New domestic lupus erythematosus drug Tacitazep declared for listing

Source: Medical Network

Lupus erythematosus is an autoimmune inflammatory connective tissue disease. From the perspective of pathogenesis, the mainstream view is that genetic factors, environmental factors, estrogen levels and other factors interact to cause excessive proliferation of B cells in patients, produce a large amount of autoantibodies, and combine with corresponding autoantigens in the body to form corresponding The immune complex is deposited on the skin, joints, small blood vessels, glomeruli and other parts, and then with the participation of complement, it causes acute and chronic inflammation and tissue necrosis. Or the antibodies directly interact with the tissue and cell antigens, causing cell destruction, resulting in multiple system damage to the body.

Systemic lupus erythematosus (SLE) is the most common (approximately 70%) and most severe of all types of lupus erythematosus, and its clinical manifestations include a wide range of red rashes, fever, pain, kidney damage, Respiratory and nervous system involvement, etc. SLE is more common in young women. The age of onset is 20 to 40 years old. The prognosis of traditional treatment is relatively poor. With the improvement of treatment technology, the 10-year survival rate gradually increased from less than 50% to 60% to 70%. Treatments are still limited and clinical needs are far from being met.

At present, the drugs commonly used in clinical treatment of systemic lupus erythematosus mainly include: glucocorticoids, immunosuppressants, antimalarials, and biological agents. Long-term use of existing drugs can cause adverse reactions such as infection, osteoporosis, diabetes, and hypertension, so new drugs are still urgently needed for clinical application.

On July 20, Beleuzumab developed by GlaxoSmithKline was launched in China. Beilizumab belongs to the first class of specific inhibitors of B lymphocyte stimulating factor (BLyS, also called BAFF), which has a higher affinity for soluble BLyS in the serum, thereby blocking the receptors on BLyS and B cells. It can inhibit the proliferation of B cells and the differentiation of B cells into plasma cells, thereby reducing the autoantibodies produced by B cells in the serum and achieving the purpose of treating SLE. It is the first new drug for lupus erythematosus in 60 years.

Tatarcept is a TACI-Fc fusion protein with a new drug structure and a dual-target mechanism of action. It is used to treat systemic lupus erythematosus, rheumatoid arthritis and other autoimmune diseases. Tatarcept can inhibit both BLyS and APRIL cytokines. BLyS and APRIL are the key factors for the differentiation and maturation of B lymphocytes. The overexpression of this factor is an important cause of various B lymphocyte-related autoimmune diseases such as systemic lupus erythematosus. Response to achieve the purpose of treating autoimmune diseases.

A multi-center, randomized, double-blind, placebo-controlled phase III clinical study showed that the 48-week lupus response index (SRI-4) of the treatment group of the high-dose tacicept group was significantly higher than that of the placebo control group (79.2% vs 32. 0%), reaching the primary end point.

In addition, secondary endpoint results such as serum indicators are consistent with efficacy results, supporting major clinically important results. Tacitazep also excels in safety and is well tolerated by patients. Teltaxip is expected to become a first-in-class innovative biopharmaceutical that meets the huge clinical needs of systemic lupus erythematosus, bringing new treatment options to Chinese patients.