SHANGHAI, China, March 29, 2024 (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 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(TM)), 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 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. 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 Information
IR Team:
Junshi Biosciences
info@junshipharma.com (mailto:info@junshipharma.com)
+ 86 021-6105 8800
PR Team:
Junshi Biosciences
Zhi Li
zhi_li@junshipharma.com (mailto:zhi_li@junshipharma.com)
+ 86 021-6105 8800
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