GUANGZHOU, China and MOSCOW, Russia --- 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 reached licensing and supply agreements with Pharmapark LLC, for BAT2306, its secukinumab biosimilar, under which Pharmapark will have exclusive rights to distribute and market the drug with a status of a local product in Russia and other CIS countries.  Bio-Thera and Pharmapark’s partnership was initiated around a licensing and supply agreement for BAT2506, a golimumab biosimilar and previously expanded to include BAT2206, an ustekinumab biosimilar.

BAT2306 is a proposed biosimilar to Novartis’ Cosentyx?.  BAT2306 has completed a Phase I study and a global Phase III clinical trial. 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). Pharmapark will be responsible for filing the dossier in Russia and other CIS countries.

This partnership will leverage Pharmapark’s strong local presence, sales and marketing capabilities in Russia and other CIS countries. Bio-Thera will be responsible for full development, and commercial supply of BAT2306 out of its manufacturing facilities in Guangzhou, China.

“Bio-Thera is pleased to expand our partnership with Pharmapark to commercialize our secukinumab biosimilar in Russia and other CIS countries”, said Dr. Shengfeng Li, CEO of Bio-Thera.  “By partnering with Pharmapark, Bio-Thera is demonstrating its commitment to provide increased patient access to innovative biotherapeutics at affordable prices.”

"We are delighted to deepen our partnership with our strategic and reliable partner, Bio-Thera. Pharmapark remains committed to collaborating with top biosimilar developers to ensure the swift introduction of biosimilar products to the Russian and CIS markets. This collaboration reinforces our position as a leading player in the biosimilar market in Russia." said Vyacheslav Lebedyansky, CEO of Pharmapark.

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? (BAT1406) in China, and TOFIDENCE?/ BAT1806 and Avzivi? / Pobevcy? (BAT1706) in the US, EU and China. 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 9izixun.cn/en/ or follow us on Twitter (@bio_thera_sol) and WeChat (Bio-Thera).

About Pharmapark LLC

Pharmapark is a privately-owned Russian biopharmaceutical company that is focused on development, manufacture and commercialization of biosimilar products. The company possesses the know-how and has a successful track record performing complete biotechnological drug development through commercial production. Pharmapark has successfully marketed 8 biosimilar products and has a large pipeline of novel formulations and biosimilars focused on value-adding treatments.

Cautionary Note Regarding Forward-Looking Statements

This news release contains certain forward-looking statements relating to BAT2306 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 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. Cosentyx? is a registered trademark of Novartis AG

2. QLETLI? is a registered trademark of Bio-Thera Solutions, Ltd.

3. TOFIDENCE? is a trademark of Biogen

4. Avzivi? is a registered trademark of Sandoz AG

5. POBEVCY? is a registered trademark of Bio-Thera Solutions, Ltd.