Guangzhou, China– July 25, 2024 – Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced that dosing has recently begun in an integrated Phase I / Phase III clinical study for BAT3306, a proposed biosimilar of Keytruda® (pembrolizumab).  The clinical study is a randomized, double-blind, parallel group, active control study to compare the pharmacokinetics, efficacy and safety of BAT3306 to Keytruda® in non-squamous non-small cell lung cancer (nsNSCLC) patients.  The study is expected to enroll approximately 676 patients. 

“Keytruda is the most important innovative cancer therapy currently in use” said Shengfeng Li, CEO at Bio-Thera. “Bio-Thera is committed to expanding access to this important cancer therapy with the development of BAT3306.”

Bio-Thera Solutions is developing a large pipeline of biosimilars that include BAT1806, a tocilizumab has been approved by FDA, EMA and NMPA, BAT1706, a bevacizumab has been approved by FDA and NMPA. BAT2206, a ustekinumab has been filed with FDA, EMA and NMPA.  Bio-Thera Solutions is also pursuing biosimilar versions of golimumab, secukinumab, and mepolizumab.

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, TOFIDENCE™/ BAT1806 in the US, EU and China and Avzivi® / Pobevcy® (BAT1706) 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.mjtiyu.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 BAT3306 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. Keytruda® is a registered trademark of Merck Sharp & Dohme

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.