China’s National Medical Products Administration (NMPA) has granted priority review status to the Biologics License Application (BLA) for Opamtistomig (LBL-024), an investigational PD-L1/4-1BB bispecific antibody developed by Leads Biolabs, for the treatment of advanced extrapulmonary Neuroendocrine Carcinoma (EP-NEC).

The application, accepted under the Center for Drug Evaluation (CDE) priority review and approval procedure, is supported by results from a pivotal registrational clinical study led by Professor Shen Lin of Peking University Cancer Hospital. The study evaluated the safety and efficacy of Opamtistomig as a monotherapy in patients with advanced EP-NEC whose disease had progressed after two or more prior lines of systemic therapy.

Under China's priority review mechanism, the regulatory review period is reduced to 130 working days, compared with 200 working days under the standard review process. The designation is expected to accelerate the evaluation of the therapy and support preparations for potential commercialisation.

According to the company, Opamtistomig is being investigated across multiple tumour types, with EP-NEC representing its lead indication. The programme also includes clinical development in Non-Small Cell Lung Cancer (NSCLC) and Biliary Tract Cancer (BTC).

EP-NEC is a rare and highly aggressive cancer with limited treatment options following failure of platinum-based chemotherapy. Currently, no therapy has been approved globally for this indication, and later-line treatments have demonstrated low response rates and limited survival benefits, highlighting a significant unmet medical need.

Leads Biolabs stated that it will continue working closely with Chinese regulators during the review process while advancing preparations for the potential launch of the therapy.