the current fiscal year」
The company indicated that development resources would be focused on prioritizing domestic development of the ischemic stroke and intracerebral hemorrhage programs in parallel with preparations for the domestic marketing authorization application for SB623 for chronic traumatic brain injury. - FY2020RestatedAnnual report
「In Japan, we entered into an agreement with TEIJIN LIMITED in 2009 concerning the development and sales rights for SB623 for ischemic stroke, but agreed to terminate the agreement effective 14 February 2018. Going forward, the company plans to advance development of the program in Japan.」
Following termination of the agreement with TEIJIN LIMITED, the policy of developing the SB623 ischemic stroke program in Japan independently has been reconfirmed. - FY2019RestatedAnnual report
「In Japan, we entered into an agreement with TEIJIN LIMITED in 2009 concerning the development and sales rights for SB623 for ischemic stroke, but agreed to terminate the agreement effective 14 February 2018. Going forward, the company plans to advance development of the program in Japan.」
Following termination of the agreement with TEIJIN LIMITED, the policy of developing the chronic ischemic stroke program in Japan independently has been reconfirmed. - FY2019-Q3RestatedAnnual report
「In parallel, preparations are currently under way for the Group to develop the program in Japan independently, and it aims to bring the treatment to market for chronic ischemic stroke earlier than anywhere else in the world.」
Following termination of the agreement with TEIJIN LIMITED, the policy of preparing to develop the domestic chronic ischemic stroke program independently has been reconfirmed. - FY2019-Q2RestatedAnnual report
「With respect to development of the program in Japan, although we entered into an exclusive license agreement with TEIJIN LIMITED in 2009 covering development and sales, the two companies agreed to terminate the agreement effective 14 February 2018. As a result, the rights to the program in Japan were returned to the Group, which is preparing to proceed with development independently and aims to bring the treatment to market for chronic ischemic stroke earlier than anywhere else in the world.」
Following termination of the agreement with TEIJIN LIMITED, the policy of returning the rights to the domestic chronic ischemic stroke program to the company and preparing for independent development has been reconfirmed. - FY2018First statedAnnual report
「Although we entered into an exclusive license agreement with TEIJIN LIMITED in 2009 covering the development and sale of the product, the two companies agreed to terminate the agreement effective 14 February 2018. As a result, the rights to the program in Japan were returned to the Group, and the Group will undertake development in Japan for chronic ischemic stroke as an indication.」
The policy of mutually terminating the exclusive license agreement with TEIJIN LIMITED for SB623 in chronic ischemic stroke in Japan, returning the domestic rights to the company and transitioning to development on its own, was first documented in the thread.