Announced details
Third-line treatment for pancreatic cancer, other cancer immunotherapy indications, solid tumors and hematological cancers. Future expansion of CBP501's indications is also contemplated.
The primary endpoint of the 3-month progression-free survival rate was achieved in the Phase 2 clinical trial of CBP501.
CBP501 achieved its primary endpoint in a Phase 2 clinical trial. CBS9106 completed a Phase 1 clinical trial.
The licensing partnership with Stemline was terminated, and all rights relating to the development and commercialization of CBS9106 were returned to the Company in June 2025. The Company conducts joint research with the University of Shizuoka. The Company conducts joint research on AI-based drug discovery with INTAGE Healthcare.
Stemline is the partner for CBS9106. The University of Shizuoka is a joint research partner for the IDO/TDO dual inhibitor. INTAGE Healthcare is a joint research partner for AI-based drug discovery. Pharma Valley Center is involved in alliance activities. EMA and FDA are regulatory authorities. Other details are Not disclosed.
CBP501 orphan drug designation
European regulatory authorities (EMA)
The materials refer to 10 years of exclusivity protection in Europe and 7 years in the United States in connection with the orphan drug designation. The registration number is Not disclosed.
2-2-1 Otemachi, Numazu, Shizuoka, Japan
Upfront payments for CBS9106 were ¥10 million in December 2014 and ¥5 million in August 2018. Technology advisory fees totaled ¥702 million from December 2014 through June 2021.
The estimated monthly drug cost for CBP501 is approximately US$20,000 in the United States and €9,000–€10,000 in Europe. Both figures are estimates following commercialization.
No business revenue was recorded for the first 3 quarters of the fiscal year ending June 2026. The operating loss was ¥916 million, while the ordinary loss and net loss were each ¥873 million. The cost of the CBP501 Phase 3 clinical trial is expected to be ¥4.5–¥5.0 billion, creating short-term funding requirements.
European Journal of Cancer
European Society for Medical Oncology (ESMO)
GLOBOCAN2018（IARC）
ECIS European Cancer Information System Globocan 2022
NCCN Clinical Practice Guidelines in Oncology
The International Agency for Research on Cancer（IARC）
| Item | Details |
|---|---|
| Names of Products / Services Covered | CBP501, CBT005, CBS9106（Felezonexor）, CBP-A08, IDO/TDO dual inhibitor |
| Counterparty | Stemline, Shizuoka Prefectural University, INTAGE Healthcare, Pharma Valley Center, European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA) |
| Counterparty overview | Stemline is the partner for CBS9106. The University of Shizuoka is a joint research partner for the IDO/TDO dual inhibitor. INTAGE Healthcare is a joint research partner for AI-based drug discovery. Pharma Valley Center is involved in alliance activities. EMA and FDA are regulatory authorities. Other details are Not disclosed. |
| Relationship with the Company | The licensing partnership with Stemline was terminated, and all rights relating to the development and commercialization of CBS9106 were returned to the Company in June 2025. The Company conducts joint research with the University of Shizuoka. The Company conducts joint research on AI-based drug discovery with INTAGE Healthcare. |
| Contract Value | Upfront payments for CBS9106 were ¥10 million in December 2014 and ¥5 million in August 2018. Technology advisory fees totaled ¥702 million from December 2014 through June 2021. |
| Offering price | The estimated monthly drug cost for CBP501 is approximately US$20,000 in the United States and €9,000–€10,000 in Europe. Both figures are estimates following commercialization. |
| Contract Date | The CBS9106 out-licensing agreement was concluded in December 2014, and the territory was expanded in August 2018. The agreement was terminated in June 2025. |
| Applicable area | Third-line treatment for pancreatic cancer, other cancer immunotherapy indications, solid tumors and hematological cancers. Future expansion of CBP501's indications is also contemplated. |
| Award/certification name | CBP501 orphan drug designation |
| Awarding / certifying body | European regulatory authorities (EMA) |
| Registration number and expiry date | The materials refer to 10 years of exclusivity protection in Europe and 7 years in the United States in connection with the orphan drug designation. The registration number is Not disclosed. |
| Location | 2-2-1 Otemachi, Numazu, Shizuoka, Japan |
| Location scale | 19 employees (14 in research and development and 5 in administration). |
| Quantitative Effects | The primary endpoint of the 3-month progression-free survival rate was achieved in the Phase 2 clinical trial of CBP501. |
| Usage history | CBP501 achieved its primary endpoint in a Phase 2 clinical trial. CBS9106 completed a Phase 1 clinical trial. |
| Impact on Business Performance | No business revenue was recorded for the first 3 quarters of the fiscal year ending June 2026. The operating loss was ¥916 million, while the ordinary loss and net loss were each ¥873 million. The cost of the CBP501 Phase 3 clinical trial is expected to be ¥4.5–¥5.0 billion, creating short-term funding requirements. |
| Source | European Journal of Cancer, European Society for Medical Oncology (ESMO), GLOBOCAN2018（IARC）, ECIS European Cancer Information System Globocan 2022, NCCN Clinical Practice Guidelines in Oncology, The International Agency for Research on Cancer（IARC） |
Items this document does not state (1)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.To reflect the third-quarter results and explain progress in the application and preparations to initiate the CBP501 Phase 3 clinical trial in Europe, the development status of subsequent pipelines, and future funding requirements and financial policies.