LEADS BIOLABS-B (09887) rose more than 4% in morning trading. As of the time of writing, the stock was up 3.21% to HK$64.35, with a turnover of HK$8.9751 million.

On the news front, on May 19, LEADS BIOLABS-B announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has approved the initiation of a confirmatory Phase III clinical study. This study will evaluate Velishen™ (the PD-L1/4-1BB bispecific antibody Opatisumimab, LBL-024) in combination with platinum-based chemotherapy as a first-line treatment for patients with advanced extrapulmonary neuroendocrine carcinoma (EP-NEC).

This approval signifies a successful advancement in the clinical development of Opatisumimab for EP-NEC, moving from later-line monotherapy to first-line combination therapy. Previously, Opatisumimab had received CDE approval to conduct a single-arm pivotal registration clinical study for patients with third-line or later EP-NEC. The approval of this first-line Phase III study further expands the applicable patient population for Opatisumimab in the EP-NEC field, fundamentally reshaping the treatment landscape for this cancer type.

The randomized, double-blind, multicenter Phase III clinical study will be led by Professor Shen Lin from Beijing Cancer Hospital and is being conducted simultaneously across multiple hospitals nationwide. The approval for this study is based on the breakthrough efficacy and favorable safety profile demonstrated by Opatisumimab in a Phase Ib/II proof-of-concept study. The proof-of-concept trial has been successfully completed, with detailed results planned for presentation at this year's ESMO congress.