GUANGZHOU, China ---(Businesswire)--- Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and a pipeline of biosimilars, today announced the company has entered into a licensing and supply agreement with Biomm SA, for BAT2206, its ustekinumab biosimilar, under which Biomm will have exclusive rights to distribute and market the drug in Brazil.  Bio-Thera and Biomm’s partnership was initiated around a licensing and supply agreement for Biomm to distribute and market BAT1706, a bevacizumab biosimilar, in Brazil.

BAT2206 is a proposed biosimilar to Janssen’s Stelara®1, which is currently approved in Brazil  for the treatment of active psoriatic arthritis (PsA) in adults, alone or in combination with methotrexate; the treatment of patients 6 years or older with moderate to severe plaque psoriasis who have not responded, or who have a contraindication, or who are intolerant to other systemic therapies, including cyclosporine, methotrexate and ultraviolet A radiation associated with psoralen administration ( PUVA ), for the treatment of adult patients with moderate to severe active Crohn's disease, who have had an inadequate response, loss of response or who have been intolerant to conventional therapy or anti-TNF-alpha or who have contraindications for such therapies and or the treatment of adult patients with moderate to severe active ulcerative colitis, who had an inadequate response, loss of response or who have been intolerant to conventional therapy or therapy with biological drugs or who have contraindications for such therapies.

Bio-Thera’s BAT2206 has completed a Phase I study and is currently being evaluated in a global Phase III clinical study, which includes patients from China and Eastern European countries. Bio-Thera intends to file for regulatory approval with the China National Medical Products Administration (NMPA), the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA). Biomm will be responsible for filing the dossier in Brazil.

This partnership will leverage Biomm’s strong local presence, sales and marketing capabilities in Brazil. Bio-Thera will be responsible for completing global development and commercial supply of BAT2206 out of its manufacturing facilities in Guangzhou, China.

“Bio-Thera is pleased to expand our partnership with Biomm to commercialize our ustekinumab biosimilar program in Brazil”, said Dr. Shengfeng Li, CEO of Bio-Thera.  “By expanding our partnership with Biomm, Bio-Thera is doubling its commitment to providing Brazilian patients with increased access to important biotherapeutics at affordable prices.”

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 and eye diseases, and other severe and emerging 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. In addition, the company has 25 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).

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 high in vitro affinity may not translate to desired results in vivo or successful 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. POBEVCY® is a registered trademark of Bio-Thera Solutions, Ltd.

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

June 16, 2023