Guangzhou and London – May 22, 2025 – Bio-Thera Solutions,
Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a
pipeline of biosimilars and innovative assets and Hikma Pharmaceuticals PLC,
along with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc. today announced
that the U.S. Food and Drug Administration (FDA) has approved STARJEMZA® (ustekinumab-hmny) Injection, a biosimilar
referencing Stelara® (ustekinumab) Injection. STARJEMZA® is Bio-Thera’s third FDA approved product.
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 and manufacturing of the product.
Hikma is responsible for the commercialization of STARJEMZA® in the
United States.
“The approval of STARJEMZA® is another significant
accomplishment for Bio-Thera, establishing Bio-Thera as a premier global
biosimilar developer and manufacturer,” said Shengfeng Li, CEO at Bio-Thera.
“As our third FDA approved biosimilar, STARJEMZA® demonstrates
Bio-Thera’s commitment to developing more biosimilars, expanding patient access
to important therapies.”
“This approval and our partnership with Bio-Thera enables us to strongly
enter the U.S. biosimilar market, building on our well-established position as
a top-three domestic provider of sterile injectable medicines to U.S.
hospitals, healthcare providers, and patients,” said Dr. Bill Larkins,
President of Hikma Injectables. “Tapping into the robust ongoing growth of the
U.S. biosimilar market is a priority for Hikma. We are eager to use our
excellent U.S. commercial capabilities to launch this important product and
provide it to the many patients who will benefit from using it.”
The FDA approval of STARJEMZA®, originally known as BAT2206,
was based on a comprehensive analytical, non-clinical, and clinical data
package submitted by Bio-Thera to the FDA. Extensive analytical
characterization between STARJEMZA® and US and EU Stelara® was conducted on structural, physicochemical, and biological properties to
support bio-similarity of STARJEMZA®. A randomized double-blind, single-dose, three-arm, parallel phase
I study compared the pharmacokinetics,
safety, and immunogenicity of STARJEMZA® with both the US and EU
Stelara® in healthy volunteers. A multicenter, randomized,
double-blind, parallel-arm, phase III study compared
STARJEMZA® with Stelara® for efficacy, safety, and
immunogenicity in patients with moderate to severe plaque psoriasis. The
totality of the evidence demonstrated that STARJEMZA® has similar
efficacy, safety, immunogenicity, and quality as the reference product
ustekinumab.
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® in
the US, and BAT1806/TOFIDENCETM (tocilizumab) and AVZIVI® (bevacizumab-tnjn)
in the US, a/k/a POBEVCY® in EU and 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 ue09o.whjinling.com/en/ or
follow us on X (@bio_thera_sol)
and WeChat (Bio-Thera).
About Hikma Pharmaceuticals
(LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated BBB/stable S&P and
BBB-/positive Fitch) Hikma helps put better health within reach every day for
millions of people around the world. For more than 45 years, we've been
creating high-quality medicines and making them accessible to the people who
need them. Headquartered in the UK, we are a global company with a local
presence across North America, the Middle East and North Africa (MENA) and
Europe, and we use our unique insight and expertise to transform cutting-edge
science into innovative solutions that transform people's lives. We're
committed to our customers, and the people they care for, and by thinking
creatively and acting practically, we provide them with a broad range of
branded and non-branded generic medicines. Together, our 9,500 colleagues are
helping to shape a healthier world that enriches all our communities. We are a
leading licensing partner, and through our venture capital arm, are helping
bring innovative health technologies to people around the world. For more
information, please visit: www.hikma.com
Cautionary Note Regarding
Forward-Looking Statements
This news release contains certain forward-looking statements relating to
STARJEMZA®/BAT2206 or the product pipelines in general of
Bio-Thera Solutions and Hikma. 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 Hikma 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 and Hikma undertake
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.
1) STARJEMZA® is a registered trademark of
Hikma Pharmaceuticals USA Inc.
2) STELARA® is a registered trademark of
Johnson and Johnson
3) QLETLI® is a registered trademark of
Bio-Thera Solutions, Ltd.
4) BETAGRIN® is a registered
trademark of Bio-Thera Solutions, Ltd.
5) TOFIDENCE™ is a trademark of Organon LLC
6) AVZIVI® is a registered trademark of Sandoz
7) POBEVCY® is a registered trademark of
Bio-Thera Solutions, Ltd.
