Bio-Thera Solutions, Ltd. (688177.SH, “Bio-Thera”) and Intract Pharma (“Intract”) announced a global collaboration and licensing agreement that gives Bio-Thera access to Intract’s Soteria® and Phloral® drug delivery technologies to develop novel oral monoclonal antibody (mAb) treatments for chronic gastrointestinal (GI) inflammatory diseases. Bio-Thera is a global pharmaceutical company developing innovative therapeutics and biosimilars for oncology, autoimmune diseases, cardiovascular diseases, and other serious unmet medical needs.

Under the terms of the agreement, Intract has granted Bio-Thera a worldwide license to Intract’s oral biologics drug delivery platform for a single undisclosed mAb product. Intract will receive an undisclosed upfront payment, with potential development and commercial milestone payments along with royalties on product sales. Intract will lead preclinical research of the product and Bio-Thera will have the option to expand development of the product for multiple GI indications and will be responsible for manufacturing and commercialization of any approved products.

Intract’s oral biologics delivery platform includes Soteria® a technology which protects proteins such as mAbs from degradation in the intestinal lumen. The platform also includes Phloral®, a clinically- validated technology that utilizes both pH and the enzymes produced by colonic bacteria as a trigger mechanism to allow accurate release of payloads in the colon, a suitable site in the GI tract for targeting of biologics for local and systemic delivery.

“Developing oral biologics is the next step in advancing compliance and access to innovative monoclonal antibodies for chronic diseases,” said Dr. Shengfeng Li, CEO of Bio-Thera Solutions. “We believe that combining Bio-Thera’s antibody expertise with Intract’s oral delivery platform will lead to a great advance in the treatment of gastrointestinal disease.”

“Intract Pharma is delighted to be partnering with Bio-Thera to address the significant challenge of delivering powerful biologics orally” said Dr Bill Lindsay, CEO of Intract. “We believe that our technologies will allow development of a more effective therapeutic for the treatment of IBD, while also increasing drug safety and reducing cost.”

About Bio-Thera Solutions, Ltd.

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 stage clinical or entering clinical studies, including differentiated and innovative anti-OX40, anti-TIGIT, and anti-PD-L1/CD47 bispecific antibodies. For more information, please visit www.bio-thera.com/en/ or follow us on Twitter (@bio_thera_sol) and WeChat (Bio-Thera).

About Intract Pharma

Intract Pharma is a biotechnology company bringing disruptive oral biologics delivery solutions to significantly improve the efficacy and safety of emerging and established biotherapeutics and improve patient experience and outcome. The platform leverages the advantage of delivering large proteins/antibodies to the colon, while also protecting the molecules from enzymatic breakdown, allowing tissue/systemic uptake to create next generation oral biologic medicines. For more information visit us at www.intractpharma.com.

Bio-Thera Solutions Cautionary Note Regarding Forward-Looking Statements

This news release contains certain forward-looking statements relating to Bio-Thera Solutions’ collaboration with Intract or product pipelines in general. 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.

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