LEADS BIOLABS-B(09887): The phase II study of Weixin for the treatment of hepatocellular carcinoma has successfully entered the expansion stage.

LEADS BIOLABS-B (09887) announced that the phase II clinical study of its self-developed PD-L1/4-1BB bispecific antibody Opalizumab (Vilexin) for first-line treatment of hepatocellular carcinoma (HCC) has successfully completed the safety introduction phase evaluation following expert review and has smoothly entered the expansion stage. This study is led by Professor Zhou Jian, the director of Zhongshan Hospital affiliated with Fudan University and an academician of the Chinese Academy of Sciences. Preliminary data from the study show that Opalizumab combined with bevacizumab exhibits clear and positive efficacy signals in HCC patients, with overall safety and tolerability being good. HCC is the fourth most common malignancy in China and the second leading cause of cancer-related deaths, with approximately 368,000 new cases and about 317,000 deaths each year. HCC has an insidious onset, and less than 30% of patients are suitable for radical treatment at the time of initial diagnosis. Systemic anti-tumor therapy plays a crucial role in the treatment of mid to late-stage HCC. Currently, PD-1/PD-L1 inhibitors combined with bevacizumab have become one of the standard first-line treatments for advanced HCC both domestically and internationally; however, the median overall survival for patients is only 19 to 20 months, with a median progression-free survival of less than 7 months and an objective response rate not exceeding 30%. More effective treatment options are urgently needed. Opalizumab has demonstrated strong efficacy signals and breakthrough therapeutic potential in several types of tumors, including extrapulmonary neuroendocrine carcinoma (EP-NEC), non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and biliary tract cancer (BTC). Based on the conditional activation design of the X-bodyTM platform, its good safety has been verified in nearly 800 patients. This further validation in HCC strengthens Opalizumab's status as a foundational therapy for IO2.0 across tumors.