GUANGZHOU, China & MOSCOW–(BUSINESS WIRE)–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 BAT2206, its ustekinumab 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 Pharmapark to distribute and market BAT2506, a golimumab biosimilar, in Russia and other CIS countries.
BAT2206 is a proposed biosimilar to Jansen’s Stelara®1 which is currently approved in the U.S. for the treatment of active psoriatic arthritis (PsA) in adults, alone or in combination with MTX, the treatment of patients 6 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, the treatment of moderately to severely active Crohn’s disease in adults, and the treatment of moderately to severely active ulcerative colitis in adults.
Bio-Thera’s BAT2206 has completed a Phase I study and is currently being evaluated in a global Phase III clinical study including patients from China, Russia and other 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). 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 BAT2206 out of its manufacturing facilities in Guangzhou, China.
“Bio-Thera is pleased to expand our partnership with Pharmapark to commercialize our ustekinumab biosimilar program in Russia and other CIS countries”, said Dr. Shengfeng Li, CEO of Bio-Thera. “By expanding our partnership with Pharmapark, Bio-Thera is redoubling its commitment to providing Russian patients with increased access to innovative biotherapeutics at affordable prices.”
“We are extremely happy to expand our collaboration with Bio-Thera. Pharmapark intends to continue to work with the leading biosimilar developers to enable rapid entrance of biosimilar products to the Russian and CIS markets and strengthen our position in Russia as the leading player in the biosimilar market.” said Vyacheslav Lebedyansky, CEO of Pharmapark.
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®2 (格乐立®3), 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/
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 5 biosimilar products and has in-house pipeline of novel formulations and biosimilars focused on value-adding treatments.
Bio-Thera Solutions 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 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.
1. Stelara® is a registered trademark of Johnson & Johnson Corporation
2. QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd.
3. 格乐立® is a registered trademark of Bio-Thera Solutions, Ltd.
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