China Approves Revolutionary Biosimilar to Actemra®, Providing Hope to Patients Everywhere

World’s First Approved Biosimilar to Actemra®

Bio-Thera Solutions, Ltd., a commercial-stage biopharmaceutical company based in Guangzhou, China, has just made a major breakthrough in medical history. The China National Medical Products Administration (NMPA) has approved BAT1806, a biosimilar of Actemra® (tocilizumab). This is the world’s first tocilizumab biosimilar to receive regulatory approval by the NMPA or any other regulatory agency, and it is now available for the treatment of rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis (sJIA), and cytokine release syndrome (CRS). Bio-Thera Solutions’ third biosimilar to receive NMPA approval, BAT1806 is set to revolutionize the world of biopharmaceuticals.

Bio-Thera Solution’s BAT1806, an injection of tocilizumab, has been developed in accordance with the biosimilar guidelines of China’s NMPA, the U.S. Food and Drug Administration (FDA), and the European Medicines Agency (EMA). This powerful recombinant humanized monoclonal antibody directly targets interleukin-6 receptor (IL-6R) and effectively inhibits the signaling mediated by sIL-6R or mIL-6R. The marketing authorization application for BAT1806/BIIB800 has already been accepted by the EMA and FDA, making it a viable alternative to Actemra® for the treatment of various conditions such as 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 even coronavirus disease 2019 (COVID-19). In addition, thorough analytical similarity studies, non-clinical similarity studies, and clinical studies have all validated the high degree of similarity between BAT1806 and the reference drug in terms

We are thrilled to announce that BAT1806 has been approved as the world’s first tocilizumab biosimilar, providing a new treatment option to many patients with autoimmune conditions, as well as those hospitalized with severe COVID-19 lung conditions. Dr. Shengfeng Li, Founder and CEO of Bio-Thera Solution, acknowledges the significance of this milestone, saying, “This is a very important step for Bio-Thera in the field of rheumatology, and it provides a much-needed treatment option to many patients in these trying times.”

Bio-Thera Solutions is leading the way in the field of rheumatology with their approval of BAT1806, the world’s first tocilizumab biosimilar. Dr. Shengfeng Li, Founder and CEO of Bio-Thera Solutions, is delighted to have this product available to many patients with autoimmune conditions, as well as to those hospitalized for COVID-19 with severe lung conditions. As the global Phase 3 studies of proposed biosimilars for Simponi®, Stelara® and Cosentyx®, and a proposed biosimilar for Nucala® continue, Bio-Thera Solutions is dedicated to providing more treatment options to those in need.

About Bio-Thera Solutions

Bio-Thera Solutions, Ltd. is a pioneering biopharmaceutical company based in Guangzhou, China, leading the charge in the development of groundbreaking therapies for cancer, autoimmune, cardiovascular, and eye diseases. Our team of dedicated scientists and researchers are committed to discovering and engineering innovative treatments for severe and emerging medical needs. Our impressive portfolio features three approved products, QLETLI®, POBEVCY® and BAT1806, along with 25 promising clinical trials in immuno-oncology and targeted therapies such as antibody drug conjugates (ADC).

Cautionary Note Regarding Forward-Looking Statements

Bio-Thera Solutions is proud to introduce its revolutionary new product, BAT1806, to the global healthcare market. With promising potential to revolutionize the treatment of certain conditions, this cutting-edge product is a testament to the company’s commitment to bringing innovative solutions to the medical world. However, while the product has shown great in vitro affinity, the development process is lengthy and uncertain, and the efficacy or safety of the product is not guaranteed. Nonetheless, Bio-Thera Solutions is confident that its research and development will lead to success, and is committed to bringing innovative solutions to the global healthcare market.

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