Bio-Thera Solutions, Ltd.,


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Bio-Thera Solutions Expands Partnership with Dr. Reddy’s through an Exclusive Commercialization and License Agreement for BAT2306, a Proposed Biosimilar Candidate to Cosentyx® (Secukinumab), in Southeast Asia

Date: 2025-11-10Click:

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