Junshi Biosciences Announces 2023 Full Year Financial Results and Provides Corporate Updates
March 29 2024 - 12:24AM
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 2023 and provided corporate updates.
FINANCIAL HIGHLIGHTS
- Total revenue was approximately RMB1,503 million during 2023.
The revenue from pharmaceutical products increased by approximately
58% compared to 2022. The sales revenue of TUOYI® (toripalimab) was
approximately RMB919 million, representing an increase of
approximately 25% compared to the previous year.
- Total research and development (“R&D”) expenses were
approximately RMB1,937 million in 2023, representing a decrease of
approximately 19% compared to 2022. The decrease in R&D
expenses was mainly due to the strategic management of R&D
investments in certain early-stage pipelines, while optimizing
resource allocation and focusing on R&D pipelines with greater
potential.
- Loss attributable to owners was RMB2,282 million in 2023,
representing a decrease of RMB104 million compared to the previous
year.
BUSINESS HIGHLIGHTS
During 2023, we continued to focus on “unmet medical needs” and
have made original, innovative and breakthrough progress in
discovery, R&D and commercialization of innovative therapies
and novel drugs. 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 more drug modalities,
including small molecules drugs, polypeptide drugs, antibody-drug
conjugates (ADCs), bi-specific or multi-specific antibodies and
nucleic acid drugs, as well as the exploration of next-generation
innovative therapies including cancer and autoimmune diseases. The
product pipelines cover five major therapeutic areas, including
malignant tumors, autoimmune diseases, chronic metabolic diseases,
neurologic diseases and infectious diseases. A total of three drugs
(TUOYI®, JUNMAIKANG and MINDEWEI) are being commercialized, around
30 assets are undergoing clinical trials, and over 20 drug
candidates are at the preclinical drug development stage.
- In January 2023, the marketing of MINDEWEI (Deuremidevir
Hydrobromide Tablets, code: JT001/VV116), an oral nucleoside analog
anti-SARS-CoV-2 Category 1 innovative drug, was conditionally
approved by the National Medical Products Administration of China
(the “NMPA”) for the treatment of adult patients with mild to
moderate COVID-19.
- In February 2023, the United Kingdom’s Medicines and Healthcare
products Regulatory Agency (the “MHRA”) accepted the the marketing
authorization application (the “MAA”) for toripalimab combined with
cisplatin and gemcitabine for the first-line treatment of patients
with locally recurrent or metastatic nasopharyngeal carcinoma
(“NPC”), as well as toripalimab combined with paclitaxel and
cisplatin for the first-line treatment of patients with
unresectable locally advanced/recurrent or metastatic esophageal
squamous cell carcinoma (“ESCC”).
- In March 2023, the investigational new drug (“IND”) application
for JS010 (a recombinant humanized anti-CGRP monoclonal antibody
injection) was approved by the NMPA.
- In April 2023, the NMPA accepted the supplemental new drug
application (“sNDA”) for TUOYI® in combination with chemotherapy as
perioperative treatment and monotherapy as consolidation therapy
after adjuvant therapy for the treatment of resectable stage III
non-small cell lung cancer (“NSCLC”). This application was later
approved for marketing in December 2023, marking the first and only
approved perioperative therapy for lung cancer domestically.
- In April 2023, the new drug application (“NDA”) for ongericimab
(a recombinant humanized anti-PCSK9 monoclonal antibody, code:
JS002) was accepted by the NMPA.
- In April 2023, the IND application for JS401 (a small
interfering RNA (“siRNA”) drug targeting angiopoietin-like protein
3 (“ANGPTL3”) messenger RNA (“mRNA”)) was approved by the
NMPA.
- In May 2023, the NMPA accepted the sNDA for TUOYI® in
combination with paclitaxel injection (albumin-bound) for the
treatment of PD-L1 positive (CPS ≥ 1) untreated metastatic or
recurrent metastatic triple-negative breast cancer.
- In June and August 2023, the IND application for a randomized,
double-blind, placebo-controlled, international multi-center phase
III clinical study of tifcemalimab (a recombinant humanized
anti-BTLA monoclonal antibody, code: TAB004/JS004) in combination
with toripalimab as consolidation therapy in patients with
limited-stage small cell lung cancer (“LS-SCLC”) without disease
progression following chemo-radiotherapy was approved by the U.S.
Food and Drug Administration (the “FDA”) and the NMPA,
respectively.
- In July 2023, the sNDA for TUOYI® in combination with axitinib
for the first-line treatment of patients with unresectable or
metastatic renal cell carcinoma (“RCC”) was accepted by the
NMPA.
- In July 2023, the sNDA for TUOYI® in combination with etoposide
plus platinum as the first-line treatment of extensive-stage small
cell lung cancer (“ES-SCLC”) was accepted by the NMPA, which marked
the tenth marketing application submitted for TUOYI® in China.
- In August 2023, the IND application for JS207 (a recombinant
humanized anti-PD-1/VEGF bispecific antibody) was approved by the
NMPA.
- In September 2023, the primary endpoint of progression free
survival (“PFS”, based on independent radiological review) of a
randomized, controlled, multi-center phase III clinical study
(NCT03430297) of toripalimab versus dacarbazine for the first-line
treatment of unresectable or metastatic melanoma had met the
pre-defined efficacy boundary.
- In October 2023, the FDA approved the Biologics License
Application (the “BLA”) for toripalimab (U.S. trade name:
LOQTORZI™), in combination with cisplatin and gemcitabine for the
first-line treatment of adults with metastatic or recurrent locally
advanced NPC, and as a single agent, for the treatment of adults
with recurrent, unresectable, or metastatic NPC with disease
progression on or after platinum-containing chemotherapy.
Toripalimab is the first and only drug approved in the United
States for the treatment of NPC, and is also the first innovative
biological drug independently developed and manufactured in China
that was approved for marketing by the FDA.
- In December 2023, the Therapeutic Goods Administration (the
“TGA”) of the Australian Government’s Department of Health and Aged
Care accepted the New Chemical Entity (the “NCE”) application for
toripalimab in combination with cisplatin and gemcitabine for the
first-line treatment of adults with metastatic or recurrent locally
advanced NPC, and as a single agent, for the treatment of adults
with recurrent, unresectable, or metastatic NPC with disease
progression on or after platinum-containing chemotherapy.
Additionally, the TGA also granted an orphan drug designation to
toripalimab for the treatment of NPC.
- In December 2023, TUOYI® and MINDEWEI were successfully added
to Category B of the National Drug List for Basic Medical
Insurance, Work-Related Injury Insurance and Maternity Insurance
(Year 2023) (the “NRDL”) upon negotiations. Notably, three new
TUOYI® indications were added, bringing the total to six
indications included in the NRDL. TUOYI® is the only anti-PD-1
monoclonal antibody included in the NRDL for the treatment of
melanoma. The inclusion of the MINDEWEI indication for adult
patients with mild to moderate COVID-19 marked its first official
listing in the NRDL.
- Update on external collaborations
- In March 2023, the company entered into a shareholders
agreement with Rxilient Biotech and its wholly-owned subsidiary,
Excellmab. The company would subscribe to the newly issued shares
of Excellmab by payment in kind to obtain 40% equity interest in
Excellmab. Subject to the fulfillment of the conditions precedent
as agreed under the Shareholders Agreement, the company would
substantially perform its capital contribution obligations, and
express its intention to enter into a license agreement with
Excellmab in the form agreed upon by the parties at the time of
entering into the Shareholders Agreement, thereby granting
Excellmab an exclusive license and other relevant rights to develop
and commercialize intravenous toripalimab in Thailand, Brunei,
Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines and
Vietnam. According to the R&D progress of toripalimab and other
matters, Junshi Biosciences may receive a milestone payment of up
to approximately US$4.52 million, plus a percentage of royalties on
the net sales.
- In May 2023, Junshi Biosciences entered into an exclusive
license and commercialization agreement with Dr. Reddy’s, pursuant
to which the company agreed to grant Dr. Reddy’s a license to
develop and exclusively commercialize toripalimab injection in
Brazil, Mexico, Colombia, Argentina, Peru, Chile, Panama, Uruguay,
India and South Africa. Dr. Reddy elected to expand the scope of
the license to cover Australia, New Zealand and nine other
countries.
About Junshi BiosciencesFounded 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. Four of the company’s innovations have
already reached the Chinese or international markets, one of which
is toripalimab, China’s first domestically produced and
independently developed anti-PD-1 monoclonal antibody, approved in
both China and the US. Additionally, more than 30 drugs are
currently in clinical development. During the COVID-19 pandemic,
Junshi Biosciences actively shouldered the social responsibilities
of a Chinese pharmaceutical company through its involvement in
developing etesevimab, MINDEWEI®, 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 3,000 employees in the United States (San Francisco
and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou,
etc). For more information, please visit:
http://junshipharma.com.
Junshi Biosciences Contact InformationIR
Team:Junshi Biosciencesinfo@junshipharma.com+ 86 021-6105 8800
PR Team:Junshi BiosciencesZhi Lizhi_li@junshipharma.com+ 86
021-6105 8800