Maximizing the product value of CBP501 by expanding its indications
First written in FY2016. 12 of 26 entries say "Restated". Latest entry: 2026-10-14.
No other company in this theme has enough history to compare yet.
- 2026-10-14AdvancedShare Issuance and Disposal
「現在は、CBP501臨床第3相試験の開始承認申請を行い欧州規制当局EMAとの折衝を進める傍ら、開始承認を取得した後に迅速に試験を開始し進行させるための準備を進めており、臨床試験を実施する医療機関との契約等を先行して進めています。」
CBP501の膵臓がん第3相試験について、開始承認申請・規制当局との折衝に加え、医療機関との契約等の開始前準備を明示している。 - FY2026SoftenedAnnual report
「The company has completed a Phase 2 clinical trial of CBP501 in combination with an immune checkpoint inhibitor antibody for pancreatic cancer and is currently preparing for the next clinical trial phase.」
The disclosure states that the Phase 2 trial for pancreatic cancer has been completed and preparations for the next phase are under way, but the specific reference in the immediately preceding half-year filing to the application and preparations for a Phase 3 trial in Europe has been generalized. - 2026-06-30RestatedRevision of earnings forecasts
「The compound CBP501 had completed the Phase 2 clinical trial, received approval to initiate the U.S. Phase 2b trial, and was at the application stage for initiation of the European Phase 3 clinical trial,」
The Company reaffirmed CBP501's status in next-stage clinical development and at the application stage for initiation of the European Phase 3 trial. - FY2026-H1RestatedAnnual report
「Clinical trials of CBP501 are being conducted in combination with an immune checkpoint inhibitor antibody, and the company is currently at the submission and preparation stage for a Phase 3 clinical trial in Europe.」
Development of CBP501 in combination with an immune checkpoint inhibitor antibody and submissions and preparations for a Phase 3 trial in Europe are continuing. - FY2025-H1AdvancedAnnual report
「The company is currently pursuing regulatory submissions and preparations to initiate a Phase 3 clinical trial in Europe aimed at obtaining approval.」
Development of CBP501 for expanding its indications has advanced to the submission and preparation stage for launching a Phase 3 trial in Europe. - FY2024AdvancedAnnual report
「The company has completed a Phase 2 clinical trial of CBP501 in combination with an immune checkpoint inhibitor antibody for pancreatic cancer and is currently preparing for the next clinical trial phase.」
The company completed the combination Phase 2 trial of CBP501 for pancreatic cancer and advanced to the preparation stage for the next clinical trial related to expanding its indications. - FY2024-Q3AdvancedAnnual report
「The company is currently pursuing regulatory submissions and preparations to initiate a Phase 3 clinical trial in Europe aimed at obtaining approval.」
Development of CBP501 for expanding its indications and enhancing its product value has advanced to the regulatory submission and preparation stage for launching a Phase 3 trial in Europe. - FY2024-Q1RestatedAnnual report
「A Phase 2 clinical trial was conducted under U.S. FDA regulations in combination with an immune checkpoint inhibitor antibody for third-line pancreatic cancer treatment.」
Development of CBP501 in combination with an immune checkpoint inhibitor antibody for third-line pancreatic cancer treatment is continuing. - FY2023SoftenedAnnual report
「The company is currently conducting a Phase 2 clinical trial combining CBP501 with an immune checkpoint inhibitor antibody for pancreatic cancer while preparing for the next clinical trial phase.」
The filing describes the CBP501 Phase 2 trial for pancreatic cancer and preparations for the next phase, but does not explicitly mention the Phase 3 preparations or achievement of the primary endpoint stated in the previous quarter's filing. - FY2023-Q3RestatedAnnual report
「Under the regulatory oversight of the U.S. FDA, the company is conducting a Phase 2 clinical trial combining CBP501 with an immune checkpoint inhibitor antibody for third-line treatment of pancreatic cancer. In the three-drug combination arm, which included CBP501, the clinical trial achieved its primary endpoint, and the company decided to end the first stage early of the trial, which was designed in two stages. The company is currently preparing to start the Phase 3 clinical trial.」
The company has reconfirmed that the combination trial of CBP501 for third-line treatment of pancreatic cancer achieved its primary endpoint and progressed to preparations for the Phase 3 trial. - FY2023-Q2AdvancedAnnual report
「The trial achieved its primary endpoint in the three-drug combination arm including CBP501, and the Company decided to end the trial early after the first stage of its two-stage design. Preparations are currently under way to begin a Phase 3 clinical trial.」
The combination trial of CBP501 for third-line treatment of pancreatic cancer achieved its primary endpoint, ended the first stage early, and moved to preparations for the Phase 3 trial. - FY2023-Q1AdvancedAnnual report
「Under US FDA regulation, the Company is conducting a Phase 2 clinical trial combining CBP501 with an immune checkpoint inhibitor antibody for third-line treatment of pancreatic cancer. The trial has completed subject enrollment in the first stage of a two-stage design, and dosing and observation are continuing.」
In the CBP501 Phase 2 trial for third-line treatment of pancreatic cancer, the company completed enrollment for the first stage and moved to the dosing and observation stage. - FY2022RestatedAnnual report
「Based on the results of the CBP501 Phase 1b clinical trial using this approach, pancreatic cancer was selected as the target indication for the CBP501 Phase 2 clinical trial. The company is currently conducting a Phase 2 clinical trial to evaluate CBP501's efficacy, safety, and dosage and administration.」
The company has reconfirmed that pancreatic cancer was selected as a target indication for CBP501 and that a Phase 2 clinical trial is being conducted for that indication. - FY2022-Q3RestatedAnnual report
「The company is conducting a clinical trial combining CBP501 with an immune checkpoint inhibitor antibody and is currently in the early stage of the Phase 2 clinical trial.」
The company has reconfirmed that the Phase 2 clinical trial of CBP501 in combination with an immune checkpoint inhibitor antibody is being conducted in its early stage. - FY2022-Q2RestatedAnnual report
「The clinical trial is currently in its final stages, having completed dosing in the expansion phase, the second part of the trial, for pancreatic and colorectal cancer, and is awaiting receipt of the final report. In parallel, the Company has begun a Phase 2 clinical trial for pancreatic cancer.」
The company has reconfirmed that it advanced the expansion phase related to CBP501's indication expansion to the final stage and began a Phase 2 clinical trial for pancreatic cancer. - FY2022-Q1AdvancedAnnual report
「The clinical trial is currently in its final stages, having completed dosing in the expansion phase, the second part of the trial, for pancreatic and colorectal cancer, and is awaiting receipt of the final report. The subsequent Phase 2 clinical trial is under way.」
The company advanced the combination trial for pancreatic cancer and colorectal cancer to the final stage and began the next Phase 2 clinical trial related to indication expansion. - FY2021AdvancedAnnual report
「The company is advancing a clinical trial combining CBP501 with cisplatin and the immune checkpoint inhibitor antibody nivolumab, namely the Phase 1b expansion phase, while in parallel preparing for a Phase 2 clinical trial.」
The company advanced the combination trial for pancreatic cancer and other indications to the late stage and moved to the preparation stage for the Phase 2 clinical trial. - FY2021-Q3RestatedAnnual report
「With respect to CBP501's development, the company is currently in the late stage of the Phase 1b expansion phase, having completed dosing, and is actively conducting alliance activities to secure strategic partnerships with pharmaceutical companies and others.」
The company has advanced CBP501's expansion phase to the late stage and continues alliance activities to secure a strategic partnership. - FY2021-Q2AdvancedAnnual report
「The clinical trial is currently in its final stages, having completed dosing in the expansion phase, the second part of the trial, for pancreatic and colorectal cancer, and preparations are under way for the next clinical trial.」
The company completed dosing in the expansion phase for pancreatic cancer and colorectal cancer and progressed to the late stage of the trial for indication expansion. - FY2021-Q1AdvancedAnnual report
「With respect to CBP501's development, the company is currently in the late stage of the Phase 1b expansion phase, having completed enrollment, and is actively conducting alliance activities to secure strategic partnerships with pharmaceutical companies and others.」
The company completed enrollment in the Phase 1b expansion phase for CBP501's indication expansion and progressed to the late stage. - FY2020RestatedAnnual report
「After completing the first half of the Phase 1b trial during 2018, the company is currently conducting an "expansion-phase" trial focused on pancreatic cancer and colorectal cancer based on the results of that trial.」
The company has reconfirmed that it is conducting an expansion-phase trial in pancreatic cancer and colorectal cancer to expand CBP501's indications. - FY2020-Q3RestatedAnnual report
「The clinical trial is currently in its second half, the expansion phase, in pancreatic cancer and colorectal cancer.」
The company has reconfirmed that it is conducting the expansion phase in pancreatic cancer and colorectal cancer to expand CBP501's indications. - FY2020-Q2RestatedAnnual report
「The clinical trial is currently in its second half, the expansion phase, in pancreatic cancer and colorectal cancer.」
The company has reconfirmed that it is conducting the expansion phase in pancreatic cancer and colorectal cancer to expand CBP501's indications. - FY2020-Q1RestatedAnnual report
「During the second quarter accounting period of the fiscal year ending June 2019, the company completed the dose-escalation phase, the first half of the Phase 1b trial. After reviewing the results, it started the expansion phase, the second half of the trial, in pancreatic cancer and colorectal cancer.」
The company has reconfirmed that CBP501's expansion phase is being conducted in pancreatic cancer and colorectal cancer. - FY2019AdvancedAnnual report
「After completing the first half of the Phase 1b trial during 2018, the company is currently conducting an "expansion-phase" trial focused on pancreatic cancer and colorectal cancer based on the results of that trial.」
For CBP501, the company has explicitly stated that the expansion-phase trial is being conducted in pancreatic cancer and colorectal cancer. - FY2016First statedAnnual report
「To maximize revenue through early expansion of indications, the company will seek to collect data on efficacy in indications other than these target cancers and actively promote development related to expanding CBP501's indications.」
The company has set revenue maximization through expansion into indications other than malignant pleural mesothelioma and non-small-cell lung cancer as a goal.