维立志博LBL-024（PD-L1/4-1BB双抗）mCRC适应症Ib/II期完成首例患者入组，属早期管线拓展软催化

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Nanjing Leads Biolabs Co., Ltd.
南京 維立志博生物科技股份有限公司
(A joint stock company established in the People’s Republic of China with limited liability)

(Stock Code: 9887)

VOLUNTARY ANNOUNCEMENT
FIRST PATIENT ENROLLED IN PHASE IB/II CLINICAL TRIAL
OF LBL-024 (OPAMTISTOMIG, PD-L1/4-1BB BISPECIFIC
ANTIBODY) IN COMBINATION THERAPY FOR METASTATIC
COLORECTAL 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 first patient has been enrolled in the open-label,
multi-centre Phase Ib/II clinical trial evaluating its self-developed LBL-024 (Opamtistomig,
an anti-PD-L1/4-1BB bispecific antibody), in combination therapy for the treatment of
metastatic colorectal cancer ( “ mCRC ” ). This marks a further extension of the Company ’s
strategy of targeting immunologically “cold tumors” with LBL-024, following extrapulmonary
neuroendocrine carcinoma ( “ EP-NEC ” ), biliary tract cancer ( “ BTC ” ), hepatocellular
carcinoma (“HCC”) and platinum-resistant ovarian cancer (“PROC”).
In mCRC, patients with microsatellite stable ( “ MSS ” ) and proficient mismatch repair
( “ pMMR ” ) status account for approximately 95% of cases. Due to insufficient T-cell
infiltration in the tumor microenvironment, this patient population responds poorly to
conventional immune checkpoint inhibitors, and standard treatment remains centred on
chemotherapy combined with targeted therapy, leaving a significant need for new treatment
strategies. LBL-024 conditionally activates 4-1BB, which can reactivate and substantially
expand T cells while relieving PD-1/PD-L1 immunosuppression, and is expected to help
address the immunotherapy gap for this patient population and deliver long-lasting survival
benefits.

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The Phase Ib/II clinical trial is led by Academician Xu Ruihua of Sun Yat-sen University
Cancer Center and will be conducted concurrently across multiple hospitals nationwide, with
the aim of evaluating the efficacy and safety of LBL-024 in combination therapy in patients
with mCRC. A translational medicine study of LBL-024 in MSS colorectal cancer has been
selected for poster presentation at the 2026 European Society for Medical Oncology (“ESMO”)
Congress. LBL-024 has also demonstrated a trend of significantly prolonged survival benefits
compared with historical data across several representative immunologically “cold tumor ”
indications, including EP-NEC, BTC, HCC and PROC, providing mechanistic and clinical
support for the prospects of developing LBL-024 for the mCRC indication.

ABOUT COLORECTAL CANCER
CRC is one of the most common gastrointestinal malignancies worldwide. According to
the International Agency for Research on Cancer ( “ IARC ”), there were approximately 1.93
million new CRC cases and 904 thousand deaths globally in 2022, making CRC the third most
commonly diagnosed cancer and the second leading cause of cancer-related death worldwide.
According to the National Cancer Center of China, there were approximately 517 thousand
new CRC cases and 240 thousand deaths in China in 2022, ranking second and fourth among
all malignancies in terms of incidence and mortality, respectively. Approximately 15% to
30% of patients with CRC present with metastatic disease at initial diagnosis, while 20% to
50% of patients with initially localized CRC eventually develop mCRC. Despite advances in
treatment, mCRC remains associated with poor prognosis, with a five-year survival rate of
only approximately 15%. Currently, immunotherapies are primarily approved for patients with
microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) CRC. However,
these patients account for only approximately 5% of mCRC cases, whereas approximately 95%
of patients have microsatellite-stable (MSS) or mismatch repair-proficient (pMMR) disease,
which generally exhibits limited responsiveness to conventional immunotherapy, highlighting
a significant unmet medical need.

ABOUT LBL-024 (OPAMTISTOMIG)
LBL-024 is a bispecific antibody simultaneously targeting PD-L1 and 4-1BB, with the potential
to become a pan-tumor IO 2.0 cornerstone therapy that offers survival benefits. To date, LBL024 has been evaluated in clinical studies for 14 indications, including one pivotal singlearm registrational clinical study, one confirmatory Phase III clinical study and nine proof-ofconcept studies, covering multiple major cancer types and “cold tumors.” Among the seven
tumor types in which LBL-024 has been clinically validated, LBL-024 has demonstrated
outstanding clinical value and broad therapeutic prospects, including extrapulmonary
neuroendocrine carcinoma (EP-NEC), non-small cell lung cancer (NSCLC), small cell lung
cancer (SCLC), biliary tract cancer (BTC), hepatocellular carcinoma (HCC), esophageal
squamous cell carcinoma (ESCC) and ovarian cancer (OC).

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Leveraging our self-developed X-body™ platform with full intellectual property rights, LBL024 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. LBL-024 demonstrates a safety profile comparable to PD-1/PD-L1 inhibitors and
greater potential for broad-spectrum cancer treatment. In particular, activation of 4-1BB can
reactivate exhausted T cells and substantially promote their proliferation, making 4-1BBtargeted therapies potentially suitable for the treatment of immunologically “cold tumors” that
are resistant or unresponsive to PD-1/PD-L1 inhibitors, and may bring long-lasting survival
benefits.
In October 2024, LBL-024 was granted Breakthrough Therapy Designation by the NMPA,
and in November 2024, it received Orphan Drug Designation from the U.S. Food and Drug
Administration (the “FDA”). In January 2026, LBL-024 was granted Fast Track Designation
by the FDA and Orphan Drug Designation in the European Union. In September 2026,
LBL-024 was granted Orphan Drug Designation by Japan ’s Ministry of Health, Labour and
Welfare (“MHLW”). In July 2026, the Marketing Authorization Application of LBL-024 as
an innovative biological product was included in the NMPA ’s priority review and approval
procedure and was formally accepted in August 2026. LBL-024 is expected to become the
world’s first approved 4-1BB antibody drug, the world ’s first approved agonistic antibody drug
and the world’s first approved therapy targeting EP-NEC.
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.
南京維立志博生物科技股份有限公司
Dr. KANG XIAOQIANG
Chairman, Executive Director and
Chief Executive Officer
Nanjing, PRC, October 16, 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.

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