Bio-Thera Solutions Announces the First Patient Dosed in Phase III Clinical Trial for BAT2206, a Proposed Biosimilar of Stelara® (Ustekinumab)

Bio-Thera Solutions, Ltd. (688177.SH), a commercial-stage pharmaceutical company, today announced that the first patient has been dosed in a Phase III clinical study for BAT2206, a proposed biosimilar of Stelara® (ustekinumab). The clinical study is a multicenter, randomized, double-blind, and parallel controlled study to compare the efficacy and safety of BAT2206 to Stelara® in moderately to severely psoriatic (PsO) patients that is expected to enroll approximately 472 volunteers. In the U.S. and the European Union, Stelara® is approved for moderately to severely psoriatic (PsO), active psoriatic arthritis (PsA), Crohn’s disease (CD) and active ulcerative colitis (UC).

Ustekinumab 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 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. “BAT2206 is Bio-Thera's fourth biosimilar to enter a global phase III clinical study,” commented Dr. Shengfeng Li, Founder and CEO of Bio-Thera Solutions. “The advancement of BAT2206 into a global Phase III study demonstrates Bio-Thera’s continued commitment to developing biosimilars of important innovative drugs to expand patient access at lower costs.”

Bio-Thera Solutions is developing several additional proposed biosimilars, including a bevacizumab biosimilar and a tocilizumab biosimilar that have both successfully completed global Phase III clinical trials. Bio-Thera Solutions is also pursuing biosimilar versions of golimumab, mepolizumab and dupilumab.

About Bio-Thera Solutions

Bio-Thera Solutions, Ltd., a leading commercial-stage biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular diseases, and other serious unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. As a leader in the next generation antibody discovery and engineering, the company has advanced six candidates into late-stage clinical trials and one of which, QLETLI® (格乐立®), a biosimilar to adalimumab, is available to patients in China. In addition, the company has multiple candidates in early clinical trials and IND-enabling studies, including differentiated and innovative anti-OX40, anti-TIGIT antibodies. For more information, please visit www.bio-thera.com/en/ or follow us on Twitter (@bio_thera_sol), LinkedIn (https://www.linkedin.com/company/bio-thera-solutions-ltd) and WeChat (Bio-Thera).

Bio-Thera Solutions 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, for example, the development processes could be lengthy and in vitro or early, small scale clinical trial results may not translate into desired results in vivo or in large scale 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 格乐立® is a registered trademark of Bio-Thera Solutions, Ltd.

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