Nanjing Leads Biolabs cancer drug gets priority review in China
China's National Medical Products Administration (NMPA) has granted priority review for Nanjing Leads Biolabs' Opamtistomig, a PD-L1/4-1BB bispecific antibody for advanced extrapulmonary neuroendocrine carcinoma (EP-NEC).
Nanjing Leads Biolabs Co., Ltd. announced that China's National Medical Products Administration (NMPA) has accepted its biologics license application (BLA) for Opamtistomig for priority review. The drug is intended as a monotherapy for advanced extrapulmonary neuroendocrine carcinoma (EP-NEC).
The drug, a PD-L1/4-1BB bispecific antibody, targets a cancer type for which there are no globally approved treatments after initial therapies fail. EP-NEC is described as an aggressive, immune-cold tumor.
The priority review designation is expected to shorten the review timeline to 130 working days, compared to the standard 200 days. This accelerates the path to potential commercialization, and the company is actively preparing for launch.
Opamtistomig is designed to simultaneously block PD-L1 immune suppression and activate the 4-1BB co-stimulatory receptor. Leads Biolabs stated the drug has demonstrated potential in multiple cancer types and has received other designations, including Orphan Drug Designation from the U.S. FDA and European Commission for EP-NEC treatment.