SHANGHAI, March 13, 2026 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd ("Junshi Biosciences," HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced its financial results for the full year of 2025 and provided corporate updates.
FINANCIAL HIGHLIGHTS
-- Total revenue of Junshi Biosciences was approximately RMB2,498 million in
2025, representing an increase of approximately 28% compared to 2024,
which was mainly due to the increase in revenue from sales of
pharmaceutical products, in particular the domestic sales revenue of the
company's core product, toripalimab, was approximately RMB2,068 million,
representing an increase of approximately 38% compared to 2024.
-- Total research and development ("R&D") expenses of the company were
approximately RMB1,384 million in 2025, representing an increase of
approximately 9% compared to 2024. The increase in R&D expenses was
mainly due to the company's focus on more competitive and innovative R&D
pipelines and accelerated clinical development in 2025.
-- Net cash inflow from financing activities was approximately RMB2,232
million, which fully covered the cash outflows in operating and investing
activities, leading to an increase in bank balances and cash. A
successful placing of new H shares on 20 June 2025 generated a net cash
inflow of approximately RMB940 million for the company.
-- As of the end of 2025, the company's aggregate balance of bank balances
and cash and financial products was approximately RMB3,195 million,
providing a relatively sufficient cash position to support the company's
development.
BUSINESS HIGHLIGHTS
During 2025, our commitment to addressing "unmet medical needs" has driven original, innovative and breakthrough progress in the discovery, R&D and commercialization of innovative therapies and drugs through accelerating international development. Here are the notable achievements and milestones:
-- Advancements in the pipeline: Junshi Biosciences' innovative R&D field
has expanded from monoclonal antibodies to the research and development
of various drug modalities, including small molecule drugs, polypeptide
drugs, antibody drug conjugates $(ADC)$, bi-specific or multi-specific
antibodies, bispecific antibody drug conjugates, fusion protein, nucleic
acid drugs and vaccines, as well as the exploration of next-generation
innovative therapies, including those for cancer and autoimmune diseases.
A total of four drugs have been commercialized, a number of products are
undergoing phase 3 clinical studies or in the stage of marketing
application, and various innovative drugs that are competitive in the
international market are undergoing accelerated clinical trials.
-- In January 2025, the indication of toripalimab for the treatment
of unresectable or metastatic melanoma after failure of standard
systemic therapy was approved by the National Medical Products
Administration of China (the "NMPA") for conversion from
conditional approval to regular approval.
-- In January 2025, the investigational new drug ("IND") application
for JS212 [a recombinant humanized epidermal growth factor
receptor ("EGFR") and human epidermal growth factor receptor 3
("HER3") bispecific ADC] was accepted by the NMPA. It was approved
by the NMPA in March 2025. The IND application of JS212
multi-cohort combined drug application was approved by the NMPA in
November 2025. In December 2025, the IND application for JS212 for
the treatment of advanced solid tumors was approved by the U.S.
Food and Drug Administration ("FDA").
-- In January 2025, the indication of VV116/JT001 (MINDEWEI) for the
treatment of adult patients with mild to moderate coronavirus
disease 2019 ("COVID-19") was approved by the NMPA for conversion
from conditional approval to regular approval.
-- In January 2025, the New Chemical Entity ("NCE") application for
toripalimab in combination with cisplatin and gemcitabine, for the
first-line treatment of adults with metastatic or recurrent,
locally advanced nasopharyngeal carcinoma ("NPC") and toripalimab,
as a single agent, for the treatment of adults with recurrent
unresectable or metastatic NPC with disease progression on or
after a platinum-containing chemotherapy was approved by the
Therapeutic Goods Administration of the Australian Government
Department of Health and Aged Care (the "TGA"). Toripalimab became
the first immuno-onocology treatment for NPC in Australia.
-- In February 2025, the IND application for JS213 (a PD-1 and
interleukin-2 ("IL-2") bifunctional antibody fusion protein) was
approved by the NMPA.
-- In March 2025, the supplemental new drug application (the "sNDA")
for toripalimab in combination with bevacizumab for the first-line
treatment for patients with unresectable or metastatic
hepatocellular carcinoma ("HCC") was approved by the NMPA.
-- In March 2025, the new drug application (the "NDA") for
toripalimab in combination with cisplatin and gemcitabine for the
first-line treatment of adult patients with recurrent, not
amenable to surgery or radiotherapy, or metastatic NPC was
approved by the Singapore Health Sciences Authority (the "HSA").
Toripalimab became the first approved immuno-oncology treatment
for NPC in Singapore.
-- In April 2025, the sNDA for toripalimab for the first-line
treatment of unresectable or metastatic melanoma was approved by
the NMPA. This is the 12th indication of toripalimab approved in
Chinese Mainland.
-- In May 2025, the two sNDAs for the ongericimab injection (a
recombinant humanized anti-PCSK9 monoclonal antibody injection,
trade name: JUNSHIDA) for: 1) adult patients with heterozygous
familial hypercholesterolemia ("HeFH"); 2) alone or in combination
with ezetimibe, in adult patients with non-familial
hypercholesterolemia and mixed dyslipidemia who are
statin-intolerant or statins contraindicated, were approved by the
NMPA. Ongericimab became the first domestic PCSK9-targeted drug
approved for statin-intolerant patients.
-- In June 2025, the IND application for the JT118 injection
("JT118") was accepted. It was approved by the NMPA in September
2025. JT118 is a "two-in-one" recombinant protein vaccine composed
of a tandem fusion of monkeypox virus antigens A35 (an
extracellular enveloped virus antigen) and M1 (an intracellular
mature virus antigen), and is intended mainly for the prevention
of monkeypox virus infection.
-- In June 2025, the indications of toripalimab for the first-line
treatment of NPC and the first-line treatment of esophageal
squamous cell carcinoma ("ESCC") were officially approved for
marketing in the United Arab Emirates (the "UAE") and Kuwait.
-- In August 2025, the sNDA for toripalimab in combination with
disitamab vedotin as the treatment of HER2-expressing (HER2
expression is defined as HER2 immunohistochemistry results of 1+,
2+, or 3+) locally advanced or metastatic UC was accepted by the
NMPA.
-- In September 2025 and October 2025, the two indications for
toripalimab in combination with cisplatin and gemcitabine for the
first-line treatment of adults with metastatic or recurrent,
locally advanced NPC, and toripalimab, as a single agent, for the
treatment of adults with recurrent, unresectable or metastatic NPC
with disease progression on or after a platinum-containing
chemotherapy were approved for marketing in Pakistan and Canada,
respectively.
-- In October 2025, the IND application for an open-label, two-arm,
randomized, active-controlled, phase 2/3 clinical study comparing
JS207 (recombinant humanized anti-PD-1/VEGF bispecific antibody),
to nivolumab for the neoadjuvant treatment of patients with stage
2/3, resectable, actionable genomic aberration (AGA)-negative,
non-small cell lung cancer ("NSCLC") was approved by the FDA.
-- In November 2025, a new indication of toripalimab in combination
with chemotherapy as first-line treatment of ESCC was approved in
Hong Kong SAR, China.
-- In November 2025, the multi-center, open-label, randomized
controlled phase 3 clinical study comparing JS001sc (toripalimab
injection for subcutaneous use) to toripalimab in combination with
chemotherapy for the first-line treatment of recurrent or
metastatic non-squamous NSCLC met its primary endpoints.
-- In December 2025, the NDA for JS005 (roconkibart injection, a
recombinant humanized anti-IL-17A monoclonal antibody injection),
for the treatment of adult patients with moderate to severe plaque
psoriasis who are candidates for systemic therapy or phototherapy
was accepted.
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