HK Stock Market Move | LEADS BIOLABS-B(09887) rose more than 5%, ViLeX was included in the priority review and approval process for the treatment of advanced pulmonary neuroendocrine cancer.

LEADS BIOLABS-B (09887) rose over 5%, as of the time of writing, it had risen 3.78% to 50.25 Hong Kong dollars, with a turnover of 75.6047 million Hong Kong dollars. On the news front, at noon on July 10, LEADS BIOLABS-B announced that the biopharmaceutical product, Opatrisumab monoclonal antibody (PD-L1/4-1BB bispecific antibody, LBL024), for the monotherapy of advanced pulmonary extrapulmonary neuroendocrine carcinomas has submitted a Biologics License Application (BLA) and has been approved by the National Medical Products Administration (NMPA) Drug Evaluation Center (CDE) of the People's Republic of China for priority review and approval. This BLA application is based on positive results from a key registration clinical study led by Professor Shen Lin of the Beijing Cancer Hospital, aiming to evaluate the efficacy and safety of Opatrisumab in patients with advanced EP-NEC who have progressed after receiving second-line or higher systemic treatment. According to relevant Chinese regulations, the review time for BLA applications included in the priority review and approval process is 130 working days, while the regular review process is 200 working days. The inclusion of Opatrisumab in the priority review process marks an important milestone in its path to commercialization, providing a clear guideline and certainty for its expected approval timeline. The company is actively advancing related pre-commercialization preparations.