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Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- Jan 16
- 1 min read
14/01/2026
Nanjing Leads Biolabs' opamtistomig received the FDA fast track designation for extra-pulmonary neuroendocrine carcinoma (Ref)
The US FDA granted fast track designation to Nanjing Leads Biolabs' opamtistomig (LBL-024; PD-L1 x 4-1BB bispecific antibody) for the treatment of extra-pulmonary neuroendocrine carcinoma (EP-NEC).
Dr. Charles Cai, CMO, Leads Biolabs: “With Opamtistomig now receiving Fast Track Designation from the FDA—following Breakthrough Therapy Designation in China and Orphan Drug Designation in the United States—we have achieved a rare triple regulatory acceleration. This milestone reflects strong regulatory confidence in the molecule’s clinical potential and will meaningfully accelerate global development, shorten approval timelines, and help bring this innovative therapy to patients with high unmet needs worldwide."
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