GUANGZHOU,
China - Bio-Thera Solutions (688177.SH), a commercial-stage biopharmaceutical company
developing innovative therapies and biosimilars, announced that its partner, Hikma
Pharmaceuticals USA Inc. officially launched STARJEMZA™ (ustekinumab-hmny)
Injection, a biosimilar referencing STELARA® in the United States. The U.S.
Food and Drug Administration approved STARJEMZA™ in May 2025 for the treatment
of severe plaque psoriasis (PsO), active psoriatic arthritis (PsA), moderate to
severe active Crohn's disease (CD), and moderate to severe active ulcerative
colitis (UC) in the United States. At launch, STARJEMZA™ is currently marketed
in the United States in two different subcutaneous injection formulations
(45mg/0.5mL and 90mg/L) and one intravenous injection formulation (130mg/26mL).
“The
U.S. commercial launch of STARJEMZA™ is a significant milestone for Bio-Thera.
said Shengfeng Li, CEO at Bio-Thera. Bio-Thera is committed to addressing unmet
patient needs, as represented by this new therapeutic option that we are
delivering with our partner Hikma across the United States.”
Bio-Thera and
Hikma entered into a license and commercialization agreement for STARJEMZA™ in August
2021. Under the terms of the agreement, Bio-Thera is responsible for the
development, manufacturing and supply of the product. Hikma is responsible for
the commercialization of STARJEMZA™ in the United States.
About
STARJEMZA™ (ustekinumab-hmny) Injection
STARJEMZA™ is a
biosimilar to Janssen’s Stelara® which is a human monoclonal antibody that
inhibits the bioactivity of human IL-12 and IL-23 by preventing shared p40
subunit from binding to the IL-12Rβ1 receptor chain of IL-12 (IL-12Rβ1/β2) and
IL-23 (IL-12Rβ1/23R) receptor complexes on the surface of immune cells. IL-12
and IL-23 are involved in inflammatory and immune responses, such as natural
killer cell activation, CD4+ T-cell differentiation and following relative
cytokines stimulated release. Abnormal regulation of IL-12 and IL-23 have been
implicated as important contributors to chronic inflammation, including
psoriasis, psoriatic arthritis (PsA), Crohn’s disease (CD), and Ulcerative
colitis (UC). Neutralizing human IL-12 and IL-23 by STARJEMZA® to prevent the
relevant cell signaling in the Th1 or Th17 lineages can effectively block the
pathologic processes of these immune disorders.
About
Bio-Thera Solutions
Bio-Thera Solutions,
Ltd., a leading innovative, global biopharmaceutical company in Guangzhou,
China, is dedicated to researching and developing novel therapeutics for the
treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe
unmet medical needs, as well as biosimilars for existing, branded biologics to
treat a range of cancer and autoimmune diseases. As a leader in next generation
antibody discovery and engineering, the company has advanced multiple
candidates into late-stage development, including five approved products:
QLETLI® (adalimumab) and BETAGRIN® (bevifibatide citrate) Injection in China,
STARJEMZA™ (ustekinumab) in the US and Usymro®(ustekinumab) in EU, and
TOFIDENCE™/BAT1806 (tocilizumab) and AVZIVI® (bevacizumab-tnjn) in the US
and in EU, a/k/a POBEVCY® in China. In addition, the company has more than 20
promising candidates in clinical trials, focusing on immuno-oncology in the
post-PD-1 era and targeted therapies such as antibody-drug conjugates (ADCs).
For more information, please visit www.bio-thera.com/en/ or follow us
on X @bio_thera_sol) and WeChat
(Bio-Thera).
Cautionary
Note Regarding Forward-Looking Statements
This news release contains certain forward-looking statements
relating to STARJEMZA™ (BAT2206) and businesses of Bio-Thera Solutions. Readers
are strongly cautioned that reliance on any forward-looking statements involves
known and unknown risks and uncertainties. The forward-looking statements
include, among others, those containing "could," "may,"
"should," "will," "would," "anticipate,"
"believe," "plan," "promising,"
"potentially," or similar expressions. They reflect the company's
current views with respect to future events that are based on what the company
believes are reasonable assumptions in view of information currently available
to Bio-Thera Solutions, and are not a guarantee of future performance or
developments. Actual results and events may differ materially from information
contained in the forward-looking statements as a result of a number of factors,
including, but not limited to, risks and uncertainties inherent in
pharmaceutical research and development, such as the uncertainties of
pre-clinical and clinical studies, for example, the development processes could
be lengthy and high in vitro affinity may not translate to desired results in
vivo or successful clinical studies. Other risks and uncertainties include
challenges in obtaining regulatory approvals, manufacturing, marketing,
competition, intellectual property, product efficacy or safety, changes in
global healthcare situation, changes in the company's financial conditions, and
changes to applicable laws and regulations, etc. Forward-looking statements
contained herein are made only as of the date of their initial publication.
Unless required by laws or regulations, Bio-Thera Solutions undertakes no
obligation to publicly update any forward-looking statement, whether as a
result of new information, future events, changes in the company's views or
otherwise.
