China NMPA Approves Bio-Thera Solutions’ BAT1806, A Biosimilar to Actemra® (Tocilizumab)

World’s First Approved Biosimilar to Actemra®

GUANGZHOU, China–(BUSINESS WIRE)–#Actemra–Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage biopharmaceutical company, announced that the China National Medical Products Administration (NMPA) has approved BAT1806, a biosimilar of Actemra^® (tocilizumab), in China. BAT1806 is the first tocilizumab biosimilar approved by the NMPA or any other regulatory agency around the world and has been approved for the treatment of rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis (sJIA), and cytokine release syndrome (CRS). BAT1806 is Bio-Thera Solutions’ third biosimilar to receive regulatory approval by the NMPA.

BAT1806, a tocilizumab injection developed by Bio-Thera Solution in accordance with the biosimilar guidelines of China’s NMPA, the U.S. Food and Drug Administration (FDA), and the European Medicines Agency (EMA), is a recombinant humanized monoclonal antibody targeting interleukin-6 receptor (IL-6R), which specifically binds to soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R) and inhibits signaling mediated by sIL-6R or mIL-6R. The marketing authorization application for BAT1806/BIIB800 has been accepted by EMA and FDA. The reference product, Actemra^®, has been approved in the United States for the treatment of rheumatoid arthritis (RA), giant cell arthritis (GCA), systemic sclerosis-associated interstitial lung disease (SSc-ILD), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA), cytokine release syndrome (CRS), and coronavirus disease 2019 (COVID-19). Comprehensive analytical similarity studies, non-clinical similarity studies and clinical studies have confirmed that BAT1806 is highly similar to the reference drug in terms of quality, safety and efficacy.

Dr. Shengfeng Li, Founder and CEO of Bio-Thera Solution said, “We are delighted that BAT1806 has been approved as the world’s first tocilizumab biosimilar. This is a very important step for Bio-Thera in the field of rheumatology, and it is more important to patients as its approval provides a new treatment option to many patients with autoimmune conditions.” Dr. Li continues, “China is currently facing an unprecedented spread of the COVID-19 infections, and BAT1806 provides a treatment option to many hospitalized COVID-19 patients with severe lung conditions”.

Bio-Thera Solutions is developing several additional biosimilar products, including proposed biosimilars for Simponi^®, Stelara^® and Cosentyx^®, which are all currently in global Phase 3 studies, and a proposed biosimilar for Nucala^®, which is currently in a Phase 1 study.

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 and eye diseases, and other severe and emerging 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^®, POBEVCY^® and BAT1806 in China. In addition, the company has 25 promising candidates in clinical trials, focusing on immuno-oncology in the post-PD-1 era and targeted therapies such as antibody drug conjugates (ADC). For more information, please visit www.bio-thera.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 BAT1806 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 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.

Contacts

Bio-Thera Solutions, Ltd.:

Bert E. Thomas IV +1.410.627.1734

[email protected]