China’s Center for Drug Evaluation has accepted opamtistomig for previously treated advanced EP-NEC and placed the application under Priority Review, while detailed pivotal data await presentation.
Nanjing Leads Biolabs Co., Ltd. has secured priority review in China for the biologics licence application covering opamtistomig as a monotherapy for advanced extrapulmonary neuroendocrine carcinoma after at least two previous systemic treatment lines. The July 10, 2026 decision moves the Hong Kong-listed biotechnology company, traded under stock code 9887, closer to a possible first
EP-NEC has no approved drug worldwide. Leads Biolabs now has to prove Opamtistomig can turn rare-tumor urgency into regulatory momentum.