Etanercept (Recombinant Human Tumor Necrosis Factor-αReceptorⅡ: IgG Fc Fusion Protein for Injection)
Etanercept can restrain the activation of some specific inflammatory protein (TNF), to control the inflammation better and obviously relieve the rheumatic diseases, such as rheumatoid arthritis, ankylosing spondylitis, morning stiffness, pain, swelling, low back pain and skin lesions of psoriasis and other clinical symptoms.
Etanercept was marketed in 2005, and is the first antibody fusion protein medicine marketed in the rheumatism field of China. 2 kinds of indications were approved by CFDA: Treatment of rheumatoid arthritis (approved in 2005), ankylosing spondylitis and psoriasis (approved in 2007).
Etanercept broke through the blank record in terms of therapeutic antibodies for treatment in our country. It has acquired lots of awards in China such as Chinese National New Drug Certificate, National Key New Product, National Second Prize on Technical Invention, Gold Patent Award of China and other national awards.
There are over 700 evidences of evidence-based medicine in China. Through observing 3,598 samples (biggest in China) in clinical after marketed, it is proved that Etanercept is characterized by definite therapeutic effect, low immunogenicity and long-term therapeutic effect. As for the safety research of biological products with 2,041 samples (biggest in China), the occurrence rates of the phthisis and infection are lower than other similar products.
Etanercept is the first Enbrel product marketed in China and has taken the leading position since 2006, and it took the absolute dominant position in 2016 by virtue of 62.7% market share. Monoclonal antibody market of China with low permeability has huge growth potential, and therefore Etanercept is still at the initial stage of its lifecycle.
It is included into the Type B drugs of 2017 National Reimbursement Drug List
Etanercept has been approved for marketing in 9 countries, and is pending for approval in 18 countries.