Junshi Biosciences Announces 2023 Full Year Financial Results and Provides Corporate Updates
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$(R)$ (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(R), 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(R) 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(R) 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(R) 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(R) 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(R) 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(R) 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(R)
indications were added, bringing the total to six indications
included in the NRDL. TUOYI(R) 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
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