Junshi Biosciences Announces 2024 Full Year Financial Results and Provides Corporate Updates
SHANGHAI, March 28, 2025 (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 2024 and provided corporate updates.
FINANCIAL HIGHLIGHTS
-- Total revenue of Junshi Biosciences was approximately RMB1,948 million in
2024, representing an increase of approximately 30% compared to 2023,
which was mainly due to the increase in revenue from pharmaceutical
products, in particular: the domestic sales revenue of our core product,
toripalimab, was approximately RMB1,501 million, representing an increase
of approximately 66% compared to 2023.
-- Total research and development ("R&D") expenses of the company were
approximately RMB1,275 million in 2024, representing a decrease of
approximately 34% compared to 2023. The decrease in R&D expenses was
mainly due to the company's cost control policy and efforts to optimize
resource allocation and focus on R&D pipelines with greater potential. In
addition, a number of clinical trials of our core product, toripalimab,
successively met the primary endpoints, which also contributed to the
natural decline of R&D expenditure.
-- Loss attributable to owners of the company decreased to RMB1,282 million
in 2024, representing a decrease of approximately RMB999 million or
approximately 44% compared to 2023.
-- As of the end of 2024, the company's aggregate balance of bank balances
and cash and financial products was approximately RMB2,917 million,
ensuring a relatively sufficient cash position to support the company's
development.
BUSINESS HIGHLIGHTS
During 2024, 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 (ADCs), bi-specific or multi-specific
antibodies, bispecific antibody drug conjugates, fusion protein and
nucleic acid drugs, as well as the exploration of next-generation
innovative therapies, including cancer and autoimmune diseases. Our
product pipelines cover five major therapeutic areas, including malignant
tumors, autoimmune diseases, chronic metabolic diseases, neurologic
diseases and infectious diseases. A total of four drugs have been
commercialized, around 30 assets are undergoing clinical trials, and over
20 drug candidates are at the preclinical drug development stage.
-- In January 2024, Coherus BioSciences, a partner of Junshi
Biosciences, announced that toripalimab was available for access
and administration in the United States. Prior to this,
toripalimab (US trade name: LOQTORZI$(R)$) was approved for
marketing by the US Food and Drug Administration (the "FDA") in
October 2023, and is the first drug for the treatment of
nasopharyngeal carcinoma ("NPC") in the United States. At present,
it is also the only preferred drug recommended in the National
Comprehensive Cancer Network ("NCCN") Clinical Practice Guidelines
in Oncology for Head and Neck Cancers 2025.V1 for the treatment of
recurrent/ metastatic NPC across all lines.
-- In January 2024, the new drug application (the "NDA") for
toripalimab for the treatment of NPC was accepted by the Singapore
Health Sciences Authority (the "HSA"). In March 2025, the NDA for
toripalimab (Singapore trade name: LOQTORZI(R)) 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 has been approved by the HSA.
Toripalimab has become the first and only approved immuno-oncology
treatment for NPC in Singapore.
-- In April 2024, the Japanese Pharmaceuticals and Medical Devices
Agency (the "PMDA") agreed that the company may proceed with a
randomized, double-blind, placebo-controlled, international
multi-regional phase 3 clinical study of tifcemalimab (a
recombinant humanized anti-BTLA monoclonal antibody, code:
TAB004/JS004) in combination with toripalimab as consolidation
therapy for patients with limited-stage small cell lung cancer
("LS-SCLC") without disease progression following
chemo-radiotherapy.
-- In April 2024, the supplemental new drug application (the "sNDA")
for toripalimab in combination with axitinib for the first-line
treatment for patients with medium to high risk unresectable or
metastatic renal cell carcinoma ("RCC") was approved by the
National Medical Products Administration of China (the "NMPA").
This is the first approved immunotherapy for renal carcinoma in
China.
-- In April 2024, the NDA for toripalimab in combination with
cisplatin and gemcitabine for 1) the first-line treatment of
adults with metastatic or recurrent locally advanced NPC and 2)
toripalimab, as a single agent, for the treatment of adults with
recurrent, unresectable, or metastatic NPC with disease
progression on or after platinum-containing chemotherapy was
accepted by the Drug Office of the Department of Health, Hong Kong
Special Administration Region Government (the "DO"), and was
approved by the Pharmacy and Poisons Board of Hong Kong (the
"PPB") in October 2024, making toripalimab the first and only
immunotherapy drug for NPC in Hong Kong SAR, China.
-- In June 2024, the primary endpoints of progression-free survival
("PFS", based on independent radiographic review) and overall
survival ("OS") of a multinational multi-center, randomized,
open-label, active controlled phase III clinical study (the
HEPATORCH study, NCT04723004) of TUOYI(R) in combination with
bevacizumab for the first-line treatment of advanced
hepatocellular carcinoma ("HCC") met the pre-defined efficacy
boundary. The sNDA was accepted by the NMPA in July 2024 and was
approved by the NMPA in March 2025.
-- In June 2024, the sNDA for TUOYI(R) in combination with
etoposidein plus platinum as the first-line treatment of
extensive-stage small cell lung cancer ("ES-SCLC") was approved by
the NMPA.
-- In June 2024, the sNDA for TUOYI(R) in combination with paclitaxel
for injection (albumin-bound) for the first-line treatment of
recurrent or metastatic triple-negative breast cancer ("TNBC")
with a well-validated test to evaluate PD-L1 positive (CPS >= 1)
was approved by the NMPA.
-- In July 2024, the investigational new drug ("IND") application for
JS125 (a targeted histone deacetylases ("HDACs") inhibitor) was
accepted by the NMPA and approved in September 2024.
-- In July 2024, a positive opinion was obtained from the Committee
for Medicinal Products for Human Use (the "CHMP") of the European
Medicines Agency (the "EMA") for the marketing authorization
application (the "MAA") of toripalimab (European trade name:
LOQTORZI(R)), which recommended approval for the treatment of two
indications: 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, and toripalimab in combination with cisplatin and paclitaxel
for the first-line treatment of adult patients with unresectable
advanced, recurrent, or metastatic esophageal squamous cell
carcinoma ("ESCC"). In September 2024, this MAA was approved by
the European Commission (the "EC"). The approval is applicable to
all 27 member states of the European Union (the "EU"), Iceland,
Norway and Liechtenstein, making toripalimab the first and only
drug for the treatment of NPC and the only first-line treatment
for advanced or metastatic ESCC regardless of PD-L1 status in
Europe.
-- In August 2024, the sNDA for toripalimab as the first-line
treatment for unresectable or metastatic melanoma was accepted by
the NMPA.
-- In September 2024 and November 2024, toripalimab was approved for
marketing in India and Jordan, respectively, for the treatment of
two indications: 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. Toripalimab officially
commenced commercial sales in India in 2024.
-- In October 2024, the NDA for ongericimab injection (a recombinant
humanized anti-PCSK9 monoclonal antibody injection, trade name:
JUNSHIDA) as the treatment for adult patients with primary
hypercholesterolemia (non-familial) and mixed dyslipidemia was
approved for marketing by the NMPA.
-- In November 2024, toripalimab (UK trade name: LOQTORZI(R))
obtained the marketing authorisation from the United Kingdom's
(the "UK") Medicines and Healthcare products Regulatory Agency
(the "MHRA") for the treatment of two indications: 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, and toripalimab in
combination with cisplatin and paclitaxel for the first-line
treatment of adult patients with unresectable advanced, recurrent,
or metastatic ESCC. Toripalimab has become the first and only drug
for the treatment of NPC and the only first-line treatment for
advanced or metastatic ESCC regardless of PD-L1 status in the UK.
-- In November 2024, four new indications of toripalimab were
successfully included in Category B of the National Drug List for
Basic Medical Insurance, Work-Related Injury Insurance and
Maternity Insurance (Year 2024) (the "NRDL"). The ten approved
indications of toripalimab in the Chinese mainland were all
included in the NRDL, and TUOYI(R) is the only anti-PD-1
monoclonal antibody included in the NRDL for the treatment of
melanoma, perioperative treatment of non-small cell lung cancer
("NSCLC"), treatment of renal carcinoma and treatment of TNBC.
-- Update on business operations
-- In June 2024, Junshi Biosciences convened the 2023 annual general
meeting, the 2024 first class meeting of A shareholders and the
2024 first class meeting of H shareholders, and completed the
election of the fourth session of the Board of Directors and the
board of supervisors of the company and other matters.
-- In July 2024, Suzhou Union Biopharm Co., Ltd., a wholly-owned
subsidiary of Junshi Biosciences, received the CERTIFICATE OF GMP
COMPLIANCE OF A MANUFACTURER issued by The Ireland Health Products
Regulatory Authority (the "HPRA") in accordance with the relevant
regulations of the EMA. This is the first time that the relevant
production facilities of toripalimab obtained the GMP certificate
of a member state of the EU. According to the GMP mutual
recognition system among the EU member states, obtaining the GMP
certificate indicates that the production facilities with the
certificate have met the GMP standards of the EU.
-- In August 2024, the A shares of Junshi Biosciences ("A Shares")
were included in the SSE STAR Brand Name Drug Index. The index
selects 30 securities of companies listed on the STAR Market with
the largest market capitalization and engaged in innovative drugs
as constituents, reflecting the overall performance of the
securities of the companies listed on the STAR Market and engaged
in innovative drugs.
-- As of September 2024, the company completed the implementation of
the A-Share repurchase plan, with a total of 815,871 A Shares
repurchased, accounting for 0.0828% of the total share capital of
the company, which will be used for the purpose of share
incentives and/or employee stock ownership plan(s) at an
appropriate time in the future.
-- In December 2024, the company's A Shares were included in the CSI
A500 Index. The index selects 500 securities with the largest
market capitalization and strong liquidity from various sectors as
constituents, reflecting the overall performance of the most
representative listed companies across different sectors.
About Junshi Biosciences
Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Five of the company's products have received approvals in China and international markets, one of which is toripalimab, China's first domestically produced and independently developed anti-PD-1 monoclonal antibody. Toripalimab has been approved in over 35 countries and regions including China, the US, and Europe. During the COVID-19 pandemic, Junshi Biosciences actively shouldered the social responsibilities of a Chinese pharmaceutical company through its involvement in developing etesevimab, MINDEWEI(R) , and other novel therapies for the prevention and treatment of COVID-19.
With a mission of "providing patients with world-class, trustworthy, affordable, and innovative drugs," Junshi Biosciences is "In China, For Global." At present, the company boasts approximately 2,500 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc.). For more information, please visit: http://www.junshipharma.com.
Junshi Biosciences Contact Information
IR Team:
Junshi Biosciences
info@junshipharma.com
+ 86 021-6105 8800
PR Team:
Junshi Biosciences
Zhi Li
zhi_li@junshipharma.com
+ 86 021-6105 8800
(END) Dow Jones Newswires
March 28, 2025 21:35 ET (01:35 GMT)