Bio-Thera's world's first tocilizumab biosimilar was approved for marketing in China

On the evening of January 16, Bio-Thera issued an announcement: the National Medical Products Administration (NMPA) approved the marketing application of Shireli ® (tocilizumab injection) submitted by the company, and the approved indications are rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis (sJIA), and cytokine release syndrome (CRS).

Shiruili ® (code BAT1806) is a tocilizumab injection developed by the company in accordance with the guidelines of China's NMPA, the US Food and Drug Administration (FDA), and the European Medicines Agency (EMA) on biosimilars. Schreli ® is a recombinant humanized monoclonal antibody targeting the interleukin-6 receptor (IL-6R) that specifically binds to soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R) and inhibits signaling mediated by sIL-6R and mIL-6R. Previously, the marketing authorization application of BAT1806/BIIB800 has been accepted by EMA and FDA.

The original drug tocilizumab (Yamero) ® has been approved in China for the treatment of rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis (sJIA) and cytokine release syndrome (CRS); It has been approved abroad for the treatment of rheumatoid arthritis (RA), giant cell arteritis (GCA), systemic sclerosis-related interstitial lung disease (SSc-ILD), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA), cytokine release syndrome (CRS) and novel coronavirus pneumonia (COVID-19). Through comprehensive quality similarity studies, preclinical studies, clinical drug metabolism comparison studies, and clinical efficacy and safety comparison studies, the results show that Shiruili ® is highly similar to the original drug in quality, safety and efficacy.

In recent years, tocilizumab has also been recognized by domestic and foreign regulatory authorities in the treatment of novel coronavirus pneumonia:

In March 2020, tocilizumab was included in China's "Diagnosis and Treatment Plan for Novel Coronavirus Pneumonia (Trial Seventh Edition)" for the first time1, which was used for immunotherapy of severe and critical cases and promoted to the whole country;

In June 2021, the FDA approved tocilizumab as an Emergency Use Authorization for the treatment of patients with severe COVID-19 pneumonia2;

In April 2022, the FDA granted Yamero ® (tocilizu antigen research drug) priority review qualification3;

In December 2022, the FDA officially approved Yamerol ® (tocilizu antigen research drug) for hospitalized adult patients with novel coronavirus infection, becoming the first monoclonal antibody drug officially approved by the FDA for the treatment of new crowns4;

On January 5, 2023, the National Health Commission issued the "Diagnosis and Treatment Plan for Novel Coronavirus Infection (Trial Version 10)"5 once again recommended tocilizumab for severe and critical patients; In the treatment of children's special situations, it is mentioned that neurological complications such as encephalitis and encephalopathy in children can be selected as appropriate; Tocilizumab may be used in children with multisystem inflammatory syndrome (MIS-C) who do not improve or worsen with treatment.

® The global phase III clinical trial was led by Professor Zeng Xiaofeng, Director of the Department of Rheumatology and Immunology of Peking Union Medical College Hospital, with the participation of 55 centers. Professor Zeng Xiaofeng commented: "The biologics tocilizumab have a good effect on autoimmune diseases. Global clinical studies have shown that Shireli ® has a high degree of consistency with the original tocilizumab. Bio-Thera independently developed Shiruili ® is the first approved tocilizumab biosimilar in China and the world's first tocilizumab biosimilar. The listing of Shi Ruili ® will surely bring good news to Chinese patients with autoimmune diseases and provide a new biological agent for our Chinese rheumatology patients. The launch of tocilizumab also provides a new treatment plan for patients with severe new crown disease. We hope that Bio-Thera will continue its efforts to introduce more patient-friendly products in the future." ”

Dr. Shengfeng Li, Founder and CEO of Bio-Thera, said: "We are delighted that Celelican ® has been approved as the world's first tocilizumab biosimilar. The successful listing of Shiruili ® is the result of the joint efforts of many researchers, medical staff, subjects and their families, the company's R&D team and partners around the world. I take this opportunity to express my heartfelt gratitude! The launch of Shiruili ® also provides new treatment options for patients infected with the new coronavirus, especially hospitalized and critically ill patients. As a biomedical enterprise, it is our social responsibility to actively participate in the prevention and treatment of emerging major infectious diseases. As always, the company will continue to actively explore, not only to develop new crown treatment products, but also to explore and research efficient, broad-spectrum preventive biological agents that can prevent infection with new crown epidemic variants, and make due contributions to the control of the epidemic. ”