Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited take no responsibility for the contents of the announcement referenced here, make no representation as to its accuracy or completeness, and expressly disclaim any liability whatsoever for any loss arising from or in reliance upon any part of its contents.
Nanjing Leads Biolabs Co., Ltd. (the “Company,” together with its subsidiaries, the “Group”) announced on a voluntary basis that the first patient has been successfully enrolled in a Phase II clinical study of Opamtistomig (LBL-024), a PD-L1/4-1BB bispecific antibody, for first-line esophageal squamous cell carcinoma (ESCC). The open-label, multi-center Phase II trial is led by Professor Shen Lin of Beijing Cancer Hospital and is being conducted across multiple hospitals in China, focusing on evaluating the efficacy and safety of Opamtistomig in first-line ESCC.
According to the announcement, LBL-024 is a bispecific antibody targeting PD-L1 and 4-1BB. The agent has progressed to a registrational stage for extrapulmonary neuroendocrine carcinoma (EP-NEC) and is in Phase II or registrational clinical trials for non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and EP-NEC. LBL-024 demonstrated potential for first-in-class or best-in-class clinical activity, along with favorable safety profiles in multiple tumor types such as NSCLC, SCLC, biliary tract cancer, ovarian cancer, ESCC, hepatocellular carcinoma, gastric cancer, triple-negative breast cancer, and melanoma. In China-based clinical trials, LBL-024 has shown encouraging efficacy signals in advanced EP-NEC both as monotherapy and in combination with chemotherapy. The Company received regulatory approvals and designations for LBL-024 in EP-NEC from the National Medical Products Administration (NMPA) in April 2024, Breakthrough Therapy Designation in October 2024, Orphan Drug Designation from the FDA in November 2024, Fast Track Designation from the FDA in January 2026, and Orphan Drug Designation from the EC in January 2026.
Esophageal cancer in China largely manifests as squamous cell carcinoma. Data published in 2022 by the International Agency for Research on Cancer indicates that ESCC ranked seventh among all cancers in the country, with an estimated 0.22 million new cases and approximately 0.19 million deaths annually. Late-stage diagnoses are common, making prognosis poor, with a five-year survival rate of 10.00% to 30.00%.
Pursuant to Rule 18A.05 of the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited, the Company cannot guarantee successful development or marketing of LBL-024. Shareholders and potential investors are advised to exercise caution when dealing in the Company’s shares.
By order of the Board of Nanjing Leads Biolabs Co., Ltd., the announcement was issued in Nanjing, PRC, on March 6, 2026. The board of directors of the Company comprises: (i) Dr. Kang Xiaoqiang (Chairman of the Board), Dr. Lai Shoupeng, and Mr. Zuo Honggang as executive Directors; (ii) Mr. Zhang Yincheng, Dr. Chen Renhai, and Dr. Ni Jia as non-executive Directors; and (iii) Dr. Zhang Hongbing, Mr. Du Yilong, and Ms. Du Jiliu as independent non-executive Directors.
Comments