Sunshine Guojian obtained clinical trial approval by the FDA for the anti-IL-4Rα monoclonal antibody
3SBio Inc. (01530.HK), a leading biopharmaceutical company in China, announced today that thehumanized monoclonal antibody against interleukin 4 receptor alpha (IL-4Rα) (R&D code: 611)independently developed by its subsidiary, Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.,has recently been approved by the U.S. FDA for clinical trials for the treatment of patients withatopic dermatitis (eczema). 3SBio will conduct clinical trials of such product in the U.S. as soon aspossible. In addition, the application for domestic clinical trials of such product has also recentlybeen accepted by the National Medical Products Administration (NMPA).
Atopic dermatitis affects 18 to 25 million people in the U.S., with approximately 300,000 adultsbeing urgently in need of medication for treatment. In China, the prevalence rate of atopicdermatitis has also gradually increased over the past 20 years. According to statistics, about morethan 2.3 million adolescents and 2 million to 3 million children in China are suffering from atopicdermatitis. In recent years, along with the rapid urbanization and industrialization in China, theincidence rate of atopic dermatitis in China has also gradually increased.
IL-4Rα is part of the signaling complex of interleukin 4 (IL-4) and interleukin 13 (IL-13) andplays a key role in the pathogenesis of atopic dermatitis. 611 can alleviate diseases such asatopic dermatitis by inhibiting IL-4Rα and blocking the signaling of IL-4 and IL-13. At present,corticosteroid drugs are the most commonly used drugs for the treatment of such diseases; however,the serious side effects of these drugs limited their application. Therefore, such diseases still have awide range of unmet clinical needs. Our antibody 611 is expected to bring new treatment options forpatients with atopic dermatitis.
Dr. LOU Jing, the chairman of 3SBio, commented, “We are very pleased that the investigationalnew drug clinical trial application for anti-IL-4Rα monoclonal antibody 611 has been approvedby the U.S. FDA and accepted by the NMPA of China, respectively. We hope to accelerate theprogress of clinical trials of such product. 3SBio will continue to devote itself to exploring anddeveloping safer and more effective therapeutic biological agents, so as to meet the urgent medicalneeds and provide important treatment options for patients with auto-immune diseases.”
611 is an anti-IL-4Rα monoclonal antibody independently developed, designed, screened andhumanized by Sunshine Guojian. 611 has a completely new amino acid sequence, and is able toalleviate diseases such as atopic dermatitis by specifically binding to IL-4Rα and blocking thesignaling of IL-4 and IL-13.
About Sunshine Guojian
Sunshine Guojian was established in 2002 and is one of the first batch of innovativebiopharmaceutical companies focusing on antibody drugs in China. It is a domestic pharmaceuticalcompany that has three launched therapeutic antibody drugs, and had emerged as a leader in antibody drug with its capabilities of independent R&D, industrialization and commercialization inChina. Sunshine Guojian orients its R&D efforts primarily towards innovative therapeutic antibodydrugs, and provides high-quality, safe and effective clinical solutions to the therapeutic areas ofmajor diseases such as auto-immune diseases and tumors. Currently, Sunshine Guojian has 14antibody drug candidates which are under different development stages (including 7 drug candidatesin clinical and post-clinical stage and 7 drug candidates in pre-clinical stage), targeting tumor, autoimmunediseases and ophthalmological diseases. Most of those drug candidates are Category Ibiological products for therapeutic use or monoclonal antibodies, 1 of which are in application forlaunching, and 6 are in clinical stage. Some of those drug candidates may have their applicationsbe submitted to both the NMPA and the U.S. FDA, while some may
3SBio is a leading biopharmaceutical company integrating R&D, production and sales, with a focuson improving the life quality of patients with high-quality medicines to benefit human health. Atpresent, 3SBio owns more than 70 national invention patents and has launched more than 30 kindsof products into the market, covering treatment fields such as oncology, auto-immune diseases,nephropathy, metabolic diseases and dermatology. 3SBio owns 4 R&D centers of the NationalEngineering Research Center of Antibody Medicine and dual platforms for biopharmaceutical andchemical medicine. There are 32 kinds of products under R&D, 17 kinds of them are under R&Das national new drugs. 3SBio also owns 5 production bases complying with the GMP standards.In the future, 3SBio will continue to uphold the concept of “Care for Life, Cherish Life, CreateLife” to create a world’s leading biopharmaceutical company in China. 3SBio is a fully-integratedbiotechnology company in China with market-leading biopharmaceutical franchises in oncology,auto-immune diseases, nephrology, metabolic diseases and dermatology. 3SBio is focusingon building an innovative product pipeline, currently with over 30 product candidates underdevelopment, 22 of which are being developed as national new drugs (including registration Class Iand Biologics Class II) in China. 3SBio’s manufacturing capabilities include recombinant proteins,monoclonal antibodies and chemically-synthesized molecules. 3SBio has research and productioncenters in Shenyang, Shanghai, Hangzhou, Shenzhen and Como, Italy. Please visit www.3sbio.comfor additional information.
Cautionary Note and Forward-Looking Statements
This press release contains forward-looking statements, such as those relating to business orproducts outlook, or Company’s intent, plans, beliefs, expectation and strategies. These forwardlookingstatements are based on information currently available to the Company and are statedherein on the basis of the outlook at the time of this press release. They are based on certainexpectations, assumptions and premises, some of which are subjective or beyond our control.These forward-looking statements may prove to be incorrect or may not be realized in the future.With respect to any new product or new indication, we cannot guarantee that we will be able tosuccessfully develop or eventually launch and market such product or indication. Underlyingthe forward-looking statements is a large number of risks and uncertainties. Further informationregarding such risks and uncertainties may be found in our other public disclosure documents.The scientific information involved may only be preliminary and empirical. Shareholders andpotential investors of the Company are advised to exercise caution when dealing in the shares of the Company.
+86 21 50791207