Oncolys BioPharma Gains Full Japanese Approval for Esophageal Cancer Therapy
Oncolys BioPharma (TYO:4588) has received full marketing approval from Japan's Ministry of Health, Labour and Welfare for Telomelysin Injection to treat esophageal cancer patients ineligible for curative resection or chemoradiotherapy.It is the world's first oncolytic adenovirus product approved for this indication, based on data from a domestic pivotal study, according to a Tokyo bourse filing on Monday.The therapy selectively replicates in and destroys cancer cells by leveraging telomerase activity, offering a new option for patients with limited alternatives.Under a 2024 agreement, FUJIFILM Toyama Chemical will handle commercialization in Japan after NHI price listing.Oncolys will receive a milestone payment from its partner, recorded as revenue for fiscal 2026, with additional product supply payments recognized progressively after launch.The company plans to launch Telomelysin in Japan later this year and is currently assessing the approval's financial impact.
