Sunshine Guojian obtained clinical trial approval by the FDA for the anti-IL-4Rα monoclonal antibody
2020-06-28
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.”
About 611
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
About 3SBio
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.