Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited do not accept responsibility for the contents of the original announcement, make no representation as to its accuracy or completeness, and expressly disclaim any liability for any loss arising from or in reliance upon any part of its contents. According to details provided by Nanjing Leads Biolabs Co., Ltd. (a joint stock company established in the People’s Republic of China with limited liability), the voluntary announcement was released to update shareholders and potential investors on recent progress.
Nanjing Leads Biolabs Co., Ltd. announced that the first patient has been successfully dosed in a Phase II clinical study of Opamtistomig (LBL-024, a PD-L1/4-1BB bispecific antibody) for the first-line treatment of hepatocellular carcinoma. This marks notable progress in expanding the indications of this core product.
The open-label, multi-center Phase II trial is led by Professor Jian Zhou of Zhongshan Hospital, Fudan University, with multiple sites participating. The initiative focuses on evaluating the efficacy and safety of Opamtistomig in combination regimens for the first-line treatment of hepatocellular carcinoma.
LBL-024 is a bispecific antibody targeting PD-L1 and 4-1BB. It is the first treatment targeting the 4-1BB receptor to have advanced to the registrational stage globally for extra-pulmonary neuroendocrine carcinoma (EP-NEC), with the potential to become the first approved therapy for advanced EP-NEC. The design of LBL-024 leverages optimal 2:2 structural configuration, aiming to relieve PD-1/L1 immunosuppression and enhance 4-1BB–regulated T-cell activation. Earlier regulatory milestones include approval from the National Medical Products Administration (NMPA) for a single-arm registrational trial in April 2024, receipt of Breakthrough Therapy Designation in October 2024 for late-line advanced EP-NEC, and Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration in November 2024.
In accordance with Rule 18A.05 of the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited, the original announcement emphasizes that there is no guarantee of LBL-024’s successful development or commercialization. Shareholders and potential investors are advised to exercise due care when dealing in shares of the Company.
This information was released by order of the Board of Nanjing Leads Biolabs Co., Ltd. on November 10, 2025. The Board of Directors comprises Executive Directors Dr. Kang Xiaoqiang (Chairman), Dr. Lai Shoupeng, and Mr. Zuo Honggang; Non-Executive Directors Mr. Zhang Yincheng, Dr. Chen Renhai, and Dr. Ni Jia; and Independent Non-Executive Directors Dr. Zhang Hongbing, Mr. Du Yilong, and Ms. Du Jiliu.