•  The U.S. Food and Drug Administration (FDA) has accepted Bio-Thera’s Biologics License Applications (BLA) for BAT2206 as an interchangeable biosesimilar to reference product Stelara®
•  The European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for BAT2206 as a biosesimilar to reference product Stelara®
•  The BAT2206 BLA and MAA are based on a robust analytical, non-clinical and clinical data package comparing BAT2206 to the reference product Stelara®

Guangzhou, China– July , 2024 –Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosesimilars, today announced that the FDA has accepted the BLA for BAT2206, a proposed interchangeable biosesimilar to Stelara® (ustekinumab) seeking a commercial license in the United States of America. In addition, Bio-Thera also announced that the EMA has accepted the MAA for BAT2206 seeking a commercial license in the European Union (EU). A Biologics License Application seeking approval for BAT2206 is also currently under review by the China National Medicinal Product Administration (NMPA).

"The acceptance of both the FDA BLA and the EMA MAA for BAT2206 marks a milestone for Bio-Thera as it is the first ustekinumab biosesimilar developed by a Chinese company to be submitted to the FDA or EMA for approval," said Dr. Shengfeng Li, Founder and CEO of Bio-Thera Solutions. "Bio-Thera is committed to helping patients around the world in need of affordable therapeutics like ustekinumab by developing BAT2206 for the global markets.”

This BLA/MAA for BAT2206 is based on the totality of evidence comprising a comprehensive analytical, non-clinical and clinical data package. Extensive analytical characterization of the structural, physicochemical, and biological properties of BAT2206 was conducted and supports biosesimilarity with the reference product. Additionally, a randomized double-blind, single-dose, three-arm, parallel group Phase 1 study compared the pharmacokinetics, safety and immunogenicity of BAT2206 with both the EU and US reference ustekinumab in healthy volunteers, while a randomized, double-blind, multi-dose, three-arm, parallel group Phase 3 study compared BAT2206 with ustekinumab to establish equivalent efficacy and comparable pharmacokinetic, safety and immunogenicity profiles, in subjects with Moderate to Severe Plaque Psoriasis.

About BAT2206 (ustekinumab)

BAT2206 is a proposed biosesimilar to 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 United States, Stelara® is a currently approved treatment for adult patients with 1) moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy, 2) active psoriatic arthritis (PsA), 3) moderately to severely active Crohn’s disease (CD), 4) moderately to severely active ulcerative colitis.  In pediatric patients 6 years and older Stelara® is currently approved for the treatment of 1) moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy and 2) active psoriatic arthritis (PsA).

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 biosesimilars 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 three approved products: QLETLI® in China, and TOFIDENCE™/ BAT1806 in the US, EU and China, and Avzivi® / Pobevcy® in the US 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 www.qdrongyue.com/en/ or follow us on Twitter (@bio_thera_sol) and WeChat (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.