Oncolys BioPharma Inc. [4588.T]
TOKYO, May 22 (Pulse News Wire) – Oncolys BioPharma Inc. (4588.T) received unconditional approval from the Ministry of Health, Labour and Welfare's Pharmaceutical Affairs Council meeting held on May 22, 2026.
The council approved the telomeric acid injection for treating esophageal cancer unsuitable for curative surgery or chemoradiotherapy. Key points from the approval include: - Full approval without conditional restrictions. - Indicated for patients with unresectable esophageal cancer ineligible for curative surgery or chemoradiotherapy.
- Orphan drug designation grants a ten-year re-examination period. - Post-marketing surveillance plans involve monitoring 85 cases through comprehensive case studies. Following formal regulatory processes, sales of Telomerisin injection are expected to commence in December 2026, aligning with the company’s initial timeline.
The approval does not impact the company’s financial statements.
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