Grelli was approved for listing, and the adalimumab market ushered in changes.

On November 7, the National Food and Drug Administration (NMPA) approved Gelli (BAT1406)'s application for marketing registration for the treatment of autoimmune diseases such as ankylosing spondylitis, rheumatoid arthritis and psoriasis. Gelli is the first approved adalimumab biosimilar in China, developed by Baiotai Biopharmaceuticals, which will provide new choices for patients.

Tumor necrosis factor TNF-α is a cytokine that is produced during the immune response in humans and has inflammatory effects. TNF-alpha receptor can conduct survival and death signals into cells, and plays an important role in the regulation of immune response. Many clinical trials have demonstrated elevated levels of TNF-α in the synovial fluid of patients with autoimmune diseases such as rheumatoid arthritis. Studies have shown that adalimumab can specifically bind to soluble human TNF-alpha and block its interaction with cell surface TNF receptors p55 and p75, thereby effectively blocking the inflammatory effects of TNF-alpha. In addition, adalimumab may also produce antibody-dependent cell-mediated cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), induction of apoptosis and other effects by binding to transmembrane TNF-alpha, so as to clear some pathogenic target cells.

The original research and development of adalimumab by Abbvie (Abbvie), is the world's first approved anti-tumor necrosis factor TNF-α drug, trade name Humira (Humira), approved by FDA in 2002, approved by EMA in 2003, approved by PMDA in 2008. For more than ten years, the indications that have been approved in many countries or regions around the world mainly include rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, psoriasis, juvenile idiopathic arthritis, psoriatic arthritis, Ulcerative colitis, hidradenitis suppurativa, uveitis and so on. Since its launch for more than 10 years, the drug has been widely verified in the treatment of autoimmune diseases, and has become the world's best-selling TNF-α inhibitor drug, with sales of nearly US $20 billion in 2018, and has won the reputation of "drug king" in the world for the seventh consecutive year.

Compared to the global market, adalimumab sales in China is not ideal. According to statistics from domestic sample hospitals, adalimumab sales were 18.09 million yuan in 2012, 22.08 million yuan in 2016, 17.95 million yuan in 2017 and 16.17 million yuan in 2018, down 9.8 percent from the same period. Sales in the first half of 2019 were 8.21 million yuan. According to the analysis of relevant people, this is mainly due to the limited awareness of rheumatoid arthritis in China, as well as the failure of Xiumile to enter the national medical insurance, and the high cost limits the accessibility of the majority of patients. Although domestic sales are not satisfactory, with more adaptability to domestic listings, many developers have targeted their future markets and

development potential.

According to Frost & Sullivan's report, China's adalimumab biosimilar market is expected to increase to 4.7 billion RMB in 2023 and reach 11.5 billion RMB in 2030. The original research adalimumab antibody sequence patent expired in China in 2017, and as of May 2019, 15 companies in China have conducted clinical trials of adalimumab biosimilars. In addition to Baiaotai first submitted the listing application and successfully won the first imitation, since then Haizheng Pharmaceuticals, Cinda Bio, Fuhong Hanlin also submitted the listing application, and Junshi Bio, Tonghua Dongbao and Shenzhou cell Adalimumab biosimilar drugs have entered clinical Phase III. Many domestic adalimumab biosimilar drugs, once approved, will stir China's adalimumab drug market pattern with price advantage.

In recent years, after the expiration of the patent period of antibody drugs, biosimilars have become a hot spot pursued by domestic enterprises, showing a trend of competing with each other. With the successive launch of these biosimilar drugs, more products will be included in medical insurance and lower the threshold for patient use, thus promoting the overall market size of anti-TNF-alpha antibodies to be in line with international standards, and the adalimumab market in China and even the world will usher in great changes.