Opamtistomig granted NMPA priority review for extrapulmonary neuroendocrine carcinoma
- Sponsor
- Nanjing Leads Biolabs $9887.HK
- Drug
- opamtistomig
- Indication
- Advanced extrapulmonary neuroendocrine carcinoma (EP-NEC), monotherapy, in patients with disease progression following 2+ prior systemic therapy lines
NMPA's Center for Drug Evaluation admitted Leads Biolabs' BLA for opamtistomig (LBL-024, PD-L1/4-1BB bispecific antibody) to priority review as monotherapy for advanced EP-NEC in patients whose disease progressed on 2+ prior systemic therapy lines.
What this means
Opamtistomig is an experimental antibody from Nanjing Leads Biolabs that pairs two immunotherapy actions in one molecule: it blocks PD-L1 — a signal cancer cells use to hide from the immune system — while activating 4-1BB, which boosts tumor-fighting immune cells. China's drug regulator (NMPA) has moved the application into a faster review track, which shortens the review clock from 200 working days to 130. The indication is extrapulmonary neuroendocrine carcinoma (EP-NEC), a rare, aggressive cancer, and the population is patients whose disease has continued despite two or more prior therapies. This is a Chinese-market decision — no FDA action is currently being sought.