Notice of the Outcome of the Regenerative Medical Products and Biologically Derived Technologies Subcommittee of the Pharmaceutical Affairs Council Regarding Marketing Approval for the Oncolytic Virus Telomelysin Injection
Oncolys BioPharma Inc.
Oncolytic virus Telomelysin injection
The product has been designated as an orphan drug (stated as the reason for setting the re-examination period at 10 years).
No impact (this announcement will have no impact on the Company’s financial results.)
This announcement will have no impact on the Company’s financial results.
Related procedures
Deliberation and approval by the Regenerative Medical Products and Biologically Derived Technology Committee of the Pharmaceutical Affairs and Food Sanitation Council
Ministry of Health, Labour and Welfare; Regenerative Medical Products and Biologically Derived Technology Committee of the Pharmaceutical Affairs and Food Sanitation Council
Company response
A post-marketing survey is planned using an all-case surveillance system, with 85 planned cases.
Following the product’s passage through the committee, Telomelysin injection is expected to go through the formal approval and NHI drug price listing processes before sales begin. The Company plans to begin sales of Telomelysin injection as scheduled in the fiscal year ending December 2026.
| Item | Details |
|---|---|
| Event name | Notice of the Outcome of the Regenerative Medical Products and Biologically Derived Technologies Subcommittee of the Pharmaceutical Affairs Council Regarding Marketing Approval for the Oncolytic Virus Telomelysin Injection |
| Date of occurrence | 21 May 2026 (committee meeting date) |
| Subject Entity | Oncolys BioPharma Inc. |
| Target Locations / Products | Oncolytic virus Telomelysin injection |
| Cause | The product has been designated as an orphan drug (stated as the reason for setting the re-examination period at 10 years). |
| Amount of Impact on Business Performance | No impact (this announcement will have no impact on the Company’s financial results.) |
| Impact on Earnings Forecast | This announcement will have no impact on the Company’s financial results. |
| Type of litigation or proceeding | Deliberation and approval by the Regenerative Medical Products and Biologically Derived Technology Committee of the Pharmaceutical Affairs and Food Sanitation Council |
| Court or authority | Ministry of Health, Labour and Welfare; Regenerative Medical Products and Biologically Derived Technology Committee of the Pharmaceutical Affairs and Food Sanitation Council |
| Date of filing / date of action | 21 May 2026 (committee meeting date) |
| Investigation structure | A post-marketing survey is planned using an all-case surveillance system, with 85 planned cases. |
| Outlook | Following the product’s passage through the committee, Telomelysin injection is expected to go through the formal approval and NHI drug price listing processes before sales begin. The Company plans to begin sales of Telomelysin injection as scheduled in the fiscal year ending December 2026. |
Items this document does not state (13)
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.As the product has been designated as an orphan drug, the re-examination period will be 10 years.