维立志博LBL-024胆道癌一线II期研究完成70例入组，疗效数据待10月ESMO披露

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announcement.
Nanjing Leads Biolabs Co., Ltd.
ԯၪʮ̡
(A joint stock company established in the People’s Republic of China with limited liability)
(Stock Code: 9887 )
VOLUNTARY ANNOUNCEMENT
COMPLETION OF FULL PATIENT ENROLLMENT IN PHASE II STUDY
OF LBL-024 (OPAMTISTOMIG, PD-L1/4-1BB BISPECIFIC ANTIBODY)
FOR BILIARY TRACT CANCER
This announcement is made by Nanjing Leads Biolabs Co., Ltd. (the “Company”, together
with its subsidiaries, the “Group”) on a voluntary basis to inform shareholders and potential
investors of the Company about the latest business development of the Company.
The Company is pleased to announce that the Phase II clinical study evaluating Opamtistomig
(LBL-024, a PD-L1/4-1BB bispecific antibody) for the treatment of first-line advanced
biliary tract cancer (BTC) has completed enrollment of all 70 patients. In April 2026, the
study successfully entered the expansion phase based on the favorable safety profile and
efficacy data that exceeded expectations. All patient enrollment was completed rapidly, fully
demonstrating the efficient clinical advancement and continuously validated significant
efficacy of LBL-024.
Although PD-(L)1 immunotherapy in combination with chemotherapy has become one of the
first-line standard treatments for advanced BTC in recent years, clinical benefit remains very
limited. Existing standard-of-care regimens represented by pembrolizumab plus chemotherapy
and durvalumab plus chemotherapy have an objective response rate (ORR) of less than 30%
and a median overall survival (OS) of only approximately 12–13 months, indicating that
clinical needs are far from being met. The potential of Opamtistomig as an IO 2.0 pan-tumor
cornerstone therapy has been continuously validated across three dimensions: broad-spectrum
anti-tumor activity, long-term survival benefit trends, and a safety profile comparable
to PD-(L)1 monoclonal antibodies. Existing data show that, following extrapulmonary
neuroendocrine carcinoma (EP-NEC) and small cell lung cancer (SCLC), Opamtistomig has
once again demonstrated highly competitive efficacy in BTC, a typical immune-cold tumor,
with the potential to elevate the efficacy of immunotherapy in BTC to new heights. Given that
the predominant pathological type of BTC is adenocarcinoma, combined with the positive
data previously observed in squamous cell carcinoma subtypes of major cancer types such
as non-small cell lung cancer (NSCLC), Opamtistomig has shown clear efficacy in both
adenocarcinoma and squamous cell carcinoma types, with its broad-spectrum anti-cancer
potential being continuously validated.

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The study is led by Academician Zhou Jian (մᄉ) of Zhongshan Hospital, Fudan University
(᙮ʕʆᔼ৫) and is being conducted across multiple hospitals in China. Safety
run-in data showed that LBL-024 in combination with chemotherapy demonstrated a favorable
overall safety profile and good tolerability, with no new safety signals identified. Preliminary
efficacy assessments showed an encouraging tumor shrinkage trend. Specific data will be
presented at the European Society for Medical Oncology (ESMO) Annual Meeting to be held
in Madrid, Spain from October 23 to 27, 2026.
ABOUT BTC
BTC mainly includes gallbladder cancer and intrahepatic and extrahepatic cholangiocarcinoma,
with approximately 419,100 new cases recorded globally in 2024. The vast majority of
BTC cases are adenocarcinomas, which are highly aggressive. Most patients are diagnosed
at an advanced stage, resulting in a poor prognosis, with a five-year survival rate of less
than 5%. Currently, the global incidence of BTC is on an upward trend, with the highest
prevalence observed in Asian countries. Although PD-1/PD-L1 inhibitors in combination
with chemotherapy have been approved as first-line treatment for advanced BTC, the overall
survival benefit remains limited, with median overall survival improving from approximately
11.5 months to 12.8 months, and the objective response rate (ORR) remaining below 30%,
indicating a significant unmet medical need.
ABOUT LBL-024 (OPAMTISTOMIG)
LBL-024 is a bispecific antibody simultaneously targeting PD-L1 and 4-1BB, and is a
pan tumor IO 2.0 cornerstone therapy with potential survival benefit. Leveraging our self
developed X-body™ platform with full intellectual property rights, LBL-024 achieves
conditional activation of 4-1BB, relieving PD-1/PD-L1 immunosuppression while enhancing
4-1BB regulated T-cell activation, achieving a synergistic effect in eliminating tumors. LBL024
demonstrates a safety profile comparable to PD-1/PD-L1 inhibitors and greater potential for
broad-spectrum cancer treatment, and has demonstrated first-in-class (FIC) or best-in class
(BIC) potential in non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC),
extrapulmonary neuroendocrine carcinoma (EP-NEC) and biliary tract cancer (BTC).
As the first molecule targeting the co-stimulatory receptor 4-1BB to have reached the pivotal
single-arm registrational clinical stage globally, LBL-024 has the potential to become the first
drug approved for treating EP-NEC. LBL-024 has initiated clinical studies across 13 solid
tumor indications in China, including one pivotal registrational clinical study and eight proof
of-concept studies, covering EP-NEC, NSCLC, SCLC, BTC, ovarian cancer (OC), esophageal
squamous cell carcinoma (ESCC), hepatocellular carcinoma (HCC), gastric cancer (GC),
triple-negative breast cancer (TNBC) and melanoma, among other areas with high unmet
medical needs.

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4-1BB, as an agonist, can reactivate apoptotic T cells and induce substantial proliferation,
making it suitable for treating “cold tumors” that are resistant or unresponsive to PD-1/PD-L1
therapies. LBL-024 received the Breakthrough Therapy Designation (BTD) from CDE of the
NMPA in October 2024, as well as the Orphan Drug Designation in treating neuroendocrine
carcinoma (NEC) from the FDA in November 2024. In January 2026, LBL-024 received
Fast Track Designation (FTD) from the FDA for the treatment of EP-NEC and Orphan Drug
Designation from the European Union.
Cautionary Statement required by Rule 18A.05 of the Rules Governing the Listing of
Securities on The Stock Exchange of Hong Kong Limited: The Company cannot guarantee
that it will be able to develop, or ultimately market, LBL-024 successfully. Shareholders and
potential investors of the Company are advised to exercise due care when dealing in the shares
of the Company.
By order of the Board
Nanjing Leads Biolabs Co., Ltd.
ԯ維ʮ̡
Dr. KANG XIAOQIANG
Chairman, Executive Director and
Chief Executive Officer
Nanjing, PRC, July 30, 2026
As at the date of this announcement, 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. Wu Fenglan as
non-executive Directors; and (iii) Dr. Zhang Hongbing, Mr. Du Yilong and Ms. Du Jiliu as
independent non-executive Directors.