GUANGZHOU, China and San José, Costa Rica - Bio-Thera Solutions, a commercial-stage biopharmaceutical company developing innovative therapies and biosesimilars, and SteinCares, one of Latin America’s leading specialty healthcare companies, announced today a new licensing agreement for two biosesimilars under which SteinCares will have exclusive rights to distribute and market Bio-Thera’s pharmaceuticals in Brazil and the rest of the region.

Bio-Thera is responsible for completing the development of each biosesimilar and for regulatory filing with FDA and EMA that will support regulatory filings in the LATAM region.  The company will also be liable for the commercial supply of the biosesimilars out of its manufacturing facilities in Guangzhou, China.  SteinCares' extensive experience and understanding of the Latin American healthcare system will ensure an optimal go-to-market strategy and maximize product access in the region. This partnership will leverage SteinCares’ strong local presence, and sales and marketing capabilities in the region.

“Partnering with Bio-Thera represents a step forward in our mission to create healthcare opportunities for patients in Latin America. This alliance strengthens our position as regional leaders in biosesimilars, with seven products already launched in this market, making us the preferred partner for global biotech and pharmaceutical companies entering the Latin American market. Together, we are committed to helping patients access safe, innovative, and affordable treatments, while upholding the highest ethical standards,” said Mitchell Waserstein, CEO of SteinCares.

“Bio-Thera is pleased to partner with SteinCares to commercialize the two biosesimilars in Brazil and LATAM,” said Dr. Shengfeng Li, CEO of Bio-Thera. “We look forward to bringing these important products to patients in Central and South America in collaboration with SteinCares.”

About SteinCares

SteinCares is a leader in commercializing and distributing specialty healthcare products in Latin America, including innovative pharmaceuticals, biosesimilars and complex generics. With over 40 years of progressive healthcare experience and presence in more than 30 countries in Latin America and the Caribbean, SteinCares serves as a bridge between global pharmaceutical companies and the region’s healthcare providers. The company is deeply committed to creating healthcare opportunities that positively impact the lives of patients and their families in Latin America, with a vision of increasing access to innovative and cost-effective healthcare for patients in the region. For more information, please visit www.steincares.com and follow the company on LinkedIn. 

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 biosesimilars 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® in China, and TOFIDENCE™/ BAT1806 and Avzivi®/Pobevcy® in the US 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 www.qdrongyue.com/en/ or follow us on Twitter (@bio_thera_sol) and WeChat (Bio-Thera).

Cautionary Note Regarding Forward-Looking Statements

This news release contains certain forward-looking statements relating to products and businesses 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 high in vitro affinity may not translate to desired results in vivo or successful 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. QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd.

2. TOFIDENCETM is a trademark of Biogen MA, Inc.

3. AVZIVI® is a registered trademark of Sandoz AG

4. POBEVCY® is a registered trademark of Bio-Thera Solutions, Ltd.