• The clinical comparative study met its primary endpoint and showed similar efficacy and comparable safety profile in patients with moderate to severe plaque psoriasis

GUANGZHOU, China, November 29, 2023 /PRNewswire/ -- Bio-Thera Solutions, Ltd. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of biosimilars and innovative assets, today announced results from the Phase 3 study of BAT2206, a proposed biosimilar referencing Stelara? (ustekinumab). The primary endpoint of this study was improvement from baseline in Psoriasis Area and Severity Index (PASI) score to Week 12, demonstrating BAT2206 is highly similar with Stelara? in patients with moderate to severe plaque psoriasis.

In the US, Stelara? is currently approved for the treatment of patients 6 years or older with active psoriatic arthritis (PsA), the treatment of patients 6 years or older with moderate to severe plaque psoriasis (Ps) who are candidates for phototherapy or systemic therapy, the treatment of moderately to severely active Crohn’s disease (CD) in adults, and the treatment of moderately to severely active ulcerative colitis (UC) in adults.

The BAT2206 clinical trial was a global, multicenter, randomized, double-blind, parallel-arm, Phase 3 study designed to compare the efficacy, safety, immunogenicity and PK of BAT2206 with Stelara? in 556 patients with moderate to severe plaque psoriasis. More information regarding the BAT2206 Phase 3 clinical trial, including inclusion and exclusion criteria and primary and secondary outcome measures, can be found here: https://clinicaltrials.gov/study/NCT04728360  Results of the study will be presented in a future medical meeting or publication.

“We are pleased to report on our fourth proposed biosimilar with positive Phase 3 study results. These results demonstrate the potential of our proposed ustekinumab biosimilar to be a safe and effective treatment,” said Shengfeng Li, Ph.D., chief executive officer at Bio-Thera Solutions. “Bio-Thera is committed to increasing patient access to innovative medicines through the development of high-quality biosimilars.”

“I’m very pleased to have participated in the successful global Phase 3 study of BAT2206,” commented professor Min Zheng, leading investigator for global phase 3 study of BAT2206.  “BAT2206 will provide a new affordable treatment option for global patients in need. Congratulations to Bio-Thera Solutions."

Bio-Thera entered into a commercialization and license agreement with Hikma for BAT2206 in August 2021. Developed by Bio-Thera, BAT2206 will be commercialized by Hikma in the United States of America. 

About BAT2206 (ustekinumab)

BAT2206 is a proposed biosimilar to Janssen’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. 

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 three approved products, QLETLI?, POBEVCY? and BAT1806 in China and one approved product, TOFIDENCETM (BAT1806), in the USA.  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 dgbaidugoogle.cn/en/or follow us on LinkedIn, X (@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 those associated with 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. POBEVCY? is a registered trademark of Bio-Thera Solutions, Ltd.
4. TOFIDENCETM is a trademark of Biogen, Inc.