Guangzhou, China; November 10, 2025: Bio-Thera
Solutions (688177:SH; “Bio-Thera”), a commercial-stage biopharmaceutical
company developing a pipeline of innovative therapies and biosimilars, today announced
that it has entered into an exclusive commercialization and license agreement
with Dr. Reddy’s Laboratories Ltd. (BSE: 500124 | NSE: DRREDDY | NYSE: RDY |
NSEIFSC: DRREDDY, along with its subsidiaries hereafter referred to as “Dr.
Reddy’s”), for BAT2306, a proposed biosimilar candidate to Cosentyx®
(secukinumab).
Under the terms of the agreement, Bio-Thera
will be responsible for developing, manufacturing, and the supply of BAT2306. Dr.
Reddy’s will be responsible for seeking regulatory approvals and commercialization
in the licensed territories of Southeast Asia, including Brunei, Cambodia,
Indonesia, Laos, Malaysia, Myanmar, Philippines, Thailand and Vietnam.
“Bio-Thera is proud to expand its partnership
with Dr. Reddy’s in Southeast Asia”, said Bert Thomas, Senior Vice President of
Business Development of Bio-Thera. “It is important to bring biosimilars to
patients in Southeast Asia to increase access to innovative therapeutics at an
affordable price and Dr. Reddy’s strong market presence in the region will
maximize patient access to our biosimilar.”
M.V. Ramana, CEO – Branded Markets (India
& Emerging Markets), Dr. Reddy’s, said: “Our extended partnership with
Bio-Thera reaffirms our commitment toward advancing high-impact therapeutic
solutions. The collaboration on Secukinumab marks another step in expanding our
biosimilar presence across Emerging Markets and improving access to advanced
treatments for patients worldwide.”
About BAT2306 (Secukinumab)
Secukinumab is a human IgG1κ monoclonal
antibody that binds to the protein interleukin (IL)-17A.
In the US, secukinumab is prescribed for the
following indications: 1) moderate to severe plaque psoriasis (PsO) in patients
6 years and older who are candidates for systemic therapy or phototherapy, 2)
active psoriatic arthritis (PsA) in patients 2 years of age and older, 3)
adults with active ankylosing spondylitis (AS), 4) adults with active
non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of
inflammation, 5) active enthesitis-related arthritis (ERA) in pediatric
patients 4 years of age and older, 6) adults with moderate to severe
hidradenitis suppurativa (HS).
In EU, secukinumab is used to treat the
following conditions: 1) moderate to severe plaque psoriasis in adults who are candidates
for systemic therapy, 2) moderate to severe plaque psoriasis in children and adolescents
from the age of 6 years who are candidates for systemic therapy, 3) active
moderate to severe hidradenitis suppurativa (acne inversa) in adults with an
inadequate response to conventional systemic HS therapy, 4) active psoriatic arthritis in adult patients when the
response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate, 5) Axial
spondyloarthritis (axSpA), 6) active ankylosing spondylitis in adults who have
responded inadequately to conventional therapy, 7) active non-radiographic
axial spondyloarthritis with objective signs of inflammation as indicated by
elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI)
evidence in adults who have responded inadequately to non-steroidal anti-inflammatory
drugs (NSAIDs), 8) Juvenile idiopathic arthritis (JIA), 9) active enthesitis-related
arthritis in patients 6 years and older whose disease has responded
inadequately to, or who cannot tolerate, conventional therapy, 10) active juvenile
psoriatic arthritis in patients 6 years and older whose disease has responded
inadequately to, or who cannot tolerate, conventional therapy.
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 m.eyineng.com/en/ or follow us on X
@bio_thera_sol) and WeChat (Bio-Thera).
About Dr. Reddy’s
Dr. Reddy’s Laboratories Ltd. (BSE: 500124,
NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company
headquartered in Hyderabad, India. Established in 1984, we are committed to
providing access to affordable and innovative medicines. Driven by our purpose
of ‘Good Health Can’t Wait’, we offer a portfolio of products and services including
APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic
areas of focus are gastrointestinal, cardiovascular, diabetology, oncology,
pain management and dermatology. Our major markets include – USA, India, Russia
& CIS countries, China, Brazil and Europe. As a company with a history of
deep science that has led to several industry firsts, we continue to plan ahead
and invest in businesses of the future. As an early adopter of sustainability
and ESG actions, we released our first Sustainability Report in 2004. Our
current ESG goals aim to set the bar high in environmental stewardship; access
and affordability for patients; diversity; and governance. For more
information, log on to: www.drreddys.com.
Disclaimer: This press release may include
statements of future expectations and other forward-looking statements that are
based on the management’s current views and assumptions and involve known or
unknown risks and uncertainties that could cause actual results, performance or
events to differ materially from those expressed or implied in such statements.
In addition to statements which are forward-looking by reason of context, the
words "may", "will", "should", "expects",
"plans", "intends", "anticipates",
"believes", "estimates", "predicts",
"potential", or "continue" and similar expressions identify
forward-looking statements. Actual results, performance or events may differ
materially from those in such statements due to without limitation, (i) general
economic conditions such as performance of financial markets, credit defaults ,
currency exchange rates, interest rates, persistency levels and frequency /
severity of insured loss events, (ii) mortality and morbidity levels and
trends, (iii) changing levels of competition and general competitive factors,
(iv) changes in laws and regulations and in the policies of central banks
and/or governments, (v) the impact of acquisitions or reorganization, including
related integration issues, and (vi) the susceptibility of our industry and the
markets addressed by our, and our customers’, products and services to economic
downturns as a result of natural disasters, epidemics, pandemics or other
widespread illness, including coronavirus (or COVID-19), and (vii) other risks
and uncertainties identified in our public filings with the Securities and
Exchange Commission, including those listed under the "Risk Factors"
and "Forward-Looking Statements" sections of our Annual Report on
Form 20-F for the year ended March 31, 2025. The company assumes no obligation
to update any information contained herein.
Bio-Thera Cautionary Note Regarding
Forward-Looking Statements
This news release contains certain
forward-looking statements relating to BAT2306 or the product pipelines in
general 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. 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.
Cosentyx® is a registered trademark of Novartis