Date: 2024-12-24

Guangzhou, China, December 24, 2024 - Bio-Thera Solutions Inc.(688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and a pipeline of biosimilars, today announced the company has partnered with Tabuk Pharmaceutical Manufacturing Company (a fully-owned subsidiary of Astra Industrial Group), a leading pharmaceutical company in the Middle East and North Africa (MENA) region, for BAT2206, its ustekinumab biosimilar, under which Tabuk will have exclusive rights to manufacture, distribute and market the drug in Saudi Arabia.

BAT2206 is a proposed biosimilar to Jansen’s Stelara®. Bio-Thera has filed for regulatory approval of BAT2206 with the China National Medical Products Administration (NMPA), the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA).

This partnership will leverage Tabuk’s strong local presence, sales and marketing capabilities in Saudi Arabia. Under this agreement Tabuk Pharmaceuticals will hold the marketing authorization and will be responsible to manufacture, register, import, and promote BAT2206 in Saudi Arabia.  Bio-Thera will be responsible for full development, and commercial supply of BAT2206 out of its manufacturing facilities in Guangzhou, China.

“Bio-Thera is pleased to establish a partnership with Tabuk to commercialize our ustekinumab biosimilar program in Saudi Arabia”, said Dr. Shengfeng Li, CEO of Bio-Thera.  “Tabuk is a leading pharmaceutical company in the MENA region and is a great partner to ensure patients in Saudi Arabia have the best access to BAT2206.”

Ismail Shehada, CEO of Tabuk Pharmaceuticals “We are excited to announce our partnership with Bio-Thera that will enable us to deliver unique and specialized health solutions aimed at enhancing the well-being of people in Saudi Arabia. We are confident that this partnership supports our efforts to manufacture and localize biosimilar products in the region and strengthen our market leading position in line with our strategy. This also stands as a commitment from our side to support the 2030 vision of Saudi Arabia through localizing biopharmaceutical products in the Kingdom.”

About BAT2206 (ustekinumab)
BAT2206 is a proposed biosimilar to Jansen's Stelara® which is a human monoclonal antibody that inhibits the bioactivity of human IL-12 and IL-23 by preventing shared p40 from binding to the IL-12Rβ1 receptor protein expressed on the surface of immune cells. IL-12 and IL-23 are involved in inflammatory and immune responses, such as natural killer cell activation and CD4+ T-cell differentiation and activation. IL-12 and IL-23 have been implicated as important contributors to the chronic inflammation that is a hallmark of Crohn's disease and ulcerative colitis, among many other autoimmune diseases.  In the EU, Stelara® is currently approved for the treatment of 1) moderate to severe plaque psoriasis in adults and children above the age of 6 years whose condition has not improved with, or who cannot use, other systemic (whole-body) psoriasis treatments, 2) active psoriatic arthritis, alone or combined with methotrexate, in adults, when the condition has not improved enough with other treatments called disease-modifying anti-rheumatic drugs (DMARDs), 3) moderately to severely active Crohn's disease in adults whose condition has not improved enough with other treatments for Crohn's disease or who cannot receive such treatments, 4) moderately to severely active ulcerative colitis in adults whose condition has not improved enough with other treatments for ulcerative colitis or who cannot receive such treatments.

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, please visit www.bio-thera.com/en/ or follow us on Twitter (@bio_thera_sol) and WeChat (Bio-Thera).

About Tabuk Pharmaceutical Manufacturing Company

Tabuk Pharmaceutical Manufacturing Company is a leading Saudi pharmaceutical company with a regional presence in the Middle East and North Africa. Tabuk Pharmaceuticals develops, manufactures, markets and distributes various branded generics, in addition to manufacturing pharmaceutical products for renowned international partners at its manufacturing sites in Saudi Arabia, as part of its continuous efforts to cover the needs of patients by providing high quality medicines. Tabuk Pharmaceuticals is a major player in the pharmaceutical sector not only in the Kingdom of Saudi Arabia, but also in the Middle East and North Africa, thanks to its four state-of-the-art manufacturing sites located in Tabuk and Dammam in the Kingdom, as well as in Sudan and Algeria, and orchestrated by a team of more than 2,400 employees. Tabuk pharmaceuticals reaches patients in 18 countries in the Middle East and Africa, in addition to futuristic plans to expand its presence in the region.

Bio-Thera 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. Stelara® is a registered trademark of Johnson & Johnson Corporation

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

3. TOFIDENCE™ is a trademark of Biogen

4. Avzivi® is a registered trademark of Sandoz AG

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