-+ 0.00%
-+ 0.00%
-+ 0.00%

Virishibo-B (09887): Verisin™ (PD-L1/4-1BB bispecific antibody opatisumimab, LBL-024) was included in the priority review and approval process for the treatment of advanced extrapulmonary neuroendocrine cancer

Zhitongcaijing·07/10/2026 04:41:04
Listen to the news

Zhitong Finance App News, Weilizhibo-B (09887) announced that Velisin™ (PD-L1/4-1BB bispecific antibody opatisumimab, LBL024) biological product marketing license application (BLA) for treating advanced extrapulmonary neuroendocrine cancer has been approved by the National Drug Administration (NMPA) Drug Evaluation Center (CDE) of the People's Republic of China for inclusion in the priority review and approval process. This BLA report is based on the positive results of a key registered clinical study led by Professor Shen Lin of Beijing Cancer Hospital to evaluate the efficacy and safety of Velisin™ in advanced EP-NEC patients who have previously received second-line or higher systematic treatment.

According to relevant Chinese regulations, the time limit for BLA review to be included in the priority review and approval process is 130 working days, while the regular review process is 200 working days. The inclusion of Verisign™ in the priority review process marks an important milestone towards commercialization, providing clear guidance and certainty about its expected approval schedule. The Company is actively promoting relevant pre-listing commercialization preparations.