The world's first biological agent for the treatment of systemic lupus erythematosus has been approved for marketing in China

July 16, 2019 / AP / -- GSK announced on July 16 that belitton (generic name: berylumab for injection) was approved by the State Drug Administration for marketing As the world's first approved biological agent for the treatment of systemic lupus erythematosus, belitton is approved to be combined with conventional treatment in China, which is applicable to the adult patients with active and autoantibody positive systemic lupus erythematosus (SLE) who still have high disease activity on the basis of conventional treatment Baileyuzumab is a kind of all human monoclonal antibody It can inhibit the proliferation and differentiation of B cells by intravenous administration, induce the apoptosis of self reactive B cells, so as to reduce the autoantibody in serum and achieve the purpose of treating systemic lupus erythematosus Professor Zeng Xiaofeng, director of Rheumatology and Immunology Department of Peking Union Medical College Hospital, said: "at present, there are more than one million patients with systemic lupus erythematosus in China, mainly concentrated in women of childbearing age [1], and the disease has brought huge pain and heavy burden to patients and their families Although the ten-year survival rate of SLE patients has been improved at present, how to better control disease activity, delay organ damage, reduce adverse drug reactions and improve the quality of life is an urgent problem to be solved We are very pleased to see belitan approved in China, which will bring new treatment options and hope to Chinese patients " He Lijing, medical doctor, vice president of GSK China Medical Affairs, pointed out: "the current treatment of systemic lupus erythematosus is more dependent on hormones and immunosuppressants According to the data of CStar, infection ranks first in the main causes of death of SLE [2] The proportion of infection deaths in Chinese patients is higher than that in western countries [3], and the long-term prognosis of patients also faces greater challenges Therefore, it is very important to effectively control disease activity, reduce the risk of recurrence, reduce organ damage and drug-induced side effects GSK has always been patient-centered, committed to providing a series of innovative drugs and personalized treatment programs, and we hope that the approval of bereton will truly benefit lupus patients in the long term " Professor Zhang Fengchun, director of the Department of internal medicine of Peking Union Medical College Hospital, said: "the international clinical multicenter study led by Peking Union Medical College Hospital from 49 research centers in China, Japan and South Korea evaluated the efficacy and safety of beilitang in patients with active SLE in Northeast Asia, including 677 Asian patients, 517 of whom were from China The results indicate that in Asia, especially in China, the combined response rate of BLT and conventional therapy for 52 weeks is up to 57.8%, and the risk of severe relapse is reduced by 50% At the same time, the dependence of patients on hormone is significantly reduced and the condition is stable The overall adverse reaction rate is similar to that of placebo [3] Beilitang will bring new treatment options for Chinese doctors and SLE patients " "GSK has been committed to helping improve people's health and quality of life through R & D and innovation," said Fabio landazabal, senior vice president of emerging markets at GSK As the first drug approved by FDA since 1955, as well as the world's first bio targeting agent for the treatment of SLE, beilitang has a milestone significance in China's listing GSK will continue to fulfill our commitment to bring more innovative drugs into China for the benefit of more Chinese patients " References: [1] 2010 guidelines for the diagnosis and treatment of SLE in China [2] Zhang s, et al.lupus.2019apr; 28 (5): 635-641 [3] Zhang F, et al.ann rheumdis.2018mar; 77 (3): 355-363 Source: GlaxoSmithKline