(Shanghai, China, February 25, 2020) 3SBio (01530.HK), China's leading biopharmaceutical company, announced today that Recombinant Humanized Anti-Interleukin-5 (IL-5) Monoclonal Antibody Injection (hereinafter referred to as 610) independently developed by its subsidiary, Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd., has been approved for clinical trial by the National Medical Products Administration (NMPA). The company will start to enroll patients for clinical trial in China as soon as possible after getting the approval.
According to the Prevalence, risk factors, and management of asthma in China: a national cross-sectional study published in the Lancet in 2019, the prevalence of asthma in the population aged 20 years and above in China was 4.2%, with the number of patients hitting 45.7 million. [1] At present, the standard clinical treatment of asthma in China is anti-inflammatory therapies, including inhaled glucocorticoids, β2 receptor agonists, leukotriene modulators, anticholinergics, phosphodiesterase inhibitors, theophyllines, antihistamines and other anti-allergic drugs. However, these therapies still cannot effectively control symptoms for patients with severe asthma, and systemic glucocorticoid therapy may even be required. Meanwhile, systemic side effects such as osteoporosis, infection and growth restriction may be incurred. Therefore, identifying new targets for asthma treatment, reducing acute attacks of hormone-insensitive asthma patients, relieving asthma symptoms, improving lung function and boosting the quality of life of asthma patients have become new strategies for clinical treatment of asthma.
Research showed that reducing airway eosinophilia can more effectively improve asthma symptoms and reduce the number of acute exacerbations compared with standard therapies. At present, many research programs on reducing eosinophil activity focus on the homodimer-induced cytokine IL-5. Compared with IL-3 and GM-CSF, IL-5 has less influence on the immune system and is an "ideal" molecular target. Therefore, blocking the biological effect of IL-5 can be used as a strategy for targeted therapy of asthma [2, 3].
Dr. Lou Jing, chairman and CEO of 3SBio, commented: "We are very pleased to see that the application for clinical trial of 610 has been approved by NMPA. Meanwhile, it is expected to accelerate the clinical trial process of this product. 3SBio will continue to look for opportunities to explore and develop safer and more effective therapeutic biologics to meet urgent medical needs and provide important treatment options for patients with autoimmune diseases.”
References:
[1] Prof Kewu Huang, MD, Ting Yang, MD, Prof Jianying Xu, MD, et al. Prevalence, risk factors, and management of asthma in China: a national cross-sectional study. Lancet. June 2019.
[2] Shi Hao, Yang Yue, Fang Wei, Xu Hongwei. Progress in clinical application of anti-interleukin targeted therapy for bronchial asthma. China Medical Herald, 2011; 8 (36): 19-20.
[3] Shi Haiguang, Yang Xuemin, Cheng Jiajun, Li Zhikui. Research progress in targeted treatment of bronchial asthma with anti-interleukin. Chinese Journal of Lung Diseases, 2010; 3 (3): 198-203.
About 610
Recombinant Anti-IL5 Humanized Monoclonal Antibody Injection (hereinafter referred to as 610) is a new recombinant humanized IgG1 type 1 monoclonal antibody independently developed by our company. 610 blocks IL5 from binding to its receptor by binding to IL 5, thus playing a role in inhibiting eosinophil proliferation, differentiation and activation. Clinically, it is intended to be used as additional treatment for maintenance therapy of severe eosinophilic asthma.
About Sunshine Guojian
Sunshine Guojian was established in 2002 and is one of the first batch of innovative biopharmaceutical companies focusing on antibody drugs in China. It is a domestic pharmaceutical company that has two launched therapeutic antibody drugs, and had emerged as a leader in antibody drug with its capabilities of independent R&D, manufacturing and commercialization in China. Sunshine Guojian orients its R&D efforts primarily towards innovative therapeutic antibody drugs, and provides quality, safe and effective clinical solutions to the therapeutic areas of major diseases such as auto-immune diseases and tumors. Currently, Sunshine Guojian has 15 anti-body drug candidates (including 7 drug candidates in clinical and new drug registration stage and 8 drug candidates in pre-clinical stage) which are under different development stages, targeting tumor, auto-immune diseases and ophthalmological diseases. Most of those drug candidates are Category I biological products for therapeutic use or monoclonal antibodies, 2 of which are in application for launching, and 5 are in clinical stage. Sunshine Guojian may submit applications to both the National Medical Products Administration and the US Food and Drug Administration for some of those drug candidates, or some may be admitted for priority evaluation. Please visit www.ynzqzl.com for additional information.
About 3SBio
3SBio is a fully integrated biotechnology company in China with market-leading biopharmaceutical franchises in oncology, auto-immune diseases, nephrology, metabolic diseases and dermatology. 3SBio is focusing on building an innovative product pipeline, currently with over 30 product candidates under development. 3SBio’s manufacturing capabilities include recombinant proteins, monoclonal antibodies and chemically synthesized molecules, with research and production centers in Shenyang, Shanghai, Hangzhou, Shenzhen and Como, Italy. Please visit www.3sbio.com for additional information.
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