Oncolys BioPharma Inc. [4588.T]
TOKYO, Jun 08 (Pulse News Wire) – Oncolys BioPharma Inc. (4588.T) secured approval from the Ministry of Health, Labour and Welfare for its tumor-dissolving virus Therapine injection (generic name: Slatactrebev, development code: OBP-301) on June 08, 2026.
The drug targets esophageal cancer patients ineligible for curative surgery or chemoradiotherapy. Therapine injection becomes the world's first approved treatment specifically targeting esophageal cancer through a tumor-dissolving virus. Based on results from a Phase II trial conducted across 17 domestic facilities, Oncolys submitted the application on December 15, 2025. The approval received is unconditional and does not come with any conditions or time limits. Fuji Pharma Toyama Chemical Co., Ltd. will handle sales post-price inclusion according to a distribution agreement signed in February 2024.
This milestone achievement enables Oncolys to contribute significantly to esophageal cancer treatment by offering a novel therapeutic option. As part of the deal, Oncolys expects to receive milestone payments from Fuji Pharma Toyama Chemical, which will be recorded in the fiscal year ending December 2026. Additionally, remaining advance payments related to product fees will also be collected during the same period. These advances are currently recorded as contract liabilities on the balance sheet and will be recognized as revenue upon the launch of Therapine injection sales. Oncolys plans to commence sales of Therapine injection in the fiscal year beginning December 2026, following price inclusion. An assessment of the impact on the current fiscal performance is ongoing.
🟢 Confidence: High AI-translated content.