Bio-Thera Solutions Announces Commercialization and License Agreement for BAT1706, a Proposed Biosimilar Referencing Avastin� (Bevacizumab)

GUANGZHOU, China–(BUSINESS WIRE)–#Avastin–Bio-Thera Solutions, Ltd. (688177.SH) today announced that it has entered into a commercialization and license agreement with Sandoz to commercialize BAT1706, an anti- vascular endothelial growth factor (VEGF) monoclonal antibody that is a proposed biosimilar referencing AVASTIN^� (bevacizumab). BAT1706 has completed extensive biosimilar studies, including a global Phase III study, and BLAs were filed with NMPA, FDA and EMA in 2020.

Under the agreement, Bio-Thera will maintain responsibilities for development, manufacturing, and supply of BAT1706. Sandoz will commercialize the medicine in all markets covered by the agreement upon regulatory approval. The license covers the US, Europe, Canada and a majority of the remaining international markets that are not covered under other BAT1706 partnerships. Bio-Thera will receive an upfront payment, potential milestone payments along with royalties on product sales.

“Bio-Thera Solutions is happy to enter this agreement with a global biosimilar leader to bring BAT1706, our bevacizumab biosimilar, to patients around the world,” said Dr. Shengfeng Li, CEO of Bio-Thera Solutions. “Biosimilars are an important aspect of Bio-Thera Solutions corporate strategy and a critical to increasing patient access to innovative products like bevacizumab.”

BAT1706 is a proposed bevacizumab biosimilar developed by Bio-Thera. Bevacizumab is a humanized monoclonal antibody that targets VEGF. It can specifically bind to VEGF and block the binding of VEGF to its receptor, thereby reducing neovascularization, inducing the degradation of existing blood vessels, and thereby inhibiting tumor growth. The reference medicine bevacizumab has been approved in United States and Europe for several indications including advanced, metastatic, or recurrent non-small cell lung cancer, metastatic colorectal cancer and certain types of renal cell carcinoma, ovarian cancer, cervical cancer, and glioblastoma.

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® (???®), 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).

Bio-Thera Solutions Cautionary Note Regarding Forward-Looking Statements

This news release contains certain forward-looking statements relating to BAT1706 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.

* Avastin® is a registered trademark of Genentech, Inc.

* QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd.

* ???® is a registered trademark of Bio-Thera Solutions, Ltd.

Contacts

Bio-Thera Solutions Media
Bert E. Thomas IV

Senior Vice President, Business Development

+1 410 627 1734 (mobile)

bethomas@bio-thera.com