Nanjing Leads Biolabs Co Ltd

Nanjing Leads Biolabs announced that its Phase II study of Opamtistomig, a PD-L1/4-1BB bispecific antibody, combined with bevacizumab for first-line hepatocellular carcinoma has advanced into the expansion phase after a positive safety run-in review. Preliminary data showed encouraging anti-tumor activity and a favorable safety profile in HCC patients. The trial is led by Professor Zhou Jian of Zhongshan Hospital, Fudan University. Opamtistomig has demonstrated promising efficacy across multiple tumor types and has been evaluated in nearly 800 patients, maintaining a safety profile comparable to PD-1/PD-L1 inhibitors. The company aims to accelerate global development of this potential next-generation immunotherapy.

Nanjing Leads Biolabs has received clearance from China's National Medical Products Administration to begin a Phase Ib/II clinical trial of its bispecific antibody Opamtistomig in combination therapy for metastatic colorectal cancer. The investigational new drug application was approved by the Centre for Drug Evaluation, marking an expansion of the drug's indications into gastrointestinal cancers. Opamtistomig, also known as LBL-024, is a proprietary PD-L1/4-1BB bispecific antibody developed on the company's X-Body platform and is already under evaluation for several other cancer types. Shares of Nanjing Leads, which closed Friday at HK$53.40, were up 4.31% at HK$55.70 following the announcement.