维立志博-B(9887.HK)：LBL-024(奥帕替苏米单抗)一线治疗晚期胆道癌获FDA快速通道资格，为该药第二项FTD

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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
LBL-024 (OPAMTISTOMIG, PD-L1/4-1BB
BISPECIFIC ANTIBODY)
GRANTED FAST TRACK DESIGNATION BY THE U.S. FDA
FOR FIRST-LINE TREATMENT OF ADVANCED
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 its core product LBL-024 (Opamtistomig, an antiPD-L1/4-1BB bispecific antibody) has been granted Fast Track Designation by the U.S.
Food and Drug Administration (the “ FDA ”) for the first-line treatment of advanced biliary
tract cancer (“ BTC”)，which marks the second Fast Track Designation granted by the FDA
to LBL-024 following the designation for extrapulmonary neuroendocrine carcinoma (“ EPNEC ”). Based on the encouraging data demonstrated in the first-line BTC clinical study of
LBL-024, the Fast Track Designation was granted only nine days after submission. The FDA
has also recommended that the Company engage with it as soon as practicable regarding the
registrational plan for LBL-024 in combination with chemotherapy in BTC. The designation
is expected to accelerate the development, registration and commercialization of LBL-024 for
BTC in the United States.

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Fast Track Designation is intended to facilitate the development and expedite the review of
drugs and biological products for the treatment of serious or life-threatening conditions that
have the potential to address unmet medical needs. Following the designation, LBL-024 will
be eligible for a range of benefits, including but not limited to the following: (i) the Company
may engage in more frequent interactions with the FDA and receive tailored guidance on key
matters, including clinical trial design and data requirements, thereby helping to optimize
the development pathway; and (ii) subject to the relevant eligibility criteria being met, the
marketing application may be reviewed on a rolling basis, allowing completed sections to
be submitted for review before the entire application is finalized and thereby potentially
shortening the overall review timeline.
LBL-024 conditionally activates 4-1BB to expand T cells. Its differentiated advantage lies in its
potential to overcome the limited benefits of immunotherapy in immunologically “cold tumors”
and deliver long-lasting survival benefits. The Company initiated its first late-line Phase I/
IIa monotherapy basket trial of LBL-024 in 2022, enrolling 175 patients. The trial evaluated
LBL-024 across several cold-tumor indications, including BTC, platinum-resistant ovarian
cancer, late-line HCC resistant to prior PD-1 therapy, and late-line EP-NEC, and LBL-024
demonstrated a trend toward prolonged survival compared with historical data. The relevant
data are expected to be published in a leading international journal.
On this basis, LBL-024 has progressed rapidly from early exploration in later-line settings
to frontline clinical development and has continued to make progress in obtaining regulatory
designations. The clinical study of LBL-024 as a first-line treatment for BTC is currently
advancing efficiently. In April 2026, based on its favorable safety profile and efficacy data,
the Company advanced the Phase II clinical study of LBL-024 as a first-line treatment for
advanced BTC to the expansion stage and subsequently completed enrollment of all patients,
demonstrating the drug candidate’s breakthrough potential in immunologically “cold tumors.”
The Fast Track Designation provides further clarity on the potential registrational pathway for
the program in the United States.

ABOUT BILIARY TRACT MALIGNANCIES
Biliary tract malignancies primarily comprise gallbladder cancer and intrahepatic and
extrahepatic cholangiocarcinoma. There were approximately 419,100 new cases worldwide in
2024. The vast majority of biliary tract malignancies are adenocarcinomas. They are highly
aggressive, are often diagnosed at an advanced stage and have an extremely poor prognosis,
with a five-year survival rate of less than 5%. The global incidence of biliary tract malignancies
is increasing, with the diseases being particularly common in Asian countries. Although PD-1/
PD-L1 inhibitors in combination with chemotherapy have been approved as first-line treatment
for advanced biliary tract malignancies, the overall survival benefit remains limited, with
median overall survival increasing only from approximately 11.5 months to 12.8 months, while
the objective response rate ( “ ORR ”) remains below 30%. Substantial unmet clinical needs
therefore remain.
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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).
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.

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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 12, 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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