Bio-Thera Solutions and Intract Pharma Sign Global Collaboration and License Agreement for Soteria® and Phloral® Drug Delivery Technologies to Enable Oral Antibody Drug Development

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GUANGZHOU, China – (COMMERCIAL THREAD) – 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 Soteria® and Phloral® drugs from Intract technologies d administration to develop novel oral monoclonal antibody (mAb) therapies for chronic gastrointestinal (GI) inflammatory disease. Bio-Thera is a global pharmaceutical company developing innovative therapies and biosimilars for oncology, autoimmune disease, cardiovascular disease and other serious unmet medical needs.

Under the terms of the agreement, Intract has granted Bio-Thera a worldwide license for Intract’s oral biologic drug delivery platform for a single undisclosed mAb product. Intract will receive an undisclosed upfront payment, with potential payments for development and business milestones as well as royalties on product sales. Intract will lead the preclinical research of the product and Bio-Thera will have the opportunity to expand product development for multiple GI indications and will be responsible for the manufacture and marketing of any approved product.

Intract’s oral biologics delivery platform includes Soteria®, a technology that protects proteins such as mAbs from degradation in the intestinal lumen. The platform also includes Phloral®, a clinically validated technology that uses both pH and enzymes produced by colon bacteria as a triggering mechanism to enable precise release of payloads into the colon, a suitable site in the colon. gastrointestinal tract for targeting biologics for and systemic delivery.

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

“Intract Pharma is delighted to partner with Bio-Thera to meet the daunting challenge of delivering potent oral biologics,” said Dr. Bill Lindsay, CEO of Intract. “We believe that our technologies will allow the development of a more effective therapy for the treatment of IBD, while increasing drug safety and reducing costs. ”

About Bio-Thera Solutions, Ltd.

Bio-Thera Solutions, Ltd., a leading commercial-stage biopharmaceutical company in Guangzhou, China, is dedicated to the research and development of new therapies for the treatment of cancer, autoimmune, cardiovascular and disease. other serious unmet medical needs, as well as biosimilars for existing brand name biologics to treat a range of cancers and autoimmune diseases. As a leader in next-generation antibody discovery and engineering, the company has advanced six candidates in advanced clinical trials and one of them, QLETLI® (格 子 立 ®), a biosimilar to adalimumab, is available for patients in China. In addition, the company has several candidates in clinical studies or undergoing early-stage clinical studies, including differentiated and innovative bispecific anti-OX40, anti-TIGIT and anti-PD-L1 / CD47 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 that provides disruptive oral biologic delivery solutions to dramatically improve the efficacy and safety of emerging and established biotherapeutics and improve patient experience and outcomes. The platform takes advantage of the advantage of delivering large proteins / antibodies to the colon, while protecting molecules from enzymatic degradation, enabling tissue / system uptake to create next-generation oral biologics. For more information, visit us at www.intractpharma.com.

Caution from Bio-Thera Solutions Regarding Forward-Looking Statements

This press 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 forward-looking statements involves known and unknown risks and uncertainties. Forward-looking statements include, among others, those containing “could”, “could”, “should”, “will”, “would”, “anticipate”, “believe”, “plan”, “promising”, “potentially”, Or similar expressions. They reflect the current views of the company regarding future events which are based on what the company considers reasonable assumptions in view of the information currently available to Bio-Thera Solutions and do not constitute a guarantee of future performance or developments. Actual results and events may differ materially from information contained in forward-looking statements due to a number of factors, including, but not limited to, the risks and uncertainties inherent in pharmaceutical research and development, such as that the uncertainties of and clinical studies, for example, developmental processes may be lengthy and the results of in vitro or early small-scale clinical trials may not translate into the desired results in vivo or in large-scale clinical studies. ladder. Other risks and uncertainties include challenges in obtaining regulatory approvals, manufacturing, marketing, competition, intellectual property, product efficacy or safety, changes in the global situation health care, changes in the financial conditions of the business and changes in applicable laws and regulations, etc. the forward-looking statements contained in this document are made only as of the date of their initial publication. Unless required by laws or regulations, Bio-Thera Solutions assumes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, changes in company views or otherwise.



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