Initiation of company-led clinical trials from 2025 onward
First written in FY2024-Q2. 6 of 9 entries say "Advanced", first in FY2025. Latest entry: 2026-08-13.
No other company in this theme has enough history to compare yet.
- FY2026AdvancedAnnual report
「The Company is steadily preparing to begin clinical trials in Japan, including preparations for commercial-scale manufacturing in compliance with international manufacturing standards (GMP) to ensure the quality and safety of pharmaceuticals, following trial manufacturing of the clinical trial product.」
For the GCT-103 clinical trial in Japan, preparations progressed from trial manufacturing to the stage of preparing for GMP commercial-scale manufacturing under a structure in which Mochida Pharmaceutical Co.,Ltd. is responsible for the clinical trial and S-Quatre for manufacturing. - 2026-05-14AdvancedEarnings presentation materials
「SQ independently held a pre-IND meeting with the US FDA and obtained agreement and advice concerning the manufacture of the investigational product, nonclinical studies and the clinical trial plan.」
GCT-103 advanced to a pre-IND meeting with the FDA in preparation for a US-sponsored clinical trial. - FY2026-H1AdvancedAnnual report
「For the allogeneic SQ-SHED for cerebral palsy (the Company's development code: GCT-103), preparations are under way to begin clinical trials in Japan under the joint commercialization agreement concluded with Mochida Pharmaceutical Co.,Ltd. in March 2025, with Mochida Pharmaceutical Co.,Ltd. mainly responsible for the clinical trial and related activities and S-Quatre mainly responsible for manufacturing and related activities. For overseas clinical trials, the Company held a Pre-IND Meeting with the US FDA (Food and Drug Administration) in October 2025.」
For GCT-103, preparations for a clinical trial in Japan, with Mochida Pharmaceutical Co.,Ltd. responsible for the trial and S-Quatre for manufacturing, progressed to a Pre-IND Meeting with the US FDA. - FY2025AdvancedAnnual report
「For the allogeneic SQ-SHED targeting this disease in Japan and using the MCB already established (the Company's development code: GCT-103), the Company concluded a joint commercialization agreement with Mochida Pharmaceutical Co.,Ltd. in March 2025. Going forward, Mochida Pharmaceutical Co.,Ltd. will mainly be responsible for the clinical trial and related activities, while the Company's group will mainly be responsible for manufacturing the SQ-SHED and related activities, and the parties will jointly advance development.」
The development structure has been formalized under the joint commercialization agreement with Mochida Pharmaceutical Co.,Ltd., with Mochida Pharmaceutical Co.,Ltd. responsible for the clinical trial and the Company's group responsible for manufacturing, rather than the previously anticipated company-sponsored trial led by the Company. - FY2025-H1ReframedAnnual report
「The clinical trial is expected to be led by the development partner. Discussions are under way to conclude an agreement with the development partner during the current consolidated fiscal year (the fiscal year ending March 2025) and to have the development partner submit the clinical trial notification during fiscal 2025 (the fiscal year ending March 2026).」
The plan was revised from a company-sponsored clinical trial led by the Company to a trial expected to be led by a development partner, with a specific timeline of concluding the agreement during the fiscal year ending March 2025 and submitting the clinical trial notification during the fiscal year ending March 2026. - FY2024-Q3RestatedAnnual report
「The Company will intensify discussions with development partners while looking ahead to Company-led clinical trials planned to begin in or after 2025.」
In preparation for company-sponsored clinical trials led by the Company from 2025 onward, the Company has reaffirmed its plan to intensify discussions with development partners. - FY2024-Q2First statedAnnual report
「The Company will intensify discussions with development partners while looking ahead to Company-led clinical trials planned to begin in or after 2025.」
Regarding SHED, the Company has for the first time explicitly stated its plan to begin Company-led clinical trials in or after 2025. It positions negotiations on contracts with development partners as a means of preparing for those clinical trials.