2025-01-16

Bio-Thera Solutions, a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars has signed an exclusive License and Commercialisation Agreement with World Medicine, Türkiye's pharmaceutical export champion, continuing its mission of providing accessible and effective healthcare products worldwide. BAT2206 (Ustekinumab) is a proposed biosimilar to Janssen’s Stelara®. Bio-Thera has submitted marketing authorization applications for BAT2206 to the China National Medical Products Administration (NMPA), the European Medicines Agency (EMA), and the U.S. Food and Drug Administration (FDA).

Under this Agreement, BAT2206 manufactured in China will be introduced to the Turkish market by World Medicine. This collaboration will leverage World Medicine's strong local presence and expertise in sales and marketing in Türkiye. As part of the agreement, World Medicine will hold the marketing authorization for BAT2206 in Türkiye and will be responsible for the product's registration, importation, promotion and commericialsation. Meanwhile, Bio-Thera will manage the manufacturing of BAT2206 in its Guangzhou facilities, handle the commercial supply.

Through this strategic collaboration with Bio-Thera Solutions, World Medicine aims to offer more advanced and effective treatment options for Crohn's disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis, while improving the quality of life for patients. This agreement introduces a new treatment alternative for adult patients with moderate to severe Crohn's disease and other autoimmune conditions who have not responded adequately to conventional treatments, cannot tolerate them, or have contraindications to such therapies.

Commenting on this collaboration, World Medicine Chairman of the Board Ruşen Kalender stated:"Since our inception, World Medicine has been committed to improving lives with our extensive product portfolio. Our collaboration with Bio-Thera Solutions is a natural outcome of this commitment. With this partnership, we have taken a significant step towards providing sustainable healthcare solutions and making critical treatments like Ustekinumab accessible to patients in Türkiye."

Dr. Shengfeng Li, CEO of Bio-Thera, added:"Bio-Thera is pleased to partner with World Medicine to commercialize our Ustekinumab biosimilar in Türkiye. We look forward to working with World Medicine to bring this important biosimilar to patients in Türkiye."

About BAT2206 (Ustekinumab)

BAT2206 is a proposed biosimilar of Janssen's Stelara®, a human monoclonal antibody that inhibits the biological activity of IL-12 and IL-23 cytokines by preventing their shared p40 subunit from binding to the IL-12Rβ1 receptor on immune cell surfaces.

IL-12 and IL-23 play key roles in inflammatory and immune responses, particularly in the activation of natural killer (NK) cells and the differentiation and activation of CD4+ T-cells. These cytokines have been identified as significant contributors to chronic inflammation, which is a hallmark of Crohn's disease and ulcerative colitis, among other autoimmune diseases.
 

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 four approved products: QLETLI® and BETAGRIN®(Bevifibatide Citrate Injection) in China, and TOFIDENCE/ BAT1806 and Avzivi® / Pobevcy® in the US, 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 ADCs. For more information, visit: www.bio-thera.com/en/ or follow on Twitter (@bio_thera_sol), and LinkedIn (in/bio-thera-solutions-ltd), and  WeChat (Bio-Thera).

About World Medicine

Established in 2011 in Türkiye, World Medicine İlaç Sanayi ve Ticaret A.Ş. is dedicated to improving quality of life by providing accessible and effective pharmaceutical products worldwide, driven by sustainable quality standards and innovative approaches.World Medicine has been Türkiye’s pharmaceutical export champion for the last three consecutive years and exports its products to over 50 countries. With continuous investments, the company aims to position Türkiye as its primary production hub and central base.The company operates across multiple therapeutic areas, including ophthalmology, neurology, endocrinology, cardiology, rheumatology, gastroenterology, urology, and pulmonology, with a diverse portfolio exceeding 500 pharmaceutical products. World Medicine continues its efforts to be a reliable business partner and a leading pharmaceutical company in all markets where it operates. For more information, visit: www.worldmedicine.com.tr/en/ or follow on X (@worldmedicinetr) and LinkedIn (in/worldmedicineturkiye).

Cautionary Note Regarding Forward-Looking Statements

This news release contains certain forward-looking statements relating to BAT2206, 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.

1. QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd.

2. BETAGRIN® is a registered trademark of Bio-Thera Solutions, Ltd.

2. TOFIDENCETM is a trademark of Biogen MA, Inc.

3. AVZIVI® is a registered trademark of Sandoz AG

4. POBEVCY® is a registered trademark of Bio-Thera Solutions, Ltd.