Core Product Velyso Granted Orphan Drug Designation in Japan
September 29, 2026
Source: drugdu
30
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
By editor
Copyright©2026 Ddu. All rights reserved.
Read more on
- Novo Nordisk and Nanexa Ink Up to €1.165B Long-Acting Delivery Deal for Obesity and Diabetes September 29, 2026
- siRNA Biotech ADARx Raises $446M in 2026’s Third-Largest Biotech IPO September 29, 2026
- Merck and Eisai’s Welireg Plus Lenvima Approved by FDA for Previously Treated Advanced Kidney Cancer September 29, 2026
- Mirum and Incyte’s Atebrioz Wins FDA Approval for Rare Bone Disorder FOP September 29, 2026
- J&J in Talks to Sell DePuy Synthes to Apollo September 29, 2026
your submission has already been received.
OK
Subscribe
Please enter a valid Email address！
Submit
The most relevant industry news & insight will be sent to you every two weeks.
