Medigene Biotech and Oncolys BioPharma’s Oncolytic Virus OBP-301 (Telomelysin) Secures Official Marketing Approval from Japan’s MHLW

Medigene Biotech (基亞生物科技; 3176 TT) announced that the oncolytic virus therapeutic OBP-301 (Telomelysin), co-developed with its Tokyo-listed strategic partner Oncolys BioPharma (4588 TYO), was officially granted manufacturing and marketing approval by Japan's Ministry of Health, Labour and Welfare (MHLW). The approved indication is designated for "Esophageal cancer unsuitable for curative resection or chemoradiotherapy." Because OBP-301 previously secured Orphan Drug Designation from Japanese regulatory authorities, the asset is legally granted a 10-year period of market exclusivity in Japan.