Benlysta, the world’s first biologic therapy for the treatment of systemic lupus erythematosus (SLE), now approved in mainland China

GSK announced today that Benlysta (belimumab) has been approved by the National Medical Products Administration in China. As the world’s first SLE biologic therapy, Benlysta is now approved in China, and is indicated for intravenous (IV) use as add-on therapy in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) with high disease activity (e.g., positive anti-dsDNA and low complement, SELENA SLEDAI score >=8) despite standard therapy.

Belimumab is an IV infusion human monoclonal antibody that binds to a soluble B lymphocyte stimulator (BLyS). It inhibits proliferation and differentiation of B cells, induces apoptosis of autoreactive B cells, and reduces serum levels of autoantibodies, thus achieving the goal of treating SLE.

Professor Xiaofeng Zeng, Director of the Department of Rheumatology and Immunology at Peking Union Medical College Hospital, said: “There are more than one million patients with SLE in China, most of whom are women at childbearing age[1]. The disease brings huge pain and burden to patients and their families. Although the treatment of SLE has improved in the past years, it remains an urgent issue to better control disease activity, protect organ function, reduce adverse drug reactions and improve the quality of life for these patients. We are excited to see that Benlysta has been approved in China, as it will provide a new treatment option for Chinese patients to improve quality of life.”

Dr. James He, Vice President and Head of Medical Affairs of GSK China, said: “Steroid and immunosuppressive agents are widely used in China for the treatment of patients with SLE. According to the data from the China SLE Treatment and Research Group (CSTAR), infection ranks first among the leading causes of death in SLE[2]. Long-term prognosis is still great challenge as well. It is essential to effectively control disease activity, lower the risk of relapses, reduce organ damage, and decrease drug induced side effects. GSK has always been patient-centric and is committed to bringing innovative medicines and solutions to patients in China. We hope that the approval of Benlysta will bring long-term benefits to patients with SLE.”

Professor Fengchun Zhang, Director of Department of Internal Medicine at Peking Union Medical College Hospital and leading PI of China Phase III Study, said, “A global multi-center clinical study evaluated the efficacy and safety of belimumab in active SLE patients in North Asia, including 49 research centers in China, Japan, and South Korea, among which 517 of the 677 patients enrolled were from China. The results showed that after 52 weeks of treatment with the combination of Benlysta and standard therapy, patients' SLE Responder Index (SRI), especially those in China reached up to 57.8%, and the risk of severe relapses was reduced by 50%, with less dependence on steroids, stable response rates, and similar overall incidence of adverse reactions compared with placebo. 3 Benlysta offers a new treatment option for Chinese physicians and SLE patients.”

Fabio Landazabal, Senior Vice President of Emerging Markets for GSK, said: “GSK is committed to improving the health and quality of human life through R&D and innovation, and is leading the way to help patients and their families manage SLE. As the only medicine specifically developed for SLE and previously approved in other regions like the US and Europe, the approval of Benlysta in China marks a significant milestone. GSK will continue to deliver on our commitment to bring more innovative drugs to China for the benefit of even more Chinese patients.”



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GSK’s commitment to immunology

GSK is focused on the research and development of medicines for immune-mediated diseases, such as lupus and rheumatoid arthritis, that are responsible for a significant health burden to patients and society. Our world-leading scientists are focusing research on the biology of the immune system with the aim to develop immunological-based medicines that have the potential to alter the course of inflammatory disease. As the only company with a biological treatment approved for adult and paediatric lupus, GSK is leading the way to help patients and their families manage this chronic, inflammatory autoimmune disease. Our aim is to develop transformational medicines that can alter the course of inflammatory disease to help people live their best day, every day.



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[1] China Guideline for Systemic Lupus Erythematosus (2010)

[2] Zhang S, et al. Lupus. 2019 Apr;28(5):635-641

[2] Ocampo-Piraquive V, et al. Expert Rev Clin Immunol. 2018 Dec;14(12):1043-1053.