Domestic lupus new drug taitasip declared to market

　　Pharmaceutical Network November 14th, November 13th, CDE official website shows that Rongchang Bio independently developed the systemic lupus 1 new drug injection with tatasip declared on the market 　　Lupus is an autoimmune inflammatory connective tissue disease From the pathogenesis point of view, the mainstream view is that genetic factors, environmental factors, estrogen levels and other factors under the interaction of b cells in the patient's body, produce a large number of autoantibodies, and the corresponding autoantigen binding to form the corresponding immune complex, deposited in the skin, joints, small blood vessels, gloer and other parts, and then in the participation of the complement, causing acute inflammation and tissue necrosis Or antibodies act directly with tissue cell antigens, causing cell damage, resulting in multi-system damage to the body systemic lupu erythematou (SLE) is one of the most common (about 70%) of all types of lupuery, with a variety of clinical manifestations, including large areas of red rash, fever, pain, kidney damage, respiratory and nervous system strain, etc SLE is more frequent in youth , the age of onset of 20 to 40 years old, the traditional treatment prognosis is relatively poor, with the improvement of treatment technology, 10 years survival rate from less than 50% gradually increased to 60% to 70%, but good treatment drugs are still limited, clinical needs are far from being met the drugs commonly used in the treatment of systemic lupus are mainly: glucocorticoids, immunosuppressants, antimalarial drugs, and biologics Long-term use of existing drugs can lead to such as infection, osteoporosis, diabetes and , so there is still an urgent clinical need for new drugs to be available on July 20, GlaxoSmithKline's Bellevue Single Resistance was launched in China Bellevue monoantigen belongs to the specific inhibitor of B lymphocyte stimulator (BLyS, also known as BAFF) of firt in cla, which has a higher affinity with soluble BLyS in the serum, which in turn blocks the binding of BLyS to the receptors on B cells, inhibits the proliferation of B cells and the differentiation of B cells to plasma cells, thereby reducing the autoantibodies produced by B cells in the serum, and is the first new lupus drug in 60 years Tetasip is a TACI-Fc fusion protein with a new drug structure and dual-target mechanism for the treatment of systemic lupus erythematosus, rheumatoid arthritis and other autoimmune Tataxip inhibits both BLyS and APRIL cytokines BLyS and APRIL are the key factors for the differentiation and maturation of B lymphocytes, and the overexpression of this factor is an important cause of various B lymphocytes associated with systemic lupus lupus, which can reduce the immune response of the body more effectively and achieve the goal of treating autoimmune diseases a clinical study of multicenter, randomized, double-blind, placebo-controlled Phase III, which showed that the 48-week lupus response index (SRI-4) in the high-dose group of tatasip was significantly higher than that of the placebo-controlled group (79.2% v32.0%) and reached the main endpoint 　　In addition, secondary endpoint results such as serum indicators were consistent with effectiveness results, supporting the main clinical focus results Tattisip also excels in safety and patient tolerance Tataip is expected to be a firt-in-cla innovative biopharmaceutical to meet the enormous clinical needs of systemic lupus erythematosus, bringing new treatment options to Chinese patients china's epidemiological survey report shows that the prevalence of systemic lupus is 70 per 100,000 people There are about 1 million patients in China and 5 million in the world.