Nanjing Leads Biolabs Co., Ltd. (Stock Code: 9887) announced that the first patient has been dosed in a Phase II clinical study evaluating Opamtistomig (LBL-024), a PD-L1/4-1BB bispecific antibody, as a first-line treatment for advanced biliary tract cancer. Led by Professor Jian Zhou of Zhongshan Hospital, Fudan University, the multi-center trial aims to assess the efficacy and safety of Opamtistomig in combination regimens.

LBL-024 is noted by the company as the first 4-1BB receptor–targeting treatment to have reached a registrational stage globally for extra-pulmonary neuroendocrine carcinoma (EP-NEC). Plans are in place to establish it as a potential first approved therapy for advanced EP-NEC. In April 2024, national regulators approved a single-arm registrational trial for LBL-024, and the candidate later received Breakthrough Therapy Designation from the National Medical Products Administration in October 2024 and Orphan Drug Designation from the U.S. Food and Drug Administration in November 2024. The company cautions that there is no guarantee of successful development or commercialization of LBL-024, urging investors and shareholders to exercise due care.