Core Product Velyso Granted Orphan Drug Designation in Japan
September 29, 2026
Source: drugdu
31
On September 28, Leads Biolabs-B (09887) announced that its core product Velyso® (opatidijumimab, a PD-L1/4-1BB bispecific antibody) has been granted orphan drug designation by the Japanese Ministry of Health, Labour and Welfare for the treatment of extrapulmonary neuroendocrine carcinoma (EP-NEC).
This is the third orphan drug designation that Velyso® has received, following those from the U.S. Food and Drug Administration and the European Commission, marking a further expansion of its global regulatory recognition into major Asian markets.
Source: https://finance.eastmoney.com/a/202609283885132814.html
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